Principal / Senior Medical Writer
143631 Posted : 26th April 2024
- 150000 USD - 160000 USD
- Lexington, United States
- Permanent
Responsibilities
- Produce high quality and on-time medical writing deliverables.
- Lead development, including writing and project management, of clinical regulatory documents, including but not limited to clinical study protocols, investigator’s brochures, clinical study reports, safety data summaries, clinical and nonclinical components of a new IND application with some or minimal supervision.
- Collaborate with project teams on developing clinical and regulatory documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs).
Qualifications
Bachelor’s degree required; advanced degree in a relevant scientific / clinical / regulatory discipline strongly preferred.
Senior Medical Writer 5 to 6 years of relevant experience in the pharmaceutical industry and 3 years of medical writing experience Principal Medical Writer 8+ years of relevant experience in the pharmaceutical industry and 5 years of medical writing experience
- Regulatory writing experience with specific expertise in writing clinical study protocols and amendments, investigator’s brochure, clinical study reports and safety data summaries.
- Experience driving the completion of document writing from start to finish with tight timelines and through close collaboration with cross-functional study teams
- Proficient in Microsoft Word, Excel, PowerPoint, PleaseReview, SharePoint or other joint writing / editing tools
- Knowledge of requirements for preparation of regulatory documents for INDs, CTAs, NDAs / BLAs and annual reports.
- Demonstrated ability to communicate and write clearly, concisely, and effectively
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