Senior Medical Writer

About the role

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to lead the planning and preparation of high-quality clinical regulatory documents. This role involves producing protocols, publications, study reports, investigator brochures, narratives, and module documents according to client and agency guidelines 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
• ICH Guidelines
• US Regulatory Requirements

Nice to have

• Oncology
• Infectious Disease
• Vaccine
• Clinical Study Reports
• Lean Authoring
• Structured Content Management

Qualifications

• Bachelor’s degree or higher in a relevant field
• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field

About the Company

TransPerfect is a family of companies providing global business solutions.