Search results for "Pharmaceutical Consulting"

Jobba för originalet. Välkommen till Apoteket, nummer ett sedan 1971. Med visioner för framtiden och kvalitet i varje detalj, skapar vi förutsättningar för ett liv i hälsa. Hos oss utvecklas du i en kultur där din röst alltid blir hörd. Och allt vi får över ger vi tillbaka till samhället. Det är så vi gör skillnad på riktigt. Om Apoteket Svanen Hos oss på Apoteket Svanen blir du en del av ett engagerat och stabilt team i Markaryd. Apoteket ligger nära en vårdcentral och vi är stolta över våra många stamkunder och de goda relationer vi bygger i vårt dagliga arbete. Utöver våra kunder som besöker oss har vi andra arbetsuppgifter vilket skapar en god variation i vårt vardagliga arbete. Här arbetar tre farmaceuter, inklusive apotekschefen och en tekniker, vi är ett sammansvetsat gäng som samarbetar prestigelöst och hjälps åt i vardagen. Arbetstiderna för denna tjänst ligger inom ramen för det lokala apotekets öppettider: vardagar 09.00-18.00, lördagar & söndagar stängt. Din roll Våra farmaceuter arbetar alltid med omtanke, kvalitet och kundens behov i fokus. I din roll hos oss bidrar du till en trygg, professionell och välkomnande upplevelse för alla som besöker oss. I din roll har du hand om rådgivning, receptexpedition och egenvård, och tar ansvar för trygghet och service i varje kundmöte. Vi vill ge dig möjligheter att utvecklas och för denna tjänst finns det möjlighet att ta rollen som exempelvis LMA för den som är intresserad. Vad du kommer att göra hos oss: Ge professionell rådgivning och skapa mervärde i varje kundmöte, med omtanke och förståelse för människors olika behov. Bidra till patientsäkerhet och kvalitet i allt du gör, så att våra kunder kan känna sig trygga med oss. Dela kunskap och erfarenhet med dina kollegor – vi växer och utvecklas tillsammans. Hålla dig uppdaterad kring vårt sortiment och våra kampanjer, för att ge kunderna bästa möjliga hjälp. Bidra med idéer och initiativ för att utveckla både arbetsvardagen och kundupplevelsen på vårt apotek. Vem söker vi? För den här tjänsten behöver du vara legitimerad receptarie eller apotekare, med ett tydligt intresse för människor, hälsa och läkemedel. Du kan antingen vara nyexaminerad eller har erfarenhet som farmaceut på apotek sedan tidigare. Det är meriterande om du har ett intresse och erfarenhet av att arbeta som LMA. Du har ett varmt och professionellt bemötande där du ser varje kund. Du samarbetar gärna och bidrar positivt till team. Vi tror att du trivs i ett sammanhang där struktur och resultat går hand i hand. Vi erbjuder... Friskvårdsbidrag: 5000 kr per år. Personalrabatt: Förmånliga priser på många av våra produkter. Flexibla helgdagar: Möjlighet att byta arbetsfria helgdagar mot andra dagar på året. Förmånsportal (Benifex): Erbjudanden inom bland annat kollektivtrafik, leasingbil, gym och hälsobehandlingar. Trygga försäkringar: Förstärkt föräldrapenning, tjänstepension (ITP) och kompletterande försäkringar. Om oss Apoteket grundades 1971 och ägs av svenska staten, vilket innebär att vi arbetar både ansvarsfullt och långsiktigt. Vårt viktiga samhällsuppdrag handlar om att förbättra människors hälsa, läkemedelsanvändning och bidra till ökad patientsäkerhet. Med omkring 400 apotek och 3000 medarbetare över hela landet har vi nära samarbete med hälso- och sjukvården – alltid med omtanke om både människor och miljö. Vårt mål är tydligt: Ett liv i hälsa, för alla. Nyfiken? Det räcker gott. Hör av dig om rollen fångar ditt intresse! Vi berättar gärna mer om tjänsten och vår verksamhet – så du får en tydligare bild och kan avgöra om det känns helt rätt. Vänta bara inte för länge, urval och intervju sker löpande och tjänsten kan tillsättas innan sista ansökningsdatum. Skicka ditt CV tillsammans med svar på våra urvalsfrågor. Du behöver inte skriva ett personligt brev – frågorna är utformade för att hjälpa oss förstå mer om dina erfarenheter och kompetenser för matchning mot tjänst. Vi använder tester för objektivt urval som en del av vår rekryteringsprocess. Provanställning tillämpas. Välkommen till Apoteket!

