Regulation

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. This position requires being onsite two days a week in our Princeton, NJ HQ. This is note a remote opportunity. Summary of Job: The Senior Medical Director, Global Medical Affairs – Oncology is responsible for leading the development and execution of global medical affairs strategies for oncology programs, with a focus on myeloid malignancies. This role provides medical and scientific leadership across assigned assets and supports the integration of medical strategies with broader corporate objectives. The incumbent will lead global medical activities related to evidence generation, scientific communication, and external engagement, including collaboration with alliance partners and key external stakeholders. The position works cross-functionally with Clinical Development, Commercial, Regulatory, Market Access, and other internal teams to ensure alignment and effective execution of medical affairs initiatives. This role requires deep expertise in oncology and or hematology, strong strategic and analytical capabilities, and the ability to lead complex, cross-functional initiatives in a global environment. Essential Functions: * Lead the development and execution of global medical affairs strategies for assigned oncology assets, including pre-launch planning, lifecycle management, and long-term strategic initiatives focused on myeloid malignancies. * Serve as the primary global medical scientific lead for healthcare decision-makers and external stakeholders, facilitating scientific exchange regarding disease state management and the clinical and economic value of oncology products. * Collaborate cross-functionally with Clinical Development, Research & Development, HEOR, Market Access, Commercial, Regulatory, and other internal stakeholders to ensure alignment of medical strategies with corporate and portfolio objectives. * Lead integrated evidence generation strategies and medical data generation plans, including company-sponsored clinical trials, investigator-sponsored studies, and real-world evidence initiatives. * Provide strategic medical leadership for alliance partnerships by collaborating with partner companies to align on shared medical strategies, evidence generation activities, and external engagement plans across joint oncology programs. * Oversee the execution and quality of ongoing medical affairs studies and activities to ensure scientific rigor, compliance with regulatory requirements, and alignment with organizational objectives. * Identify evidence gaps, emerging scientific trends, and external insights to inform medical strategy, portfolio development, lifecycle planning, and stakeholder engagement activities. * Build and maintain strategic relationships with key opinion leaders (KOLs), healthcare systems, advocacy organizations, payer organizations, and other external stakeholders globally. * Represent the organization at scientific congresses, advisory boards, investigator meetings, and other external forums to communicate medical and scientific data and support organizational thought leadership in oncology. * Coordinate global medical affairs activities with alliance partners and internal stakeholders to support seamless execution of shared medical initiatives and external engagement strategies. * Provide leadership, coaching, and development for direct reports and/or junior medical affairs team members, including performance management, mentoring, and fostering a collaborative, high-performing team culture. * Supervise and manage assigned personnel, consultants, vendors, and external collaborators, as applicable, to ensure effective execution of medical affairs objectives and adherence to company policies and compliance standards. Job Requirements:  Education Medical Doctor. Board certification and/or subspecialty training in Oncology and/or Hematology preferred.  Experience * Minimum of 10 years of experience in Medical Affairs within the pharmaceutical and/or biotechnology industry, including significant experience in oncology; hematology and/or myeloid malignancy experience strongly preferred. * Combination of Global and Regional/Country Medical Affairs experience strongly preferred, including experience supporting global product strategy and execution. * Demonstrated experience developing and executing global medical affairs strategies across multiple stages of the product lifecycle, including pre-launch and post-launch activities. * Proven track record of leading cross-functional initiatives and influencing matrixed teams across Medical Affairs, Clinical Development, Commercial, HEOR, Market Access, and Regulatory functions. * Experience leading evidence generation activities, including company-sponsored studies, investigator-sponsored research, and/or real-world evidence initiatives. * Demonstrated success engaging with external stakeholders, including key opinion leaders (KOLs), healthcare decision-makers, advocacy organizations, and payer audiences in global markets. * Proven ability to collaborate effectively with alliance partners, external collaborators, and co-development/co-commercialization partners. * Strong people leadership capabilities, including mentoring, coaching, and direct management of medical affairs personnel and/or cross-functional teams. * Proven ability to represent the organization at scientific congresses, advisory boards, investigator meetings, and other external scientific forums. * Strong knowledge of HEOR disciplines, biostatistics, clinical trial design, and evidence-based medicine principles. * Exceptional interpersonal, communication, presentation, and organizational skills. * Strategic thinking with demonstrated ability to influence stakeholders across matrix environments.  Technical Skills * Strong knowledge of oncology medical affairs, including evidence generation, scientific exchange, and product lifecycle support within global markets. * Advanced understanding of HEOR disciplines, biostatistics, clinical trial design, real-world evidence, and evidence-based medicine principles. * Strong scientific acumen with the ability to interpret, analyze, and communicate complex clinical and scientific data to diverse stakeholder audiences.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work. Working Conditions: Requires up to 35% domestic and international travel The anticipated salary for this position will be $256,800 to $335,400.  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 #LI-Hybrid

