Position Summary：
We are seeking a highly motivated detail-oriented Medical Writer to join our dynamic team. The successful candidate will be responsible fdeveloping high-quality, scientifically rigorous, compliant clinical documentation to support our clinical development programs. This role is critical in communicating complex clinical data to regulatory authorities, investigators, the scientific community.
Key Responsibilities
AuthManage Key Documents: Plan, write, edit, review critical clinical trial documents, including:
-Clinical Study Protocols (amendments)
-Investigators Brochures (IBs)
-Informed Consent Forms (ICFs)
-Clinical Study Reports (CSRs)
-Scientific publications (manuscripts, abstracts fconferences)
Collaborate with Cross-Functional Teams: Work closely with Biostatistics, Clinical Operations, Regulatory Affairs, Medical Science to gather information, interpret data, ensure accuracy consistency across all documentation.
Manage Timelines Strategy: Manage multiple writing assignments simultaneously, ensuring all deliverables are met within established timelines. Contribute to document strategy planning.
Review Provide Input: Provide medical writing input fother key documents such as regulatory submissions (e.g., IND, NDA, BLA, MAA), briefing books, patient narratives.
Qualifications Experience
Education:
Advanced degree Masters in a life sciences, medical, related scientific discipline is required.
Experience:
Minimum of 3-5 years of direct experience in clinical/regulatory medical writing within the pharmaceutical, biotechnology, CRO industry.
Proven track record of independently authoring key clinical documents (Protocols, CSRs, IBs) from start to finish.
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