Senior Medical Writer - Regulatory Docs (Remote)

Transperfect Gaming Solutions; Princeton (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

TransPerfect is seeking an organized, motivated medical writer to join our remote US team. The senior writer will partner with Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to prepare high-quality regulatory documents under tight timelines.

This fully remote role requires on-site meetings with clients as requested, and responsibilities include leading document timelines, cross-functional coordination, template adherence, and expert use of document management

Qualifications

• Requires 5+ years as a medical writer in CRO/biotech/pharmaceuticals.
• Bachelor's degree or higher in a relevant field is required.
• Familiarity with ICH and US regulatory requirements is desired.

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 to ensure efficient document development
• 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
• 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), if needed

Skills

Medical writing

Project management

Cross-functional collaboration

Regulatory documents

Templates & style guides

Education

Bachelor's degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Job description

TransPerfect is seeking an organized, motivated medical writer to join our remote US team. The senior writer will partner with Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to prepare high-quality regulatory documents under tight timelines.

This fully remote role requires on-site meetings with clients as requested, and responsibilities include leading document timelines, cross-functional coordination, template adherence, and expert use of document management