Senior Medical Writer
RemoteNew Jersey, United States
New Jersey, United StatesRemoteFull TimeSenior LevelAssociates DegreeSmall
Full TimeSenior LevelAssociates DegreeSmall
Job Summary
Lead the execution of clinical regulatory documents, including protocols, study reports, and investigator brochures, while managing project timelines and coordinating cross-functional stakeholders. Interpret data to create shell documents, plan kickoff meetings, and facilitate review feedback resolution to ensure timely delivery under brisk deadlines. Ensure all content adheres to client processes, templates, and ICH regulatory requirements while maintaining consistency across programs. Conduct literature searches and perform peer QC reviews as needed. Fully remote with occasional on-site attendance for key meetings.
Required Qualifications
- 5+ years as a medical writer in the CRO/biotech/pharmaceutical field
- Bachelor's degree or higher in a relevant field
- Experience writing documents according to established processes and document templates
- Expertise with Microsoft Word and other Microsoft applications
- Experience developing documents using document management systems, collaborative authoring tools, and review tools
- 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
- Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements
Desired Qualifications
- Oncology, Infectious Disease, or Vaccine experience
- Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
- Flexibility to work across multiple therapeutic areas, if needed
- Familiarity with lean authoring approaches and structured content management
- Working knowledge of ex-US regulatory requirements
- Comfortable adapting to new tools and technologies, if needed
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