Medical Writer II (Narrative Writing)

Medical Writer II

Roles & Responsibilities

• Core Writing & Documentation:

• Compile, write, edit, and coordinate a wide range of medical writing deliverables with a primary focus on

  CSR safety narratives

  (authoring, addressing review comments, and collaborating with teams).
• Complete documents such as

  clinical study protocols

  ,

  clinical study reports

  , patient narratives, investigator brochures, and periodic safety update reports.
• Review

  statistical analysis plans

  and table/figure/listing specifications to ensure content and formatting are consistent and appropriate.

• Compliance & Quality Control:

• Adhere to established regulatory standards, including

  ICH E3 guidelines

  , and internal SOPs.
• Coordinate

  quality and editorial reviews

  and act as a

  peer reviewer

  for the internal team.
• Lead document reviews and resolve comments from clients to ensure the final deliverable meets all requirements.

• Collaboration & Project Management:

• Build and maintain good working relationships with clients, department heads, and peers to produce high-quality deliverables.
• Identify and propose solutions to resolve document-related issues, escalating as needed.
• Stay aware of project budget specifications and manage work within the allocated hours.

• Mentorship & Professional Development:

• Mentor less-experienced medical writers on projects as necessary.
• Maintain a strong working knowledge of the

  drug development process

  , regulatory guidelines, and industry standards.
• Perform online clinical literature searches and comply with copyright requirements.

Qualifications

• A Bachelor's degree in a relevant discipline with a graduate degree preferred.
• At least professional experience in science, technical, or medical writing.
• Experience in the

  biopharmaceutical, device, or contract research organization industry

  is a plus.
• Familiarity with

  FDA and ICH regulations

  and

  AMA Manual of Style

  .
• Extensive knowledge of

  English grammar

  and the ability to communicate clearly.