Remote Senior Medical Writer: Lead Regulatory Documents

OpenKrill; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

TransPerfect seeks a senior medical writer to partner with Clinical Development, Regulatory, Biostatistics, and Program Management in planning and preparing high-quality regulatory documents for drug development. The role may include protocols, publications, study reports, investigator brochures, narratives, and module documents, with on-time delivery.

The ideal candidate has 5+ years of medical writing experience in CRO/biotech/pharma, a Bachelor's degree or higher, and familiarity with ICH and

Qualifications

• 5+ years of experience as a medical writer in CRO/biotech/pharmaceutical fields.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and module 5 documents.
• Familiarity with ICH and US regulatory requirements; knowledge of ex-US requirements is a plus.

Responsibilities

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion.
• Adhere to client processes, templates, and instructional documents.
• Serve as an expert on client document management systems and related tools.
• 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 and plan comment resolution meetings.
• Ensure consistency across client programs in messaging, formatting, and presentation.

Skills

Project management

Cross-functional collaboration

Excellent written communication

Editorial QA

Literature searching

Education

Bachelor's degree or higher

Tools

Microsoft Word

Document management systems

Review tools

Job description

TransPerfect seeks a senior medical writer to partner with Clinical Development, Regulatory, Biostatistics, and Program Management in planning and preparing high-quality regulatory documents for drug development. The role may include protocols, publications, study reports, investigator brochures, narratives, and module documents, with on-time delivery.

The ideal candidate has 5+ years of medical writing experience in CRO/biotech/pharma, a Bachelor's degree or higher, and familiarity with ICH and