Senior Medical Writer

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

📋 Description

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

• Collaborate across various functions including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams.

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

• Manage document execution and project management responsibilities, including the creation, maintenance, and communication of 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 the development of document messaging in collaboration with clients.

• Analyze data and create shell documents to aid in authoring.

• Organize and lead kickoff meetings.

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

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

• Ensure uniformity across client programs in terms of document messaging, formatting, and presentation.

• Conduct literature searches as necessary.

• Perform peer quality control reviews as required.

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

⛳️ Requirements

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

• A Bachelor’s degree or higher in a relevant discipline.

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

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

• Flexibility to work across various therapeutic areas, if necessary.

• Proven experience in drafting documents according to established processes and document templates.

• Familiarity with lean authoring methodologies and structured content management.

• Knowledge of the requirements for the preparation of key clinical and regulatory documents, including ICH and US regulatory guidelines; working knowledge of ex-US regulatory requirements is a plus.

• Proficiency in Microsoft Word and other Microsoft applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review platforms.

• Comfortable adapting to new tools and technologies as required.

• Ability to work independently as well as collaboratively while managing competing priorities.

• A service-oriented and proactive approach to project management.

• Excellent conflict management and negotiation skills.

• Comfortable offering suggestions based on prior experience.

• Strong written and verbal communication skills in English.

• Must reside in Germany and be legally authorized 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 state, federal, or local law.