Sr. Medical Writer

2 days ago Be among the first 25 applicants

Are you an experienced Medical Writer passionate about delivering high-quality clinical and regulatory documentation? Join our growing team and play a key role in driving excellence in medical and scientific communications that support global drug development programs.

• Draft and edit documents supporting clinical studies — including protocols, amendments, informed consent forms, and clinical study reports (CSRs).
• Develop and review aggregate safety and efficacy reports (IBs, PBRERs, DSURs, etc.).
• Prepare and manage regulatory submissions
  , including briefing books and eCTD Module 2/5 clinical summaries
  .
• Manage timelines, meetings, and document reviews across cross-functional study teams
  .
• Represent Global Medical Writing at cross-functional meetings and collaborate closely with clinical, regulatory, and biostatistics teams.
• Provide peer review, editing, and process improvement support to ensure consistency and quality across documentation.

• Bachelor’s degree or higher (scientific background preferred).
• 6+ years of medical writing experience in the pharmaceutical/biotech industry (or 10+ years in medical/scientific writing roles).
• Strong understanding of drug development
  , clinical study design
  , and regulatory documentation
  .
• Experience writing protocols, CSRs, INDs, BLAs/NDAs, PBRERs, and DSURs
  .
• Familiarity with AMA, CBE, and Chicago style guides and medical dictionaries (MedDRA, WHO Drug).
• Skilled in Microsoft Office
  , document management systems (Veeva, SharePoint, Live Link), and data interpretation (tables, figures, and clinical data presentations).
• Excellent project management, communication, and leadership skills.

This is an exciting opportunity to shape medical writing excellence, streamline global documentation, and collaborate across multidisciplinary teams in a fast-paced, mission-driven environment.

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Apply now or DM me for more details!

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