Beskrivning av jobb Är du legitimerad farmaceut och är redo för din nästa utmaning? Vill du vara en del av en organisation där du kommer att ha ett nära samarbete med ditt team och stora möjligheter att utvecklas i olika roller? Välkommen till Apotek Hjärtat! Om jobbet som farmaceut på Hjärtat Som farmaceut på Hjärtat arbetar du omväxlande med rådgivning och försäljning inom recept och egenvård. I rollen bidrar du med din farmaceutiska kompetens, engagemang och erfarenhet, till en bättre hälsa för våra kunder och till apotekets framgång. På Hjärtat kan din karriär som farmaceut ta många spännande vägar. Du kan leda andra och specialisera dig inom till exempel farmaci, kvalitet eller kundmöte. Möjligheterna är många! Läs mer om våra karriärvägar här. Därför ska du jobba hos oss - apotekschefen berättar Vi söker dig som är en engagerad farmaceut som vill leverera riktigt bra kundservice tillsammans med oss. Vi har ett stort utbud av egenvård på vårt apotek och en kundgrupp som uppskattar vår kompetens inom området egenvård i kombination med rådgivning vid recepthantering. Hos oss får du också mölighet till omväxling genom att vid behov även stötta vår e-handel med kundmöten på distans. Vi arbetar som ett lag och ser en glädje i att gemensamt nå uppsatta försäljningsmål och vi gärna firar tillsammans när vi lyckas. Vi söker därför dig som vill bidra till det genom att dela kunskap via ett coachande förhållningssätt mellan kollegor. För mig som chef, är det av stor vikt att du är engagerad, målinriktad och tar egna initiativ i din roll som farmaceut och ser till att kundens behov med rådgivning och säkerställande av rätt läkemedelsanvändning uppfylls samt att du brinner för mervärdesförsäljning och bidrar till en god laganda för att nå våra gemensamma mål. Vi har öppet vardagar 08–18, lördagar 10–15 och söndagar 10–15. Vi är ett härligt team som ger det lilla extra i varje kundmöte. Tjänsten är tillsvidare. Tjänsten är på heltid alternativt deltid. Tillträde till tjänsten sker snarast möjligt eller enligt överenskommelse. Är du den vi söker? Vi söker dig som är legitimerad receptarie eller apotekare. Du är antingen i början av din karriär eller erfaren farmaceut och känner igen dig i beskrivningen: Du visar intresse och engagemang i mötet med kunder och samarbetar väl med kollegor på ditt apotek och i hela regionen/ hela Apotek Hjärtat Du tar ansvar för att hantera de krav som ställs på dig som farmaceut och tar hjälp av ditt team vid behov Du bidrar med en god attityd och söker enkla lösningar i vardagen Nyfiken på att lära känna våra kollegor? Lyssna på vår podcast. Du hittar den här! På Hjärtat strävar vi efter en jämn könsfördelning och ser mångfald som en styrka. Vi välkomnar därför sökande med olika bakgrund! Intervjuer sker löpande och tjänsten kan komma att tillsättas innan sista ansökningsdagen, skicka in din ansökan redan idag. Om roller kräver det så behöver du genomgå bakgrundskontroller innan anställning. All extern hjälp med rekrytering undanbedes. Sista ansökningsdag: 20326-09-30 Kontaktperson: Sara Almqvist Välkommen till oss - ett apotek med Hjärtat på rätt ställe!

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role, you will get the opportunity to work with committed colleagues in a collaborative team, close to both commercialised products and development projects. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the outsourced manufacturing processes throughout the product lifecycle. We are looking for an experienced Senior Process Engineer to join our Manufacturing Operations team. In this role, you will be responsible for leading technology transfer activities for manufacturing processes for injectable pharmaceutical products, from development into manufacturing environments at Contract Manufacturing Organizations (CMOs). You will support products from clinical development through to commercial supply. As Senior Process Engineer, you will act as a subject matter expert in pharmaceutical manufacturing processes, working closely with internal stakeholders and external partners to ensure robust, scalable, and GMP-compliant manufacturing operations. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Lead technology transfers of injectable pharmaceutical products from development into commercial manufacturing at CMOs. · Partner with R&D to ensure that formulation and process development activities support successful scale-up, manufacturability, and long-term process robustness. · Provide technical support for process development, scale-up, validation, and commercial manufacturing activities at CMOs. · Act as technical lead for investigations and troubleshooting of process deviations, OOS results, manufacturing failures, and other complex technical challenges. · Contribute to CMC documentation in support of global regulatory submissions and product lifecycle management. · Ensure that manufacturing processes are executed in accordance with applicable GMP requirements and regulatory expectations. Candidate profile We are looking for a professional with at least 7 years of experience from pharmaceutical manufacturing operations. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have hands-on experience from manufacturing process development, technology transfer, and GMP-regulated pharmaceutical manufacturing, preferably within sterile or injectable products. Experience from fill-finish operations and combination products development is considered a strong merit. As a person, you are collaborative, responsible, and driven by solving problems. You enjoy getting to the bottom of complex technical challenges and you are a pragmatic team player who takes ownership and follows through on commitments. At the same time, you are humble and low-prestige, always willing to support colleagues and contribute wherever needed. You thrive in a dynamic environment where technical expertise, collaboration, and problem-solving go hand in hand. Fluency in spoken and written English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!

Professional Galaxy is an IT and technology consulting company that provides highly specialized expertise within IT, software development, SAP, purchasing, electronics and mechanical design. We collaborate with experienced senior experts and deliver strategic value-creating expertise to some of Sweden's most complex and analytically demanding projects. Our focus is always on high quality, professionalism and clear, measurable results. We are now seeking a Supply Chain Manager for Clinical Trial medications for one of our clients. About the assignment: Would you like to utilize your planning and supply chain knowledge to lead clinical supplies for your portfolio of global clinical studies? With constant new products and launches, there has never been a better time to join Global Clinical Supply Chain and shape our future with a significant contribution to life-changing medicines. We have an exciting opportunity for talented Supply Chain Managers to join our Clinical Study Supply Chain team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams, and we make sure clinical trial medications are available at the right quality, in the right quantity at the right time for every patient taking part in xx trials all over the world. Our goal is to never miss a patient. In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Tasks and responsibilities/The role: In this role you will project manage the design, plan, and set-up of the study supply chain to ensure on time delivery of clinical supplies. You will also lead a cross-functional team enabling continuous dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study. To be successful in this role you need to be a fast learner, self-driven and comfortable working in a high pace R&D environment. You need to be a collaborative team player, flexible and have strong communication, planning and problem-solving skills. Your main responsibilities will include: • Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. • Ensure effective communication with project teams and key partners across a global network. • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies. • Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction. • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning. • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls. Soft skills: • Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries • Ability to adapt and operate in bespoke multiple systems. Desirable for the role: • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice) • Knowledge of clinical development processes relevant to the supply of clinical materials • Lean knowledge and understanding • Experienced in handling Quality Events (Deviations, Change Controls, Complaints Location: Göteborg Start date: 2026-06-01 End date: 2027-05-31 Application Deadline: 2026-04-19 Are you the right person for the assignment, or do you want to recommend a strong candidate? Do not hesitate to contact us. Please apply directly through our system with: - Your updated CV in english - Availability to start the assignment In the motivation, describe why you are suitable for this assignment - refer to previous consulting assignments, employmxent, education and personal qualities. Please note: We do not accept any applications through mail. All applications have to be sent through the portal to be valid. Offer continuously: Please note that for this role we offer continuously. That means that we sometimes remove the assignments before the deadline. If you are interested, we recommend that you apply immediately.

