Medical Writer II (Narrative Writing)

We are seeking a Medical Writer II with a strong background in CSR (Clinical Study Report) safety narratives writing. This role is responsible for compiling, writing, and editing a variety of medical writing deliverables to present scientific information clearly and accurately. The ideal candidate will work both independently and collaboratively, ensuring all documents adhere to established regulatory standards and best practices.

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.