Senior Medical Writer | US
About The Position
TransPerfect is seeking an organized, motivated, and collaborative Senior Medical Writer to join its medical writing team. The writer partners with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality clinical regulatory documents. Documents may include protocols, publications, study reports, investigator brochures, narratives, and module documents prepared according to client and agency guidelines to support drug development under brisk timelines. The position is fully remote in the United States, with attendance at key client meetings on site, such as roundtable or kickoff meetings, when requested. The role is full-time and permanent.
Requirements
- At least 5 years of experience as a medical writer in the CRO, biotech, or pharmaceutical field.
- Bachelor’s degree or higher in a relevant field.
- Experience writing documents according to established processes and document templates.
- Familiarity with lean authoring approaches and structured content management.
- Familiarity with requirements for preparing key clinical and regulatory documents, including ICH and US regulatory requirements.
- Expertise with Microsoft Word and other Microsoft applications.
- Experience developing documents using document management systems, collaborative authoring tools, and review tools.
- Ability to adapt to new tools and technologies as needed.
- Ability to work independently and collaboratively while managing competing priorities.
- Service-oriented and proactive approach to project management.
- Excellent conflict management and negotiation skills.
- Comfort providing suggestions based on previous experience.
- Strong written and verbal communication skills.
Nice To Haves
- 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 as needed.
- Working knowledge of ex-US regulatory requirements.
Responsibilities
- Lead document execution, including project management tasks such as creating, maintaining, and communicating timelines.
- Coordinate cross-functional client contributors and stakeholders, and internal resources such as quality control and publishing, to ensure timely document completion.
- Ensure document development follows relevant client processes, templates, and instructional documents.
- Serve as an expert on the client document management system and related tools, templates, and procedures.
- Lead document message development in collaboration with the client.
- Interpret data and create shell documents to support authoring.
- Plan and lead kickoff meetings.
- Facilitate resolution of review feedback, including planning and leading comment resolution meetings and curating comments to keep meetings efficient.
- Follow up with individual team members as needed to resolve outstanding review feedback.
- Ensure consistency among client programs in document messaging, formatting, and presentation.
- Conduct literature searches as needed.
- Perform peer quality-control reviews as needed.
- Contribute to medical writing operational initiatives, such as templates, style guides, and reference management, if needed.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