We invite you to come grow with us. Research Partnership (part of Inizio Ignite) is one of the world's largest pharma market research and consulting agencies with over 250 researchers, consultants, project managers and support staff. Our teams are located across the globe, in Europe (London, Lyon), North America (New York, Philadelphia, San Francisco), India (New Delhi), and Singapore. As individuals with diverse backgrounds, as a team with shared values, as professionals ready to reimagine health and life sciences—you can grow with us at a place that: * Makes a difference to human health * Shares values and celebrates progress * Puts people at the center of everything   About the team:  Our custom research team partners with global pharmaceutical and biotech clients to enable them to solve marketing, brand, advertising and communications problems through a mixture of innovative qualitative and quantitative market research techniques. You will be empowered to develop broad expertise across the healthcare landscape, and will have the opportunity to work with a wide range of expert senior researchers and gain exposure to the full suite of research tools and techniques covered by the team. Our studies are typically multi-market, encompassing Europe, North America and Emerging Markets. We believe that exposure to a wide range of healthcare systems – and different cultural approaches to healthcare – helps our researchers to offer the most impactful, commercially-relevant insights to our clients.   Your primary role: * Lead projects and project teams, be the main point of contact with the client and write and give client presentations * Line management of multiple individuals with the responsibility of conducting appraisals, pay reviews, monitoring of performance, personal development, training of staff, recruitment and developing and implementing internal company procedures * Engage in business development and sales initiatives * Write proposals to win new business, consider timescales and calculate the research cost alongside VPs and operations * Involvement in talent acquisition and assessing potential new staff    About You…  Your skills and experience: * At least 7 years of experience with qualitative custom primary market research projects * Experience in the life sciences sector * Extensive expertise in qualitative market research methodologies, including advanced moderation techniques, delivering actionable insights across diverse markets * Proven ability to mentor and develop both junior and senior team members, fostering deep expertise in qualitative research practices and pharmaceutical industry knowledge * Highly skilled in moderating in-depth interviews and focus groups, both via telephone and in-person, ensuring rich, meaningful data collection and analysis * Strong client engagement and relationship management skills * Proven project supervision skills * Appreciation of marketing/client-side issues, knowledge and understanding of client issues * Self-motivated and able to work independently * Excellent communication skills, both verbal and written * Ability to multitask under pressure and meet tight deadlines   Ideal profile: * You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach * You demonstrate a high level of accuracy and attention to detail, as well as strengths in organization and prioritization * You are a collaborative team player who works well with colleagues * You communicate ideas and issues in an effective, straightforward fashion * You are highly motivated and want to seize opportunities to develop new skills and progress your career   Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: * A relaxed and friendly working environment * Social events - including a summer day out and end of year party, along with regular social events after office hours * Fundraising and charity events – we support Forever Angels, a children's charity whose aim is to care for abandoned babies in Tanzania, Africa    Employee Benefits: * A comprehensive training and development program * Opportunities for internal advancement * Annual salary and promotion review * Paid time off, up to 25 days including your birthday * 401(k) plan with employee match * Medical/vision/dental/prescription insurance plans, including heath savings and flexible spending accounts * Company paid life insurance * Short term/long term disability * Commuter reimbursement accounts * Employee assistance program    Our Pledge At Research Partnership, we value inclusivity, recognize the power of diversity, and inspire the next generation of change-makers. We are an equal opportunities employer. We believe in creating a work environment that values diversity, equity, and inclusion. We aim to recruit from a diverse slate of candidates and foster an environment that provides the right conditions for long-term success. We welcome all applications regardless of race, colour, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. Inizio Ignite, Research Partnership  Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.     Further information: This is a full-time role. You can choose to work out of our NYC, SF or Yardley, PA (Philadelphia) office for as many days out of the week as you’d like or work remotely. #LI-ND1 #LI-Hyrbid   The base salary range represents the low and high end of the salary range for this position. This range may differ based on your experience and skill set, geographic location, and cost of living considerations. We consider compensation more than just a base salary – that’s why we also offer an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. Compensation $125,000—$160,000 USD Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

We invite you to come grow with us. Research Partnership (part of Inizio Ignite) is one of the world's largest pharma market research and consulting agencies with over 250 researchers, consultants, project managers and support staff. Our teams are located across the globe, in Europe (London, Lyon), North America (New York, Philadelphia, San Francisco), India (New Delhi), and Singapore. As individuals with diverse backgrounds, as a team with shared values, as professionals ready to reimagine health and life sciences—you can grow with us at a place that: * Makes a difference to human health * Shares values and celebrates progress * Puts people at the center of everything About the team:  Our custom research team partners with global pharmaceutical and biotech clients to enable them to solve marketing, brand, advertising and communications problems through a mixture of innovative qualitative and quantitative market research techniques. You will be empowered to develop broad expertise across the healthcare landscape, and will have the opportunity to work with a wide range of expert senior researchers and gain exposure to the full suite of research tools and techniques covered by the team. Our studies are typically multi-market, encompassing Europe, North America and Emerging Markets. We believe that exposure to a wide range of healthcare systems – and different cultural approaches to healthcare – helps our researchers to offer the most impactful, commercially-relevant insights to our clients. Your primary role: * Lead projects