Senior Medical Writer | Germany

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 TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law   For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com. By applying, I confirm I have read and accept TransPerfect's Privacy Policy: https://www.transperfect.com/about/data-privacy-recruiting Find Jobs in Germany on Arbeitnow