Regulatory Writing Senior Manager
Job Summary
Leading regulatory writing activities for complex product submissions, the full-time remote Regulatory Writing Senior Manager will author and oversee regulatory submission documents, mentor junior writers, and serve as the functional area lead on product teams.
Key responsibilities
- Author or oversee the authoring of all regulatory submission documents, including Clinical Study Reports and Investigator Brochures
- Conduct formal reviews and approvals of authored documents in accordance with standard operating procedures
- Lead regulatory writing activities for new and supplemental drug applications/biologics license applications with limited supervision
Required qualifications
- Doctorate degree with 2 years of directly related experience, or a Master's degree with 6 years, or a Bachelor's degree with 8 years, or an Associate's degree with 10 years, or a high school diploma/GED with 12 years of directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area
- 5+ years of experience in medical writing within the Biotech/Pharmaceutical industry
Complete Job Description
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