and project teams, be the main point of contact with the client and write and give client presentations * Line manage multiple individuals with the responsibility of conducting appraisals, pay reviews, monitoring of performance, personal development, training of staff, recruitment and developing and implementing internal company procedures * Engage in business development and sales initiatives generating approximately $1m in annual revenue * Write proposals to win new business, consider timescales and calculate the research cost alongside VPs and operations * Involvement in talent acquisition and assessing potential new staff   About You… Your skills and experience:  * At least 7 years of experience with qualitative and quantitative custom primary market research projects * Experience in the life sciences sector * Strong client engagement and relationship management skills * Experience driving revenue growth to meet business development goals * Proven project supervision skills * Appreciation of marketing/client-side issues, knowledge and understanding of client issues * Self-motivated and able to work independently * Excellent communication skills, both verbal and written * Ability to multitask under pressure and meet tight deadlines * Experience with advanced analytics, SPSS, SAS, and/or Q is a plus  * Experience in qualitative market research methodologies, including advanced moderation techniques, and delivering actionable insights across diverse markets  Ideal profile: * You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach * You demonstrate a high level of accuracy and attention to detail, as well as strengths in organization and prioritization * You are a collaborative team player who works well with colleagues * You communicate ideas and issues in an effective, straightforward fashion * You are highly motivated and want to seize opportunities to develop new skills and progress your career Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: * A relaxed and friendly working environment * Social events - including a summer day out and end of year party, along with regular social events after office hours * Fundraising and charity events – we support Forever Angels, a children's charity whose aim is to care for abandoned babies in Tanzania, Africa  Employee Benefits: * A comprehensive training and development program * Opportunities for internal advancement * Annual salary and promotion review * Paid time off * 401(k) plan with employee match * Medical/vision/dental/prescription insurance plans, including heath savings and flexible spending accounts * Company paid life insurance * Short term/long term disability * Commuter reimbursement accounts * Employee assistance program  Our Pledge At Research Partnership, we value inclusivity, recognize the power of diversity, and inspire the next generation of change-makers. We are an equal opportunities employer. We believe in creating a work environment that values diversity, equity, and inclusion. We aim to recruit from a diverse slate of candidates and foster an environment that provides the right conditions for long-term success. We welcome all applications regardless of race, colour, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. Inizio Ignite, Research Partnership  Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.  Further information: This is a full-time role. We have hybrid work arrangements available in New York, NY and Yardley, PA with an expectation of one day per week in-person and the remaining days remote (or travel as needed to meetings, conferences, or the client). #LI-ND1 #LI-Hybrid Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Cleeven is an Engineering, R&D and IT consulting group enabling our clients support in their R&D efforts and operational excellence. We have know-hows in terms of innovation and R&D in a wide range of sectors: energy, services & banking, aerospace & defence, transportation, pharmaceuticals & chemicals, as well as IT & Telecoms. We are currently expanding our team and looking for talented and passionate software developers to join our dynamic team. As a software developer, you will play a crucial role in crafting and implementing software solutions across various projects and industries. Your responsibilities Designing, coding, and testing software applications Collaborating with engineers and stakeholders to understand project requirements Contributing to architectural design and system integration Ensuring software meets quality standards and performance metrics Continuously researching and implementing best practices in software development Qualifications Degree in Computer engineering, Electrical Engineering or similar Proven experience in software development Strong problem-solving skills and ability to work in a team environment Good communication and collaboration abilities A passion for learning and adapting to new technologies and methodologies The most common technical tools and programming languages ​​we use on our projects in this field are: Programming languages: C, C++, C# Scripting: Python, bash, Model-based development: Matlab - Simulink DevOps tooling: Jenkins, IAR compiler, GIT, gerit Documentation: Confluence Methodologies: Scrum / Agile Currently we are recruiting 2 people, one within test and one within development. This is a permanent employment. Due to the nature of the employment, relocation in Sweden might be considered during your tenure.

Cleeven is an Engineering, R&D and IT consulting group enabling our clients support in their R&D efforts and operational excellence. We have know-hows in terms of innovation and R&D in a wide range of sectors: energy, services & banking, aerospace & defence, transportation, pharmaceuticals & chemicals, as well as IT & Telecoms. We are looking for talented electronics engineers to join our team. As an electronics engineer, you will be instrumental in the design, development, and implementation of cutting-edge electronic systems. Your role will involve collaborating with multidisciplinary teams to deliver high-quality solutions across a range of projects. Your responsibilities Designing and developing electronic systems and components Conducting feasibility studies and prototyping Collaborating with cross-functional teams on system integration Testing and troubleshooting electronic circuits and systems Contributing to innovation and research in electronics engineering Qualifications Degree in Electronics/Electrical Engineering or similar Experience in electronics design, simulation, and testing methodologies Familiarity with power or analog electronic and PCB design tools such as ALTIUM or CADENCE. Familiarity with digital electronics and hardware description languages ​​such as VHDL or Verilog Strong analytical skills and attention to detail Ability to work collaboratively in a team environment Previous experience from - and understanding of embedded systems, electric power technologies as well as testing and verification of software or hardware systems is meritorious. Currently we are recruiting 2 people, one within test and one within development. This is a permanent employment. Due to the nature of the employment, relocation in Sweden might be considered during your tenure.

