Lead Clinical Documentation Specialist

2 days ago


Gurgaon, Haryana, India beBeeMedicalWriting Full time US$ 1,26,490 - US$ 1,73,654
Key Medical Writing Roles

Synergize medical writing expertise to drive clear and accurate clinical deliverables.

  • Coordinate medical writing tasks across departments, collaborating with minimal supervision.
  • Pursue a variety of documentation including protocols, reports, informed consents, safety updates, development plans, IND submissions, summary reports, journal manuscripts, abstracts, and presentations.
  • Maintain regulatory standards according to ICH E3 guidelines, company SOPs, client requirements, approved templates, authorship criteria, and style guides.
  • Manage quality reviews, source documentation, and ensure editorial consistency.
  • Peer review documents within the team for scientific content, clarity, format, and overall coherence.

To excel in this role, candidates must possess a Bachelor's degree in a relevant field, 3-5 years of experience in science, technical, or medical writing, and a strong understanding of FDA and ICH regulations, good publication practices, and related guidelines.



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