Regulatory Document Specialist

7 days ago

Remote, India beBeeMedicalWriter Full time
Medical Writer II Job Description

We are seeking an experienced Medical Writer to join our team in a key role that involves compiling, writing, and editing medical writing deliverables to ensure scientific information is presented clearly and accurately.

  • About the Role:
  • Compile, write, and edit a variety of medical writing deliverables including clinical study protocols, clinical study reports, patient narratives, investigator brochures, and periodic safety update reports.
  • Perform quality control of regulatory documents, adhering to established regulatory standards and company SOPs.
  • Coordinate quality and editorial reviews to ensure scientific content, clarity, and overall consistency.
  • Act as a peer reviewer to ensure proper formatting and scientific accuracy.

Key Responsibilities:

  • Quality Control & Compliance:
  • Perform quality control of regulatory documents, including protocols, CSRs, and IBs.
  • Adhere to established regulatory standards, such as ICH E3 guidelines, and company SOPs.
  • Coordinate quality and editorial reviews to ensure scientific content, clarity, and overall consistency.
  • Act as a peer reviewer to ensure proper formatting and scientific accuracy.

Content Creation & Documentation:

  • Compile, write, and edit a wide range of documents, including clinical study protocols, clinical study reports, patient narratives, investigator brochures, and periodic safety update reports.
  • Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency.

Collaboration & Project Management:

  • Lead document reviews, resolve comments from clients, and ensure appropriate management of source documentation.
  • Interact and build good working relationships with clients, department heads, and peers.
  • Identify and propose solutions to resolve document issues, escalating as needed.

Mentorship & Professional Development:

  • Mentor less-experienced medical writers on projects as needed.
  • Maintain a strong working knowledge of the drug development process, regulatory guidelines, and best practices.
  • Perform online clinical literature searches and comply with copyright requirements.

Requirements:

  • A Bachelor's degree in a relevant discipline with a graduate degree preferred.
  • Professional experience in science, technical, or medical writing.
  • Experience in QC of regulatory documents is a must.
  • Experience working in the biopharmaceutical, device, or contract research organization industry is preferred.
  • Familiarity with FDA and ICH regulations and AMA Manual of Style.
  • Extensive knowledge of English grammar and the ability to communicate clearly.

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