At Nouryon, our global team takes positive action every day, to reach higher collectively and individually. We create innovative and sustainable solutions for our customers to answer society’s needs – today and in the future. We are looking for team members who bring ideas forward, champion others and work together to do better. Does that sound like you? About the job In this exiting role you will manage, drive and coordinate environmental investigations and remediation projects across Europe, ensuring compliance with regulatory requirements and responsible handling of soil and groundwater contamination. You will play a key part in managing environmental risks from both a sustainability and business perspective, while supporting sound financial planning through environmental reserves and contributing to the long-term strategy for managing environmental liabilities. You will be a part of the Nouryon Environmental Liability Management team, which is a part of corporate legal, with highly skilled and dedicated colleagues and partners around the globe. The role can be based in either Sweden Gothenburg or in the Netherlands, Amsterdam. In your future role as Environmental Liability Project Manager - Europe you will Be responsible for managing impaired sites and environmental liabilities across Nouryon’s European portfolio, ensuring compliance, cost control, and protection of company reputation. Monitor and control investigation and remediation costs, including invoice approval and environmental liability provisioning. Manage consultants and contractors, including scope definition, performance follow-up, cost control, and review of deliverables. Maintain relationships with Nouryon sites, regulatory authorities and key stakeholders. Support development of remediation strategies, including safety, budgeting, coordination with functions (Legal/Finance/HSE), and stakeholder engagement. Contribute to continuous improvement of ELM procedures and guidelines. Support M&A activities through environmental due diligence as needed. Travel as required for site visits (mainly Sweden, the Netherlands, Germany, Belgium and France) and stakeholder engagement. Travel varies but can during periods be expected to be up to 20%. We believe you bring Academic degree in science or engineering (e.g. MSc, master’s degree or equivalent in geology, chemistry, environmental science or similar) Extensive relevant experience from process, pharma, mining or oil industry and/or global technical consulting Project management experience of complex environmental matters from technical, financial and legal aspects Experience working across multiple countries (both technical and cultural contexts) Experience engaging with regulatory authorities in more than one European jurisdiction Fluent in English and either of Swedish or Dutch Drivers license We believe you are a confident and decisive professional who can act with clarity and authority when needed. You build trust quickly, including with senior stakeholders, by communicating with credibility and sound judgement. You are skilled at building and maintaining strong relationships across functions and geographies, and you navigate complex situations with a structured and forward-looking approach. You can balance and integrate multiple perspectives—technical, legal, and financial—when making decisions, and you demonstrate strong cultural awareness when working in an international environment. At the same time, you are organized and proactive, with the ability to manage issues systematically and anticipate challenges ahead of time. We offer you At Nouryon, we provide a great job and friendly coworkers, plus benefits in addition to salary. Our collective agreement is with IKEM. Plus, we offer unilateral perks, such as bonus, reduced hours, health care allowance, lunch allowance, and more. Have we got your interest? This is a permanent position on a full-time basis, reporting to Henrik Eriksson, Global Environmental Liability Manager and based in Sweden, Gothenburg at our Nordic Business Center or in The Netherlands Amsterdam. Please apply via our online recruitment system. We will not accept applications via e-mail. Once it's with us we will review to see if we have a match between your skills and the role! For more information about our hiring process, visit: nouryon.com/careers/how-we-hire/ As an applicant, you will be subject to a background check before employment. You will receive more information about this later in the recruitment process. We work actively and systematically with HSE matters to ensure a safe and sustainable working environment for our employees. As an employee, you may therefore be required to undergo drug testing on a random basis. This is part of our commitment to safeguarding the safety and well-being of our staff. We look forward to receiving your application! About Nouryon Explore careers and life at Nouryon If you’re looking for your next career move, apply today and join Nouryon’s worldwide team in providing essential solutions that our customers use to manufacture everyday products such as personal care, cleaning, paints and coatings, agriculture and food, pharmaceuticals, and building products. Our employees are driven by the wish to make an impact and actively drive positive change. If that describes you, we will gladly make way for your ambitions. From day one we support you with your personal growth, through challenging positions and comprehensive learning and development opportunities, in a dynamic, international, diverse, and proactive working environment. Visit our website and follow us on LinkedIn. Contact For additional information about the vacancy please contact hiring manager Henrik Eriksson, Global Environmental Liability Manager at henrik.eriksson1@nouryon.com If you have any questions about the recruitment process or your application or need assistance, please contact: Recruiting.SE@Nouryon.com For union contacts, please see below: Akademikerklubben: Katarina Risö – katarina.riso@nouryon.com Unionen: Helene Rosenlund helene.rosenlund@nouryon.com Ledarna: Sanna Backman – sanna.backman@nouryon.com #WeAreNouryon #GrowWithUs We have already chosen our sourcing channels for this recruitment and kindly ask not to be contacted by any advertisement agents, recruitment agencies or staffing companies.

