Reporting to the Senior Director of Medical Writing, the Medical Writer is responsible for developing high-quality, scientifically accurate clinical and regulatory documents according to international regulatory requirements and internal document standards. This role involves interactions on a regular basis with members of internal departments.
- Writing and integration of appropriate clinical data into protocols, investigator brochures, clinical study reports, and other clinical and regulatory documents, with input from functional area experts.
- Coordinating the overall development and finalization process for assigned documents, including developing and driving timelines, hosting document review and comment resolution meetings, and obtaining approvals.
- Building and maintaining relationships with study team members, which include representatives from internal departments such as Clinical Development, Clinical Operations, Regulatory Affairs, and Biostatistics.
- Representing medical writing on project teams and actively participating in interactions and providing feedback on data description, presentation, and analysis.
- Review documents for clarity, accuracy, and consistency between documents.
- Developing and maintaining in-depth therapeutic and product knowledge.
- Providing quality control review of various clinical and regulatory documents.
- Advance the medical writing group via the development of writing processes and working standards.
- BS/BA required; Master’s/PhD/PharmD in life sciences preferred.
- Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and/or clinical data.
- Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines.
- Strong attention to detail and drive to produce high-quality documents.