Principal Medical Writer

1 day ago


Remote, India beBeeMedical Full time
Medical Writer Role

We are seeking a skilled Medical Writer to compile, write, and edit medical documents. The ideal candidate will have expertise in writing Clinical Study Reports (CSRs) and a proven ability to mentor less experienced writers.

Job Responsibilities
  • Mentor less experienced medical writers on projects.
  • Compile, write, and edit medical writing deliverables with minimal supervision.
  • Develop or support a variety of documents, including Clinical Study Protocols, Clinical Study Reports (CSRs), Patient Narratives, and Investigator Brochures.
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, and consistency.
  • Interact with various departments to produce deliverables.
  • Serve as a peer reviewer on internal teams, ensuring document scientific content, clarity, and proper formatting.
Required Skills and Qualifications
  • Strong experience in medical writing, with a minimum of 3 years of relevant experience in Narrative writing.
  • Proven experience in independent authoring and reviewing CSR Narratives.
  • A Bachelor of Science or a Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific and/or medical knowledge.
  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines.
  • Familiarity with AMA style guide.
  • Effective presentation, proofreading, interpersonal, and leadership skills.
  • Strong proficiency in Word, Excel, PowerPoint, email, and the Internet.
  • A working knowledge of the drug development process and regulatory guidelines.


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