Join CTC - where ambition is high and one of the goals is to strengthen the Swedish infrastructure in the Life Sciences! We are growing and are now looking for an additional Medical Writer who wants to contribute to CTC’s continued journey. Are you an experienced Medical Writer (MW) who wants to use your expertise to drive CTC’s development? Then this is the opportunity for you! As a Medical Writer at CTC, you will be part of a team of four other MWs responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports. The work alternates between individual tasks and teamwork. You will be part of various study-specific project teams responsible for initiating and managing clinical projects until the delivery of study results. These cross-functional project teams include professionals such as project managers, medical and scientific advisors, research nurses, doctors, statisticians, and more. Main responsibilities: To write clinical study protocols and clinical study reports in accordance with ICH E6, ICH E3, and/or ISO 14155, and coordinate the development and quality control processes of these documents, both internally and with our clients. To write other regulatory documents and texts such as summary of results, narratives, substantial amendments and responses to authorities. To coordinate and lead meetings, both internally and externally, and act as a point of contact for clients. To serve as a mentor to colleagues. Other tasks such as medical coding, writing abstracts and scientific articles, writing assignments related to safety reporting, and writing marketing documents may also be required. We are looking for a driven and experienced Medical Writer who truly enjoys writing and formulating scientific texts. To succeed in this role, you need to have the ability to quickly and efficiently interpret, summarize, and present large amounts of data. We require you to have at least 3 years of experience in medical writing, drug development, and clinical trials. Previous experience in consultancy work and an understanding of the customer perspective are also valued. As a person, you are communicative and enjoy collaborating with experts in various fields. You are flexible, works independently, and deliver within agreed timelines. CTC’s core values: Innovation, Community, Respect, Commitment, and Professionalism resonate with you. Required qualifications MSc in the life sciences field. At least 3 years of experience in medical writing, drug development, and clinical trials. Experience in leading meetings and coordinating complex and parallel deliveries within agreed timelines. Proficiency in using the Microsoft Office suite, especially Microsoft Word. Excellent ability to express yourself grammatically correctly and clearly in English, both spoken and written. Good knowledge of the Swedish language (spoken and written). Preferred qualifications A PhD in the life sciences field. Experience with Phase 2-3 trials. Experience with medical devices and/or advanced therapy medicinal products (ATMP), as well as knowledge of regulatory requirements related to these areas. Experience in writing eCTD module 2; Clinical and Non-Clinical overview/summary, Investigator’s Brochures (IBs), Annual Safety Reports (ASRs). At CTC, you will be covered by a collective agreement and offered benefits such as flexible working hours, wellness allowance, and generous vacation terms. You will have the opportunity to work in a knowledge-intensive environment in a company with short decision-making paths, with good professional development opportunities. The position is located at our office in Uppsala (hybrid work is possible). Full time (40 hours per week). If you have questions, contact Marit Wangheim (Director Medical Writing) marit.wangheim@ctc-ab.se Please submit your application no later than 17 August 2026. CTC Clinical Trial Consultants AB is a Clinical Research Organization (CRO) with operations in Uppsala, Stockholm, Linköping, and Gothenburg. As a CRO, we conduct clinical trials and investigations on behalf of the pharmaceutical and medtech industry and academic institutions. We offer a comprehensive full-service solution that includes all the services, activities, and deliverables required to successfully conduct a clinical trial— bringing new pharmaceuticals and products to patients. We currently conduct clinical studies across all phases of development, from Phase 0 through Phase IV. Most of our studies are carried out at our own research clinics, although we also collaborate with external clinical sites. We employ approximately 125 people, around half of whom work in clinical roles. Our headquarters are located in Uppsala.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North America. The role leads the planning, development, review, and implementation of scientific materials and educational programs that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific information. Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives, and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned with organizational priorities and compliant with applicable policies and regulatory requirements. Essential Functions: * Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical congresses for U.S. Medical Affairs. * Provide content and editorial support for regional publications and scientific presentations. * Ensure regional publication priorities are represented in the global publication plan and support localization of global publication activities to meet regional needs. * Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with regional medical strategy. * Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific communications deliverables. * Support external expert engagement and steering committee activities, including coordination of content review and approval workflows. * Support scientific and medical operations, including advisory board planning and execution, medical information initiatives, and Medical Science Liaison (MSL) training. * Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed, ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced. * Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards. * Perform additional duties and special projects as assigned. Job Requirements: Education Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD, PhD, DNP, or equivalent) required.  Experience * Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or Scientific Communications. * Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions. * Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory boards, scientific symposia, medical education programs, publications, and congress deliverables. * Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and vendors to deliver high-quality scientific materials. * Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical development and medical congresses. * Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology environment. * Rare Disease experience is strongly preferred. Technical Skills * Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements. * Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information to diverse internal and external audiences and facilitate cross-functional collaboration. * Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint. * Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting scientific content development, review, approval, and distribution. * Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate complex scientific information into clear, accurate, audience-appropriate materials. * Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements. * Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines. Non-Technical Skills Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a fast-paced environment.  Strong written and oral communication skills.  Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities.  Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.  Self-starter.  Must possess integrity and be innovative in how they work on a day-by-day basis.  Has a passion for personal learning and development to be able to grow with the company.  Cultural sensitivity and ability to develop consensus within a multinational organization.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional weekend travel may be required.   The anticipated salary for this position will be $180,000 to $196,900.