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2 weeks ago
We are seeking a Medical Writer II with significant experience in writing CSR safety narratives. This role involves compiling, writing, editing, and coordinating medical writing deliverables to ensure that scientific information is presented clearly and accurately.
Key Responsibilities:
- Core Writing & Documentation: Compile, write, edit, and coordinate a variety of medical writing deliverables, focusing primarily 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.
Requirements & Qualifications:
- 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.
Benefits & Opportunities:
- Mentorship & Professional Development: Mentor less-experienced medical writers on projects and maintain a strong working knowledge of the drug development process, regulatory guidelines, and industry best practices.
- Collaboration & Project Management: Lead document reviews, resolve comments from clients, and ensure source documentation is managed appropriately.
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