Job Scope:
- Provide strategic and operational leadership for post-marketing surveillance (PMS) activities for assigned products and programs in Japan.
- Lead PMS strategy, study planning, execution oversight, and quality oversight in compliance with GPSP regulations.
- Author, review, and manage PMS study reports and regulatory submission documents for assigned products.
- Lead or contribute to PMS-related SOPs/WIs and continuous process improvements.
- Plan and manage resources and budgets for assigned PMS programs, and appropriately escalate key risks and trade-offs.
- Lead and support inspection readiness activities for assigned PMS programs.
- Serve as Deputy PMS Supervisor as needed within delegated authority.
Key Responsibilities：
- Develop and lead PMS strategy for assigned products and programs, aligned with RMP, benefit-risk needs, Japanese regulatory requirements, global strategy, and business priorities.
- Lead planning and design of PMS/GPSP studies, including use-results surveys, database studies, and post marketing clinical studies, covering study concept, population, data sources, endpoints, analysis approach, and regulatory use of outputs.
- Develop and/or critically review protocols, CRFs, EDC/data management requirements, statistical analysis plans, and study reports for scientific validity, data quality, operational feasibility, and regulatory suitability.
- Provide strategic oversight of data management and statistical analysis for assigned studies, including data quality, SAP review, interpretation of results, and regulatory suitability of outputs.
- Author and/or critically review PMS CSRs, study reports, J-PSURs, re-examination dossiers, and other regulatory deliverables for assigned products, and recommend the regulatory narrative and submission position.
- Oversee execution of assigned PMS/GPSP programs to ensure quality, timelines, budget control, and compliance, intervening or escalating when commitments or delivery are at risk.
- Lead outsourcing and vendor governance for assigned PMS programs.
- Lead outsourcing and vendor governance for assigned GPSP activities, including contract/SOW input, performance, quality, costs, issue escalation, corrective actions, and inspection-ready documentation.
- Lead or contribute to PMS-related SOPs/WIs, standardization, and continuous improvement to enhance quality, efficiency, consistency, and inspection readiness.
- Lead CAPA activities for assigned PMS/GPSP programs, including root-cause review, action planning, timely closure, effectiveness checks, and escalation of systemic issues.
- Lead and support PMDA inspection readiness, PV audits, and PV/GPSP inspections for assigned PMS activities, coordinating responses and completion of commitments.
- Lead cross-functional collaboration with PV, RA, Medical, Clinical, Commercial, Global teams, and vendors for assigned PMS programs; provide technical guidance and escalate material matters to the PMS functional leader.
Essential Skills and Qualifications Required:
- Strong knowledge of GPSP, GVP, Japanese pharmaceutical regulations, and the regulatory use of PMS evidence.
- Understanding of epidemiology, biostatistics, and real-world evidence, with the capability to lead study design discussions, interpret results, and translate findings into regulatory deliverables.
- Program and vendor leadership skills, including scope, timelines, budgets, risks, quality, and corrective actions.
- Strong analytical judgment and problem-solving skills in complex or ambiguous situations.
- Ability to lead and influence cross-functional and global stakeholders without formal authority.
- Ability to ensure compliance, CAPA effectiveness, continuous improvement, and inspection readines.
- Proactive and accountable leadership style, with the ability to coach and provide technical guidance.
Minimum Education Requirements:
Bachelor's degree or above (pharmaceutical/medical/life sciences preferred).
Minimum Experience Requirements:
~8+ years of PMS (GPSP) experience, including leading study planning/oversight. Hands-on experience in protocol/CRF creation and EDC/DM implementation. Played a key/leading role in re-examination application. Third-party/CRO management experience; statistical skills preferred. Experience leading a small team / developing talent is desirable.
Job Level: Management
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
