Senior Medical Writer

About the role

The senior medical writer will partner cross-functionally with client teams in clinical development, operations, biostatistics, and regulatory affairs to lead the planning and preparation of high-quality clinical regulatory documents. This role involves producing protocols, publications, study reports, and investigator brochures to support drug development under brisk timelines.

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 to ensure timely completion of documents
• Ensure document development adheres to any relevant client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures
• Lead document message development in collaboration with client
• 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

Required skills

• Medical writing
• Project management
• Clinical regulatory documents
• Microsoft Word
• Document management systems

Nice to have

• Oncology
• Infectious Disease
• Vaccine experience
• Clinical study reports
• Lean authoring
• Structured content management
• ICH regulatory requirements

Qualifications

• Bachelor’s degree or higher in a relevant field

About the Company

TransPerfect is a family of companies providing global business solutions.