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.

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Medical Writer II (QC of Regulatory Docs)