Medical Writer II (CSR Safety Narratives)

We are seeking a Medical Writer II with significant experience in CSR (Clinical Study Report) safety narratives writing. This role involves the compilation, writing, editing, and coordination of medical writing deliverables, ensuring that scientific information is presented with clarity and accuracy. The ideal candidate will work both independently and collaboratively, demonstrating a strong understanding of regulatory guidelines and the drug development process.

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.