Medical Writer

Position Summary:

We are seeking a highly motivated and detail-oriented Medical Writer to join our dynamic team. The successful candidate will be responsible for developing high-quality, scientifically rigorous, and compliant clinical documentation to support our clinical development programs. This role is critical in communicating complex clinical data to regulatory authorities, investigators, and the scientific community.

Key Responsibilities

Author and Manage Key Documents: Plan, write, edit, and review critical clinical trial documents, including:

-Clinical Study Protocols (and amendments)

-Investigator's Brochures (IBs) -Informed Consent Forms (ICFs)

-Clinical Study Reports (CSRs)

-Scientific publications (manuscripts, abstracts for conferences)

Collaborate with Cross-Functional Teams: Work closely with Biostatistics, Clinical Operations, Regulatory Affairs, and Medical Science to gather information, interpret data, and ensure accuracy and consistency across all documentation.

Manage Timelines and Strategy: Manage multiple writing assignments simultaneously, ensuring all deliverables are met within established timelines.

Contribute to document strategy and planning.

Review and Provide Input: Provide medical writing input for other key documents such as regulatory submissions (e.g., IND, NDA, BLA, MAA), briefing books, and patient narratives. Qualifications and Experience Education:

Advanced degree Master's in a life sciences, medical, or related scientific discipline is required.

Experience: Minimum of 3-5 years of direct experience in clinical/regulatory medical writing within the pharmaceutical, biotechnology, or CRO industry.

Proven track record of independently authoring key clinical documents (Protocols, CSRs, IBs) from start to finish.