Senior Medical Writer

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

📋 Description

• Oversee the planning and preparation of top-quality clinical regulatory documentation.

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

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents in accordance with client and agency standards.

• Direct document execution, which includes establishing, maintaining, 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 materials.

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

• Guide document messaging development in collaboration with clients.

• Analyze data and create shell documents to assist in the authoring process.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and lead comment resolution discussions.

• Follow up with team members to address outstanding review comments.

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

• Conduct literature searches as required.

• Carry out peer quality control reviews as necessary.

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

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer within the CRO/biotech/pharmaceutical industries.

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

• Experience in Oncology, Infectious Disease, or Vaccines is preferred.

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

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

• Experience in creating documents in accordance with established processes and templates.

• Familiarity with lean authoring methods and structured content management.

• Knowledge of requirements for key clinical and regulatory documents, including ICH and US regulatory standards; experience with ex-US regulatory requirements is advantageous.

• Proficient in Microsoft Word and other Microsoft applications.

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

• Willingness to adapt to new tools and technologies as needed.

• Ability to work both independently and collaboratively while managing competing priorities.

• Possess a service-oriented and proactive attitude towards project management.

• Excellent conflict management and negotiation skills.

• Comfortable offering suggestions based on prior experience.

• Strong written and verbal communication skills in English.

• Reside in Germany and have 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 state, federal, or local law.