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
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
This overview was written from the original listing to help you understand the role. Always confirm the specifics on the employer’s application page.
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Senior Medical Writer | Germany arbeitnow TransPerfect Remote job · 10/14/2026 Arbeitgeber: Primetime
SoSafe ist ein hervorragender Arbeitgeber, der dir die Möglichkeit bietet, in einem dynamischen und hochmotivierten Team zu arbeiten, das Vielfalt und Innovation schätzt. Mit flexiblen Arbeitszeiten, 33 Tagen Urlaub und einem individuellen Weiterbildungsbudget unterstützt SoSafe nicht nur deine berufliche Entwicklung, sondern sorgt auch für eine ausgewogene Work-Life-Balance. In Köln hast du die Chance, Teil eines schnell wachsenden Scale-ups zu werden, das sich aktiv für die Sicherheit in der digitalen Welt einsetzt und dir zahlreiche Möglichkeiten zur persönlichen und fachlichen Entfaltung bietet.
