Regulatory Writing Sr Mgr
Amgen · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior manager-level regulatory writing position leading complex product submission activities, including authoring and overseeing clinical documents for drug and biologics applications. The role involves directing writing teams, mentoring junior staff, and serving as functional lead on cross-functional product teams. Requires advanced degree plus relevant regulatory writing experience in biotech or pharma.
What they're looking for
- Doctorate degree with 2+ years directly related experience, or Master's degree with 6+ years
- Bachelor's degree with 8+ years experience, or Associate's degree with 10+ years
- High school diploma/GED with 12+ years directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+ years medical writing experience in Biotech/Pharmaceutical industry
What you'll be doing
- Author or oversee authoring of regulatory submission documents including Clinical Study Reports, Investigator Brochures, Protocols, and eCTD Module 2 Clinical Summary Documents
- Conduct formal review and approval of authored documents following standard operating procedures
- Lead regulatory writing activities for complex product submissions including new and supplemental applications
- Serve as functional area lead on product teams and provide input for Global Regulatory Plans
- Supervise contract and freelance writers, mentor junior medical writers, and lead departmental initiatives
Privacy & handoff
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