We are looking for a dedicated and collaborative individual to join our medical writing team as a Senior Medical Writer. In this role, you will work cross-functionally with teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to lead the planning and preparation of high-quality clinical regulatory documents. You will be responsible for producing protocols, publications, study reports, investigator brochures, narratives, and module documents, adhering to client and agency guidelines while working under tight deadlines.

• 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.
• Serve as an expert on the client document management system and related tools, templates, and procedures to ensure efficient document development.
• Lead document message development in collaboration with clients.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate resolution of review feedback, including planning and leading comment resolution meetings to ensure efficiency.
• Follow up with individual team members as needed to resolve outstanding review feedback.
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management) as necessary.