Senior Medical Writer: Regulatory & Cross-Functional Lead

TransPerfect Translations International; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Job summary

TransPerfect Translations International is seeking a senior medical writer to join our clinical writing team in Warsaw. You will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare regulatory documents such as protocols, study reports, and investigator brochures under tight timelines.

You will lead document development, coordinate cross-functional contributors, and ensure adherence to client templates and ICH/regulatory

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharma.
• 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.
• Ability to work across multiple therapeutic areas, if needed.
• Experience writing documents according to established processes and document templates.
• Familiarity with lean authoring approaches and structured content management.
• Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired.
• Excellent written and verbal communication skills in English

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 (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 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 (curate review comments to ensure meetings are efficient)
• 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

Regulatory writing

Cross-functional collaboration

Project management

English proficiency

Literature review

Document management systems

Lean authoring

MS Word

Team coordination

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Job description

TransPerfect Translations International is seeking a senior medical writer to join our clinical writing team in Warsaw. You will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare regulatory documents such as protocols, study reports, and investigator brochures under tight timelines.

You will lead document development, coordinate cross-functional contributors, and ensure adherence to client templates and ICH/regulatory