Senior Medical Writer

Location: East Coast or West Coast (Hybrid- 3 days/week onsite)

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.

• Independently author and edit regulatory documents, including:
• 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
  .

• Advanced degree in Life Sciences (Ph.D., M.D., Pharm
  
  D 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
  .

• 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