Medical Writer II (QC of Regulatory Docs)

We are seeking a Medical Writer II with a strong background in QC (Quality Control) of regulatory documents. This role involves compiling, writing, and editing a variety of medical writing deliverables to ensure scientific information is presented clearly and accurately. The ideal candidate will have hands-on experience in the biopharmaceutical industry, a keen eye for detail, and a deep understanding of regulatory standards and guidelines.

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.