Senior Medical Writer

We’re seeking an organized, motivated, and collaborative individual for our medical writing team. 

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines. 

Location: Fully remote in the US, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.  

Responsibilities:

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines 

• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents 

• Ensure document development adheres to any relevant client processes, templates, and instructional documents 

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