Medical Writer II (QC of Regulatory Docs)

Medical Writer II

Roles & Responsibilities

• Quality Control & Compliance:

• Perform

  QC 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.
• Be aware of project budget specifications and work within the budgeted hours.

• 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.

What We're Looking For

• 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.