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