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Writing & Translation 4d ago

Senior Manager, Medical Writing

United StatesUnited States
Full-time
$160,000 - $180,000 / year
Senior

Job Description

Key Skills Required

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Technical WriterContent WriterMedical WritingBiotechRegulatory Documents

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About the Role: Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics. We are seeking an experienced and motivated Senior Manager, Medical Writing to provide clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents.

What You'll Do

  • Prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including protocols, investigator’s brochures, and clinical study reports.
  • Communicate deliverables needed, writing processes, and timelines, holding team members accountable to agreed-upon document milestones.
  • Ensure compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing.
  • Oversee the execution of medical writing projects by external vendors and consultants to ensure milestones are met.
  • Leverage AI-enabled tools to enhance the efficiency and quality of medical writing deliverables.

What You Bring

  • Bachelor's degree in science (advanced degree is a plus) with 8+ years of experience in medical writing in the pharmaceutical or biotech industry.
  • Ability to understand, critically analyze, and interpret data to summarize complex results in an unambiguous and concise manner.
  • Experience independently authoring a range of scientific documents and overseeing authoring by third parties.
  • Detail-oriented with exceptional organizational and project management skills.
  • Proficiency in scientific writing tools (e.g., Microsoft Office suite, document management systems, reference management software).

Benefits

  • Anticipated base salary range of $160,000 - $180,000 / year, plus performance bonus and equity grant opportunities.
  • Comprehensive health, welfare, and retirement benefits.
  • Competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year, and dedicated paid sick leave.
  • 100% remote work environment with regular all-team, in-person meetings.

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