Your role at Veezu: As a Dispatcher in our Journey Booking Centre, you will work in partnership with Driver Partners and our external JBC Partners to ensure bookings are dispatched efficiently so that passengers are transported on time. You will maximise Driver Partner completion rates through efficient management of the dispatch of inbound bookings and good communication with Driver Partners. Reporting into the Team Manager or JBC Manager, your role will involve optimising Driver Partner and resource capacity, helping our Off-Shore Booking Agents to keep our Passengers updated and giving the Driver Partners a great experience. Who are Veezu? Veezu is the UK's fastest growing taxi and private hire technology platform operating across hundreds of UK towns and cities. We are a tech-driven on-demand mobility service that supports our hyper-local communities, helping them thrive and so much more! What you’ll do: QUALITY DELIVERY AND CONTINUOUS IMPROVEMENT * Develop a deep knowledge and understanding of the local Driver Partner community - their needs, concerns and behaviours – become someone that they trust. * Take responsibility for understanding, meeting and exceeding your objectives and set KPIs * Allocate and dispatch journeys on the Dispatch booking system, communicating positively, politely, professionally and precisely with Driver Partners via the messaging service/telephone as and when required. * Manage passenger demand to ensure bookings run on time and use the zone controller tool and wait time wallboard (if applicable) effectively. Feedback any delays to Offshore Booking as required. * Arrange bookings for walk-in passengers where applicable at regional hubs. * Liaise with off-shore partners in respect of handling passenger queries and bookings. * Respond to Driver Partner alerts and Driver Partner queries via the telephone and / or Dispatch driver chat in a timely, courteous and professional manner. * Assist Driver Partners with complex queries or directing them to the Driver Partner portal and / or messaging service. * Demonstrate excellence in the handling of passenger bookings, mainly related to our high value and commercial account journeys and passenger care queries * Ensure specific or set instructions for account customer journey bookings are communicated and processed accordingly. * Ensure service delivery to commercial account customers is efficient and well managed at all times. * Ensure transferring of calls is kept to a minimum and avoid blind transferring at all times. * Utilise Slack channels, Dispatch messaging and any other relevant internal communication channels throughout your shift to receive any relevant business and / or operational updates. * Liaise with other departments such as Veezu Commercial, Veezu IT to ensure issues are resolved efficiently and within agreed SLAs. * Identify opportunities to reduce unnecessary contact, improve policies and processes, increase sales and/ or improve the passenger experience and feed these into your Team Manager. * Seek to support passengers, account customers and Driver Partners to self-serve wherever possible. * Process all cash, card, account, and app bookings in accordance with company procedures. * Encourage the use of AirPay / use of a Driver Partner’s in-car payment machine to reduce call time wherever possible. * Manage and keep the zone controller accurate (if applicable) and up to date throughout the shift so that the right information can be provided to Passengers and bookings can be optimised. SELF-DEVELOPMENT AND COMPLIANCE * Ensure completion of all mandatory training. * Manage your own self-development to improve knowledge. * Proactively prepare for 1:1 meetings and appraisals with Team Manager or JBC Manager. * Understand and embody the Veezu values. * Constructively challenge, question, seek to improve, evolve and be kind. * Contribute to a strong community spirit. * Be objective, fair, ethical, and consistent. * Ensure fair treatment of customers, passengers, Driver Partners and colleagues and act in a professional manner at all times. * Ensure legal and contractual compliance. * Maintain regular consistent and professional attendance, punctuality, personal appearance, and adherence to relevant health & safety procedures. * Be willing to support other business areas as needed. * Adhere to company policies and procedures. * Ensure that customer, passenger, Driver Partner and colleagues’ information is safeguarded at all times, in line with the General Data Protection Regulation (GDPR). * Be committed to maintaining our ISO27001 certification and set high standards for Information Security compliance. * Maintain information security to a recognised required standard in line with business needs What you’ll need: * Ability to deliver excellent customer service. * Confidence in speaking to people on the phone. * Strong computer skills, including using multiple software platforms collaboratively. * Excellent listening and communication skills. * Professional and committed. * Ability to deal with challenging customer service situations. * Ability to work in a fast-paced environment. * Ability to multitask and work under pressure. * Ability to work independently and as part of a team. * Flexibility to work outside of standard working hours. * Excellent accuracy and attention to detail. Where you’ll be: * This role will be based out of our Shrewsbury office. Veezu is committed to fair and inclusive recruitment, welcoming applications from all backgrounds, experiences, and communities.

