Principal Medical Writer - Regulatory and Medical Writing
$126,339–$160,340 year
Remote · Carlsbad, California, United States or Boston, Massachusetts, United States
Job Summary
The Principal Medical Writer will collaborate with internal teams to lead, write, and manage complex clinical regulatory documents, including clinical study reports, Investigator Brochures, protocols, and marketing application documents. This role involves leading cross-functional teams, ensuring compliance with regulations, performing quality control reviews, and mentoring junior writers. Candidates must possess a Bachelor’s degree and have a minimum of 8 years of relevant medical writing experience, particularly in the pharmaceutical industry. Strong knowledge of FDA and international guidelines, excellent attention to detail, and communication skills are essential.
Required Qualifications
- Bachelor’s Degree required
- A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry.
- Marketing application experience (e.g., lead writer of Module 2.5, 2.7.3, or 2.7.4) required.
- In depth experience writing Safety sections of regulatory documents preferred.
- Extensive working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6.
- Strong ability to assimilate and analytically interpret scientific data.
Desired Qualifications
- Advanced degree in a relevant scientific/clinical/regulatory field.
- Experience as lead writer of key documents included in major US and/or international regulatory submissions.
- Mentoring junior writers.
Additional Requirements
- NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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