Regulatory Writing Sr Mgr

Job Description Regulatory Writing Senior Manager - Live What You Will Do Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications and biologics license applications Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Supervise the work of contract and freelance writers and mentor junior medical writers as assigned Lead departmental and cross‑departmental initiatives, as appropriate Generate document timelines What We Expect Of You Basic Qualifications Doctorate degree and 2 years of directly related experience Masters degree and 6 years of directly related experience Bachelors degree and 8 years of directly related experience Associate’s degree and 10 years of directly related experience High‑school diploma / GED and 12 years of directly related experience Preferred Qualifications Experience with regulatory documents in Regulatory Affairs, Research, Development or related area 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry What You Can Expect Of Us Our Total Rewards Plan includes comprehensive benefits and opportunities for growth. Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program; field sales representatives receive a sales‑based incentive plan Stock‑based long‑term incentives Award‑winning time‑off plans and bi‑annual company‑wide shutdowns Flexible work models, including remote work arrangements where possible Amgen 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. We will ensure that individuals with disabilities are provided 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 accommodation. #J-18808-Ljbffr BioSpace