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.ResponsibilitiesLead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelinesCoordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documentsEnsure document development adheres to any relevant client processes, templates, and instructional documentsServe as an expert on client document management system and related tools, templates, and procedures to ensure efficient document developmentLead document message development in collaboration with clientInterpret data and create shell documents to support authoringPlan and lead kickoff meetingsFacilitate 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 feedbackEnsure consistency among client programs in terms of messaging, formatting, and presentation of documentsConduct literature searches as neededPerform peer QC review as neededContribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if neededExperience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical fieldBachelor’s degree or higher in a relevant fieldOncology, Infectious Disease, or Vaccine experience desiredExperience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documentsFlexibility to work across multiple therapeutic areas, if neededExperience writing documents according to established processes and document templatesFamiliarity with lean authoring approaches and structured content managementFamiliarity 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 desiredExpertise with Microsoft Word and other Microsoft applicationsExperience developing documents using document management systems, collaborative authoring tools, and review toolsComfortable adapting to new tools and technologies, if neededAbility to work both independently and collaboratively in the face of competing prioritiesService-oriented and proactive approach to project managementExcellent conflict management and negotiation skillsComfortable providing suggestions based on previous experienceStrong written and verbal communication skills
15 days ago