Senior Medical Writer
Senior Medical Writer - Regulatory
Location: East Coast or West Coast (Onsite - 3 days/week)
Salary: $120,000 - $145,000 annual base salary
About the Role
An emerging biotech company with a transformative approach to drug discovery is seeking an experienced Senior Medical Writer to join its Regulatory Affairs team. This role is pivotal in preparing high-quality clinical and regulatory documents that support a diverse pipeline of innovative therapies. You'll collaborate with cross-functional teams to ensure clarity, accuracy, and compliance in submissions to global health authorities.
What You'll Do
- Independently author and edit regulatory documents, including:
- Clinical protocols, CSRs, Investigator Brochures (IBs)
- CTD modules (Module 2.7.x, 2.5, and integrated summaries)
- Briefing documents, manuscripts, abstracts, and other regulatory deliverables.
- Interpret scientific and clinical data for clear, concise presentation.
- Manage document lifecycle: timelines, review cycles, and quality control.
- Drive kick-off meetings, comment resolution sessions, and cross-functional alignment.
- Maintain compliance with ICH, GCP, and international regulatory guidelines.
Qualifications
- Advanced degree in Life Sciences (Ph.D., M.D., PharmD preferred) OR
Master's with 3+ years OR Bachelor's with 5+ years of relevant experience. - Proven experience in medical and regulatory writing for global submissions.
- Strong understanding of clinical development phases and regulatory processes.
- Excellent communication, project management, and organizational skills.
- Technical proficiency with Microsoft Office and document management systems (e.g., Veeva RIM, SharePoint).
- Ability to thrive in a fast-paced, collaborative environment.
Why This Opportunity Stands Out
- Join a stable and well funded, innovative biotech with a robust pipeline advancing toward late-stage development.
- Work alongside industry-leading experts in a culture that values innovation and excellence.
- Competitive compensation including bonus and equity, plus:
- 401k with company match
- Comprehensive medical, dental, and vision coverage
- Mental health and wellness benefits
- Generous PTO and holiday shutdowns
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