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The North America Head of Scientific Communications is a senior leadership role within NA Medical Affairs responsible for setting the strategic direction, oversight, and governance of scientific communications across the regional portfolio. This role ensures the delivery of high-quality, compliant, and impactful scientific communications that support evidence dissemination, medical education, and scientific exchange throughout the product lifecycle. The role provides leadership for regional publication strategy and execution, field medical resources, medical education content, digital scientific communications, congress activities, and regional medical review processes. The role leads and develops a high-performing scientific communications team and serves as a key strategic partner to Medical Affairs therapeutic area leaders, commercial team and cross-functional stakeholders. As a catalyst for innovation, the NA Head of Scientific Communications continuously evaluates emerging digital channels, data-driven insights, and evolving stakeholder engagement preferences to ensure Medical Affairs remains at the forefront of scientific exchange. This includes leveraging modern communication platforms and formats—including social media, podcasts, and other digital channels—to meet the evolving information needs of healthcare professionals, scientific experts, and key opinion leaders. Essential Functions: Future Pipeline Expansion & Capability Building * Proactively prepare NA Scientific Communications to support future pipeline expansion, including new therapeutic areas, indications, modalities, and lifecycle stages. * Anticipate scientific communications needs associated with pipeline progress and evolving portfolio complexity, including early asset planning, launch readiness, and post-launch evidence dissemination. * Design scalable scientific communications approaches, processes, and resourcing models that can flex with portfolio expansion. * Partner with Global Medical Affairs and Clinical Development to ensure early alignment of scientific narratives, data generation plans, and publication strategy for pipeline assets. * Identify capability gaps and lead continuous improvement initiatives across scientific communications, including talent development, vendor partnerships, and operational excellence.  Strategic Leadership & Governance * Develop and own the regional scientific communications strategy across multiple products, aligned with global medical strategy, portfolio priorities, and North America Medical Affairs objectives. * Establish and maintain regional governance frameworks, standards, and best practices for scientific communications across channels and formats. * Serve as a senior scientific communications advisor to North America Medical Affairs leadership and therapeutic area leads. * Ensure compliance with internal SOPs, Good Publication Practice (GPP), ICMJE guidelines, and all applicable regulatory, legal, and compliance requirements.  Publications & Evidence Dissemination * Oversee regional publication planning and execution, including abstracts, manuscripts, posters, oral presentations, and plain language summaries. * Ensure timely, high-quality execution of regional publication plans in collaboration with global partners, investigators, and external authors. * Provide strategic oversight of publication vendors and agencies, including scope, budgeting, and performance management.  Scientific Content & Medical Materials * Lead development and lifecycle management of regional scientific narratives, lexicons, and key data-driven messages. * Oversee creation, approval, and maintenance of regional field medical materials, including slide decks, FAQs, disease education materials, and data summaries. * Ensure all materials are scientifically accurate, strategically aligned, audience-appropriate, and tailored to regional needs.  Medical Education & Congress * Oversee scientific content for regional medical education, insight generation initiatives, advisory boards, and peer-to-peer scientific exchange. * Provide scientific communications leadership for regional congress strategy and execution, including content development, scientific booth materials, and symposia support. * Partner closely with Field Medical and Medical Education teams to align content with scientific objectives and stakeholder insights. Digital Scientific Communications * Provide strategic oversight of regional digital scientific assets, including modular and omnichannel-ready content, congress digital materials, and online educational resources. * Partner with digital and omnichannel teams to ensure scientific rigor, consistency, and effective data visualization across platforms.  Medical Review & Compliance Oversight * Lead and oversee regional medical review processes to ensure efficient, compliant, and high-quality review of scientific communications materials. * Serve as a senior medical/scientific reviewer and escalation point for complex scientific, regulatory, or compliance-related issues. * Drive continuous improvement of review workflows and cross-functional collaboration.  People Leadership & Talent Development * Lead, coach, and develop a team of scientific communications professionals, fostering a culture of scientific excellence, accountability, and collaboration. * Set clear objectives, provide ongoing performance feedback, and support professional development for direct reports. * Build and sustain a high-performing scientific communications function capable of supporting a growing and evolving portfolio. * Anticipate future portfolio and pipeline needs to inform thoughtful expansion of the scientific communications team over time. * Define future role profiles and succession plans to ensure the organization scales effectively as new assets and therapeutic areas are added to the portfolio.  Decision-Making Authority * Accountable for regional scientific communications strategy, priorities, and execution across the North America portfolio. * Final scientific approval authority for regional scientific communications materials within established governance and SOPs. * Authority to manage external vendors and agency partners. * Escalation authority for complex scientific, compliance, or reputational risk issues related to scientific communications. Strategic Partnerships & Cross-Functional Leadership * Serve as a strategic partner to North America Medical Affairs Leadership, Therapeutic Area Heads, Field Medical, Global Medical Affairs, and Global Scientific Communications to ensure alignment of scientific communication strategies and execution. * Collaborate closely with Clinical Development, HEOR, Regulatory Affairs, Legal, Compliance, Commercial, Digital, Omnichannel, and Alliance partners to develop and deliver impactful, compliant scientific communications and medical education initiatives. * Represent North America Scientific Communications on cross-functional governance committees, leadership forums, and strategic initiatives, providing scientific communications expertise and influencing organizational priorities. * Foster strong alignment between regional and global scientific communications strategies, ensuring consistency, operational excellence, and effective dissemination of scientific evidence across the product lifecycle. * Build and maintain productive relationships with external stakeholders, including investigators, scientific authors, vendors, and agency partners, to support high-quality scientific communication deliverables. Subordinates: Medical Communication Directors (2) and Senior Manager, PRC/MRC Job Requirements: Education Advanced Scientific or Clinical Degree: An earned Ph.D., Pharm.D., or M.D. in a relevant life sciences, biomedical, or clinical discipline is strictly required. Experience * Minimum 12+ years of experience in Medical Affairs, or related roles within pharmaceutical or biotechnology organizations, at least 6 years in Scientific/Medical Communication. * Senior leadership experience managing scientific communications teams and leading complex, cross-functional, matrixed initiatives at regional or global scale. * Extensive oversight of end-to-end scientific communications activities, including publications, medical education, field medical materials, congress strategy, and digital scientific content. * Strong understanding of publication planning standards, medical governance, and regulatory and compliance requirements within a highly regulated environment. * Experience serving as a strategic partner to Medical Affairs leadership, with ability to influence cross-functional stakeholders and align scientific communication strategies with enterprise objectives. * Background contributing to transformation initiatives in Medical Affairs, including modernization of scientific communications and evolution toward digital and omnichannel engagement models. * History of building, leading, and developing high-performing, multidisciplinary teams, including mentorship of managers and senior scientific communications professionals. * Experience operating within global or regional matrix organizations, ensuring alignment between regional execution and global scientific communications strategy.   