Regulatory Writing Senior Manager
$139.58k - $188.85kAmgen Inc
Amgen seeks a Regulatory Writing Senior Manager to lead regulatory submission activities for pharmaceutical and biologics products. The role involves authoring complex regulatory documents, mentoring junior writers, and serving as functional area lead on cross-functional product teams.
Responsibilities
- Author or oversee authoring of regulatory submission documents including Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents
- Lead regulatory writing activities for complex product submissions including new and supplemental drug/biologics license applications
- Serve as functional area lead on global product teams and provide regulatory writing expertise
- Supervise and mentor contract, freelance, and junior medical writers on assigned projects
- Conduct formal review and approval of authored documents per applicable standard operating procedures
Requirements
- Doctorate degree plus 2 years directly related experience, or Master's plus 6 years, or Bachelor's plus 8 years, or equivalent
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or related field
- 5+ years medical writing experience in Biotech/Pharmaceutical industry
- Demonstrated leadership and mentoring capabilities
- Expertise in clinical submission document preparation and regulatory processes
Compensation: $139,581.90–$188,846.10 USD
Vacancy posted 13 days ago
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