Medical Writer II (CSR Safety Narratives)

Medical Writer II

Roles & Responsibilities

• Core Writing & Documentation:

• Compile, write, edit, and coordinate a variety of medical writing deliverables.
• Primary focus on

  CSR safety narratives

  (authoring, addressing review comments, and collaborating with teams).
• Complete various documents, including clinical study protocols, clinical study reports, patient narratives, investigator brochures, and abstracts/posters for scientific meetings.

• Compliance & Quality Control:

• Adhere to established regulatory standards, such as

  ICH E3 guidelines

  , and company SOPs.
• Coordinate quality and editorial reviews to ensure scientific content, clarity, and consistency.
• Act as a

  peer reviewer

  for the internal team.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content and consistency.

• Collaboration & Project Management:

• Lead document reviews, resolve comments from clients, and ensure source documentation is managed appropriately.
• Interact and build strong working relationships with clients, department heads, and peers.
• Identify and propose solutions for document issues, escalating as needed.
• Be aware of project budget specifications and work within budgeted hours.

• Mentorship & Professional Development:

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

Preferred Candidate Profile

• A strong background in

  drafting CSR safety narratives

  .
• Experience collaborating with cross-functional teams and addressing review comments.
• A solid understanding of regulatory standards and medical writing best practices.
• Proficiency in writing, editing, and compiling complex scientific information.