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

Etraveli Group is a leading global flight technology provider, specializing in flight sales and offering flight content delivery and fintech products. We are here to solve complexity, by connecting millions of flights and travelers across the globe, from search and selection to trip and beyond. We partner with major global platforms such as Booking.com, Google Flights, Skyscanner, and Kayak, providing seamless flight booking and related services. Our B2B portfolio includes a separate fintech entity with its flagship product, PRECISION, a risk management solution, Sweden’s leading flight comparison site Flygresor.se, Tripstack, our B2B Flights as a Service Provider and world leader in virtual interlining, and Wenrix, the embedded AI platform for flights. We also operate our own online travel agency brands including Gotogate, Mytrip, and Flightnetwork. Every day we strive to make the world smaller for our customers and bigger for our people. Our diverse team of more than 3200 passionate professionals is what makes us the industry’s tech wonder and the best in the world at what we do. Major offices in Sweden (HQ), Greece, India, Canada, Israel, Poland, UK, and Uruguay. The Team: Platform Services At the heart of this technology is the Platform Services team, a highly technical group responsible for maintaining and evolving the foundational aspects of the Etraveli Group platform. Our mission is to ensure we have a robust environment to build, deliver, and run services—from the very first lines of code in a project to maintainable services running in production, whether in AWS or our own datacenters. We manage our CI/CD setup and cloud infrastructure using Infrastructure as Code (IaC), providing project templates and architectural support to development teams and strategically important projects. Today, the team consists of a collaborative mix of cloud infrastructure specialists and tech-focused senior developers. The Role As we grow and expand our support for new teams and projects, we are looking for a Senior Engineer or Hands-on Architect to strengthen our ranks. While the team handles infrastructure, your focus will be on the software side of building services: code, design, system architecture, and CI/CD. In this role, you will certainly draw boxes and arrows on whiteboards to map out designs, but more importantly, you will write and update the code within our templates and CI/CD pipelines to support our developers. You will be a key voice in discussions—both within the team and across the organization—on how to best design and solve complex technical tasks. Requirements To be a good fit for this role, we believe you possess the following qualifications: Experience: At least 10 years as a software developer and/or architect (likely more). Java Expertise: Extensive experience as a Java backend developer, very comfortable in a senior capacity. Polyglot Mindset: Experience with programming languages beyond just Java. Mentorship: You enjoy supporting other developers and can discuss complex software solutions with both teams and stakeholders. CI/CD & Kubernetes: At least some experience with CI/CD (and a willingness to become an expert) and a strong understanding of Kubernetes—including the ability to write and troubleshoot manifest files independently. Broad Technical Interest: An interest in the underlying infrastructure required to run services, as well as a passion for service architecture and IaC (without being "married" to a single tool). Tech Stack Knowledge: Meaningful experience in several of the following: AWS, Linux, shell scripting, Git, Jenkins, Groovy, Typescript, React, Python, MySQL, Couchbase, Kafka, RabbitMQ, Terraform, CDK, CloudFormation, Gradle, Spring Boot, Kubernetes, Helm, OpenSearch, Prometheus, Grafana, observability, security, networking, and testing. Communication: Comfortable speaking and writing in English. Ready to take off from day #1 Thorough On Boarding Process We are building a stellar onboarding adventure just for you, spanning your first 120 days, including access to learning resources, Q&A sessions with our CEO and a buddy program. Competitive Benefits We pay fairly and align compensation with your role's impact on the company. Referral bonus, pension and insurances are also applicable, with some variations across our locations. Wellbeing & Community In order to be the best version of you every day, you need an environment that provides for your wellbeing. From breakfast & good coffee to start your day to healthcare, employee assistance plans and team bonding events we've got you covered! Opportunities for Development You will find extensive learning opportunities, team training and workshops connected to your role as well as guidance from renown leaders, all provided in a fast pace environment with flat hierarchies. Hybrid Work We want you to enjoy the best of all worlds and we know that doesn't always mean working at the office. We have a hybrid policy, including working from anywhere 2 weeks every year. Diversity disclaimer At Etraveli Group we value diversity; we pride ourselves on being a company represented by people of all different backgrounds. During hiring, we are committed to ensure equality and promote diversity in the workplace at every selection stage. As such, we provide the same opportunities for all candidates regardless of race, religion or belief, gender, nationality, ethnicity, sexual orientation, age, marital status, disability, or any other characteristic protected under any anti-discrimination law or regulation.