Senior Medical Writer

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee the planning and preparation of high-quality clinical regulatory documents.

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Manage document execution and project oversight, which includes establishing, updating, and communicating timelines.

• Coordinate contributions from cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing.

• Ensure that document development adheres to client processes, templates, and instructional guidelines.

• Act as a subject matter expert on client document management systems, tools, templates, and procedures.

• Guide document message development in collaboration with clients.

• Analyze data and create shell documents to facilitate authoring.

• Organize and lead kickoff meetings.

• Manage the resolution of review feedback and conduct comment resolution meetings.

• Follow up with team members to address any outstanding review feedback.

• Maintain consistency in messaging, formatting, and presentation across client programs.

• Conduct literature searches as necessary.

• Perform peer quality-control reviews when required.

• Contribute to operational initiatives in medical writing, such as templates, style guides, and reference management.

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sector.

• Bachelor’s degree or higher in a relevant field.

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred.

• Proven experience in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents is desired.

• Willingness to work across various therapeutic areas.

• Proficiency in writing documents according to established processes and templates.

• Familiarity with lean authoring techniques and structured content management.

• Knowledge of ICH and US regulatory requirements; familiarity with ex-US regulatory requirements is a plus.

• Expertise in Microsoft Word and other Microsoft applications.

• Experience with document management systems, collaborative authoring tools, and review tools.

• Adaptability to new tools and technologies.

• Capability to work independently and collaboratively while managing competing priorities.

• Service-oriented and proactive approach to project management.

• Exceptional conflict management and negotiation skills.

• Comfortable making suggestions based on prior experience.

• Strong written and verbal communication skills in English.

• Must reside in Germany and possess legal authorization to work there.

🏝️ Benefits

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.