Simplifying Complex Information for Medical Excellence

3 days ago


Gurgaon, Haryana, India beBeeMedical Full time ₹ 13,62,400 - ₹ 2,01,12,000
Medical Writer Opportunity

As a seasoned medical writer, you will play a vital role in crafting high-quality documents that meet regulatory standards.

Key Responsibilities:
  • Lead the creation of accurate and clear medical writing deliverables, ensuring scientific information is presented effectively.
  • Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision.
  • Develop a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings.
  • Ensure adherence to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides.
  • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
  • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Requirements:
  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
  • Experience writing relevant document types required.
  • Extensive knowledge of English grammar and ability to communicate clearly, strong familiarity with AMA Manual of Style.
About the Role:

This position offers an excellent opportunity to utilize your expertise in medical writing to drive success in a dynamic environment.



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