Senior Medical Writer | France

Location: Remote job <p>We’re seeking&nbsp;an organized, motivated, and collaborative individual for our medical writing team.&nbsp;</p><p>The&nbsp;senior&nbsp;medical writer will partner cross-functionally&nbsp;with client teams in&nbsp;Clinical Development, Clinical Operations,&nbsp;Biostatistics,&nbsp;Regulatory, and Program Management in&nbsp;leading the&nbsp;planning and preparation of high-quality clinical regulatory documents. The medical writer may produce&nbsp;protocols, publications, study reports, investigator brochures,&nbsp;narratives,&nbsp;and module documents, according to client&nbsp;and agency guidelines,&nbsp;to support drug development under&nbsp;brisk&nbsp;timelines.&nbsp;</p><p style="min-height: 1.7em;"></p><h4><strong><u>Responsibilities</u></strong>:</h4><ul><li><p>Lead the&nbsp;execution of documents, including&nbsp;project management tasks such as&nbsp;creating,&nbsp;maintaining, and communicating&nbsp;timelines&nbsp;</p></li><li><p>Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)&nbsp;to ensure&nbsp;timely&nbsp;completion of&nbsp;documents&nbsp;</p></li><li><p>Ensure&nbsp;document development&nbsp;adheres&nbsp;to&nbsp;any&nbsp;relevant&nbsp;client processes, templates, and instructional&nbsp;documents&nbsp;</p></li><li><p>Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document&nbsp;development&nbsp;&nbsp;</p></li><li><p>Lead document message development in collaboration with&nbsp;client&nbsp;&nbsp;</p></li><li><p>Interpret data and create shell documents to support&nbsp;authoring&nbsp;</p></li><li><p>Plan and lead kickoff&nbsp;meetings&nbsp;&nbsp;</p></li><li><p>Facilitate resolution of review feedback including planning&nbsp;and leading&nbsp;comment resolution meetings&nbsp;(curate review comments to ensure&nbsp;meetings are&nbsp;efficient)&nbsp;&nbsp;</p></li><li><p>Follow-up with individual team members as&nbsp;needed to resolve outstanding review&nbsp;feedback&nbsp;</p></li><li><p>Ensure consistency among client programs in terms of messaging, formatting, and presentation of&nbsp;documents&nbsp;&nbsp;</p></li><li><p>Conduct literature searches as&nbsp;needed&nbsp;</p></li><li><p>Perform peer QC review as&nbsp;needed&nbsp;&nbsp;</p></li></ul><ul><li><p>Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed&nbsp;</p></li></ul><p style="min-height: 1.7em;"></p> <br> <ul><li><p>Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field&nbsp;&nbsp;</p></li><li><p>Bachelor’s degree&nbsp;or higher&nbsp;in a relevant field&nbsp;&nbsp;</p></li><li><p>Oncology, Infectious&nbsp;Disease, or Vaccine&nbsp;experience&nbsp;desired&nbsp;</p></li><li><p>Experience&nbsp;desired&nbsp;in writing&nbsp;clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5&nbsp;documents&nbsp;</p></li><li><p>Flexibility to&nbsp;work across multiple therapeutic areas, if needed&nbsp;</p></li><li><p>Experience&nbsp;writing documents according to&nbsp;established processes and document&nbsp;templates&nbsp;</p></li><li><p>Familiarity with lean authoring approaches&nbsp;and structured content management&nbsp;</p></li><li><p>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&nbsp;desired&nbsp;&nbsp;</p></li><li><p>Expertise&nbsp;with Microsoft Word and other Microsoft applications&nbsp;&nbsp;</p></li><li><p>Experience&nbsp;developing documents&nbsp;using&nbsp;document management systems, collaborative authoring&nbsp;tools, and review&nbsp;tools&nbsp;</p></li><li><p>Comfortable&nbsp;adapting&nbsp;to new&nbsp;tools and&nbsp;technologies, if needed&nbsp;</p></li><li><p>Ability to work both independently and collaboratively in the face of competing&nbsp;priorities&nbsp;&nbsp;</p></li><li><p>Service-oriented and proactive approach to project&nbsp;management&nbsp;&nbsp;</p></li><li><p>Excellent conflict management and negotiation skills&nbsp;&nbsp;</p></li><li><p>Comfortable providing suggestions based on&nbsp;previous&nbsp;experience&nbsp;</p></li><li><p>Strong written and verbal communication skills&nbsp;in English</p></li></ul><p style="min-height: 1.7em;"></p><p style="min-height: 1.7em;"></p><p style="text-align:start;"><em>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</em></p><p style="text-align:start;"><em>&nbsp;</em></p><p style="text-align:start;"><em>For more information on the TransPerfect Family of Companies, please visit our website at </em><a rel="noopener" target="_blank" href="[Link Protected] applying, I confirm I have read and accept TransPerfect's Privacy Policy: </em><a rel="noopener" target="_blank" href="[Link Protected] more <a href="[Link Protected] Speaking Jobs in France</a> on Arbeitnow</a> GDPR Compliance: Sourced via verified public channels under Legitimate Interests (Art. 6(1)(f) GDPR). 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