{"id":2319480,"url":"https://alion.io/job/amgen-global-regulatory-writing-senior-associate","title":"Global Regulatory Writing – Senior Associate","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"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":442,"ghost_share":0.002,"stale_share":0.833,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":18500,"max_usd":42000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1301},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-10-12T05:48:50Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-18T16:55:47Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Career Category\nRegulatoryJob Description\nABOUT AMGEN\nAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.\nKey Responsibilities:\nIndependently author routine to moderately complex regulatory documents, including: ICFs and ICF Amendments, PLPSs and PLPS Amendments, CSR sections (synoptic, abbreviated, and standard reports; pivotal CSRs with guidance/support), PLS, Protocol Amendments and Country-Specific Protocol Supplements, IB updates (minor/focused updates).\nManage document versions, reviewer comments, and approval workflows end-to-end for assigned documents.\nEnsure assigned documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.\nPrepare documents that are QC-ready and inspection-ready, adhering to applicable guidance documents, SOPs, and regulatory requirements.\nSupport audits and inspections by providing document history, supporting documentation, and justification/rationale as required.\nCollaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and efficiently incorporate feedback.\nParticipate in document-related meetings, as required.\nProactively escalate risks, scope changes, and timeline challenges to managers.\nTrack assigned deliverables and ensure adherence to agreed timelines.\nParticipate in internal training programs, knowledge-transfer sessions, and continuous process improvement initiatives.\nDemonstrate consistent, on-time delivery of assigned deliverables.\nCollaboration Skills\nCross-functional stakeholder management\nEffective communication and presentation skills\nNegotiation and conflict resolution\nStrategic thinking and decision-making\nOwnership and accountability\nProject Management and Operational Skills\nTimeline planning and execution\nManaging multiple deliverables simultaneously\nRisk identification and mitigation\nReview coordination and comment resolution\nProficiency in document management systems, RIM tools, SharePoint, and document authoring platforms\nBasic Qualifications:\nMaster’s degree and 5 to 8 years of directly related experience\nEQUAL OPPORTUNITY STATEMENT\nAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.\nWe will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.\n.","description_format":"text","description_chars":3011,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-12T05:48:50Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.628,"p_room":1,"age_days":6,"expected_fill_days":27,"reasons":["conf:12","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/amgen-global-regulatory-writing-senior-associate","json_url":"https://alion.io/job/amgen-global-regulatory-writing-senior-associate.json","meta":{"generated_at":"2026-10-20T02:59:09Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3265,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-global-regulatory-writing-senior-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Famgen-global-regulatory-writing-senior-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Famgen-global-regulatory-writing-senior-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/amgen-global-regulatory-writing-senior-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-global-regulatory-writing-senior-associate"}]}