Senior Medical Writer | Germany arbeitnow TransPerfect Remote job · 10/14/2026

Responsibilities :

• Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control (QC), publishing)to ensuretimelycompletion ofdocuments
• Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient documentdevelopment
• Lead document message development in collaboration withclient
• Interpret data and create shell documents to supportauthoring
• Plan and lead kickoffmeetings
• Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient)
• Follow-up with individual team members asneeded to resolve outstanding reviewfeedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments
• Conduct literature searches asneeded
• 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 degreeor higherin a relevant field
• Oncology, InfectiousDisease, or Vaccineexperiencedesired
• Experiencedesiredin writingclinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents
• Flexibility towork across multiple therapeutic areas, if needed
• Experiencewriting documents according toestablished processes and documenttemplates
• Familiarity with lean authoring approachesand 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 isdesired
• Expertisewith Microsoft Word and other Microsoft applications
• Experiencedeveloping documentsusingdocument management systems, collaborative authoringtools, and reviewtools
• Comfortableadaptingto newtools andtechnologies, if needed
• Ability to work both independently and collaboratively in the face of competingpriorities
• Service-oriented and proactive approach to projectmanagement
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based onpreviousexperience
• Strong written and verbal communication skillsin English

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