Senior Medical Content Specialist

2 days ago


Remote, India beBeeMedicalWriter Full time ₹ 1,04,000 - ₹ 1,30,878

Job Description

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  • Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately.
  • Works as a medical writer within and across departments with minimal or moderate supervision.
  • Completes various documents including clinical study protocols, reports, patient narratives, annual reports, and more.
  • Adheres to established regulatory standards, ICH E3 guidelines, company SOPs, client standards, and approved-templates.
  • Coordinates quality and editorial reviews, ensures source documentation is managed appropriately, and resolves comments from clients.
  • Serves as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and grammar.
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Requirements

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  • Bachelor's degree in a relevant field with relevant writing experience; graduate degree preferred.
  • At least 2 years of relevant experience in science, technical, or medical writing.
  • Experience working in the biopharmaceutical, device, or contract research organization industry preferred.
  • Familiarity with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred.
  • Ability to write relevant document types and possess extensive knowledge of English grammar.
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Benefits

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  • Interacts and builds good working relations with clients, department heads, and peers.
  • Performs online clinical literature searches and complies with copyright requirements.
  • Mentors less experienced medical writers on projects.
  • Maintains a strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices.
  • Aware of budget specifications for assigned projects.
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Additional Responsibilities

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  • Performs other work-related duties as assigned.
  • Complies with copyright requirements.
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