Senior Medical Writer: Cross-Functional Regulatory Lead

TransPerfect; Polska; On-site; PLN 180,000 - 280,000; Full time

Job summary

TransPerfect is seeking a senior medical writer to lead the planning and preparation of high-quality regulatory documents for clinical development. The role requires collaboration with Clinical Development, Operations, Biostatistics, Regulatory, and Program Management teams to meet brisk timelines.

Responsibilities include leading document execution, coordinating contributors, and ensuring templates and processes are followed.

Qualifications

• 5+ years as a medical writer in CRO/biotech/pharma.
• Bachelor’s degree or higher in a relevant field.
• Experience with ICH and regulatory document formats.
• Strong English written and verbal communication.

Responsibilities

• Lead the planning and preparation of regulatory documents.
• Coordinate cross-functional client contributors and internal resources.
• Ensure adherence to client processes, templates, and guidelines.
• Perform peer QC review and literature searches.
• Develop shell documents and lead kickoff meetings.
• Manage timelines and project communications.

Skills

Medical writing

Cross-functional collaboration

English proficiency

Project management

Education

Bachelor's degree or higher

Tools

MS Word

Job description

We’re seeking an organized, motivated, and collaborative individual for our medical writing team.

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce 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 (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
• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility 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
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools and technologies, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based on previous experience
• Strong written and verbal communication skills in English
  
  
  

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