Technical Skills & Competencies * Deep understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle, including its interface with Clinical Development, Regulatory, and Commercial functions. * Strong expertise in strategic planning, portfolio prioritization, and resource allocation within complex, global matrix organizations. * Comprehensive knowledge of Medical Affairs planning and execution, including scientific communications, publication planning, medical education, field medical strategy, evidence generation, and investigator-sponsored research activities. * Solid understanding of clinical development processes, regulatory requirements, compliance standards, and industry guidelines governing Medical Affairs operations. * Experience establishing and optimizing governance frameworks, operational processes, and performance metrics that enhance effectiveness, consistency, and scalability of Medical Affairs activities. * Ability to influence and align senior stakeholders across global and regional organizations without direct authority, driving consensus in highly matrixed environments. * Strong strategic acumen and business orientation, with the ability to translate enterprise priorities into actionable plans, clear governance structures, and measurable outcomes. * Advanced communication and executive presentation skills, with the ability to engage senior leadership and support informed, cross-functional decision-making. * Strong analytical capability, leveraging data, insights, and performance indicators to support prioritization, resource decisions, and continuous improvement. * Proficiency in business planning, portfolio tracking, and collaboration tools, with strong command of Microsoft Office applications (PowerPoint, Excel, and related tools).  Non-Technical Skills Ability to thrive in a fast-paced environment while managing ambiguity effectively. Strong work ethics are required. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations. The anticipated salary for this position will be $250,000 to $286,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Executive Administrator performs and oversees all administrative related and selected operational services for the Global Head, Business Development ("GBDH"). Position requires broad understanding of corporate operations and policies. A high level of administrative and operational support and advanced computer technology experience is required. Ability to multi-task is essential. Must operate with discretion with internal and external executives and stakeholders, and exercise independent judgment and initiative.  Key Responsibilities:   * Works directly with C-level executives and other senior leaders; serves as a liaison for the Executive Committee and the Board of Directors as needed for GBD-related topics performing a wide range of administrative duties of a highly responsible and confidential nature. * Collaborate closely with other administrators, business leaders and global colleagues. * Support GBD with organizing and planning complex face-to-face and virtual internal and external / partner meetings and conferences across multiple time zones and demonstrate flexibility in work schedule to participate in these meetings. * Attend GBD Leadership Team ("GBD LT") meetings, prepare and maintain meeting notes. Manage data and prepare / support preparation of presentations as needed. * Exhibit a positive work attitude, high productivity and a collaborative approach with employees across an international environment. * Compose correspondence on behalf of GBDH from minimal information or written draft, utilizing tactful command of proper business writing and grammar; proof-read documents and presentations. * Coordinate and utilize travel procedures to complete domestic and international travel, process travel and expense reimbursement in a timely manner. * Comply with policies and procedures and manage the purchase order and requisition process related to supporting duties. * Suggest and drive improvement processes when applicable. * Support additional ad hoc assignments as requested   Qualifications: Education * A High School Diploma or GED required. * Business school, associate's degree or equivalent is a plus. Experience * A minimum of 8 years in a corporate environment; with pharmaceutical experience preferred. Technical Skills * Manage documents effectively from and to various software programs demonstrating a comfort level with various technologies and quickly learn technologies as necessary. * Proficient in MS Office Suite (MS Word, Excel, PowerPoint), Travel and Expense systems (e.g., Concur), and other relevant software. Non-Technical Skills * Executive-level communication skills (verbal and written); high discretion and professionalism in handling confidential matters; strong interpersonal skills and stakeholder relationship management. * Advanced organizational and multitasking capabilities; exceptional attention to detail and accuracy; effective prioritization and deadline management; sound judgment and decision-making ability. * Strong problem-solving skills and adaptability in ambiguous situations; flexibility and resilience in fast-paced, high-growth environments; proven ability to influence, collaborate, and drive consensus across global, multicultural teams. * Strong work ethic with accountability and consistent follow-through; proactive mindset with commitment to continuous learning and development The anticipated salary for this position will be $83,000 to $105,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support.  They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment. Essential Functions: •    Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives. •    Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards. •    Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations. •    Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions. •    Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting. Additional activities may include, but are not limited to: •    IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track. •    Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints. •    SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness. •    Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines. Requirements: Education Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required Experience At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements;  Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics Technical Skills Proficient in MS Office Suite. Working Conditions: Requires up to 10% domestic and international travel The anticipated salary for this position will be $121,000 to $156,800.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs. Essential Functions: •    Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value. •    Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture. •    Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders. •    Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects. •    Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution. •    Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables. •    Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution. •    Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes. •    Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate. •    Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs. •    Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions. •    Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization. •    Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements. •    Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives. •    Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function. •    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision. Requirements: Education Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.  Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education. Experience •    Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.  •    Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs) •    Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval) •    Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations •    Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations •    Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D. Technical Skills •    Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management •    Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations •    Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS) •    Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions •    Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness •    Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance •    Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously. •    Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making. •    Strong proficiency MS Office Suite. Working Conditions: Requires up to domestic and international travel. The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton