{"id":2893857,"url":"https://alion.io/job/biogen-senior-pms-lead","title":"Senior PMS Lead","company":{"id":449685,"name":"Biogen","domain":"biogen.com","url":"https://alion.io/company/biogen-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":18,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":45000,"max_usd":114000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2403},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-10-20T03:53:16Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-22T02:12:19Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Scope:\nProvide strategic and operational leadership for post-marketing surveillance (PMS) activities for assigned products and programs in Japan.\nLead PMS strategy, study planning, execution oversight, and quality oversight in compliance with GPSP regulations.\nAuthor, review, and manage PMS study reports and regulatory submission documents for assigned products.\nLead or contribute to PMS-related SOPs/WIs and continuous process improvements.\nPlan and manage resources and budgets for assigned PMS programs, and appropriately escalate key risks and trade-offs.\nLead and support inspection readiness activities for assigned PMS programs.\nServe as Deputy PMS Supervisor as needed within delegated authority.\nKey Responsibilities：\nDevelop and lead PMS strategy for assigned products and programs, aligned with RMP, benefit-risk needs, Japanese regulatory requirements, global strategy, and business priorities.\nLead 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.\nDevelop 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.\nProvide strategic oversight of data management and statistical analysis for assigned studies, including data quality, SAP review, interpretation of results, and regulatory suitability of outputs.\nAuthor 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.\nOversee execution of assigned PMS/GPSP programs to ensure quality, timelines, budget control, and compliance, intervening or escalating when commitments or delivery are at risk.\nLead outsourcing and vendor governance for assigned PMS programs.\nLead outsourcing and vendor governance for assigned GPSP activities, including contract/SOW input, performance, quality, costs, issue escalation, corrective actions, and inspection-ready documentation.\nLead or contribute to PMS-related SOPs/WIs, standardization, and continuous improvement to enhance quality, efficiency, consistency, and inspection readiness.\nLead CAPA activities for assigned PMS/GPSP programs, including root-cause review, action planning, timely closure, effectiveness checks, and escalation of systemic issues.\nLead and support PMDA inspection readiness, PV audits, and PV/GPSP inspections for assigned PMS activities, coordinating responses and completion of commitments.\nLead 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.\nEssential Skills and Qualifications Required:\nStrong knowledge of GPSP, GVP, Japanese pharmaceutical regulations, and the regulatory use of PMS evidence.\nUnderstanding of epidemiology, biostatistics, and real-world evidence, with the capability to lead study design discussions, interpret results, and translate findings into regulatory deliverables.\nProgram and vendor leadership skills, including scope, timelines, budgets, risks, quality, and corrective actions.\nStrong analytical judgment and problem-solving skills in complex or ambiguous situations.\nAbility to lead and influence cross-functional and global stakeholders without formal authority.\nAbility to ensure compliance, CAPA effectiveness, continuous improvement, and inspection readines.\nProactive and accountable leadership style, with the ability to coach and provide technical guidance.\nMinimum Education Requirements:\nBachelor's degree or above (pharmaceutical/medical/life sciences preferred).\nMinimum Experience Requirements:\n~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.\nJob Level: ManagementWhy Biogen?\nWe 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.\nAt 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.\nAll 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. 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