Senior Medical Writer

Synterex

Senior Medical Writer responsible for leading preparation of clinical regulatory documents for Synterex. Collaborating cross-functionally to meet drug development timelines with adherence to guidelines and quality standards.

Posted 6/17/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
Coordinate cross-functional client contributors and stakeholders as well as internal resources to ensure timely completion of documents
Ensure document development adheres to any relevant client processes, templates, and instructional documents
Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
Lead document message development in collaboration with 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
Follow-up with individual team members as needed to resolve outstanding review feedback
Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
Conduct literature searches as needed
Perform peer QC review as needed
Contribute to medical writing operational initiatives, if needed

Requirements

What you’ll need

5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field
Bachelor’s degree or higher in a relevant field
Oncology, Infectious Disease, or Vaccine experience desired
Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
Flexibility to work across multiple therapeutic areas
Familiarity with lean authoring approaches and structured content management
Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
Expertise with Microsoft Word and other Microsoft applications
Experience developing documents using document management systems, collaborative authoring tools, and review tools
Comfortable adapting to new tools and technologies
Excellent conflict management and negotiation skills
Strong written and verbal communication skills

Benefits

Comp & perks

Remote or on-site services
Equal employment opportunities
Prohibits discrimination and harassment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingclinical study reportsprotocolsprotocol amendmentsinvestigator brochuresmodule 2 documentsmodule 5 documentslean authoring approachesstructured content managementdata interpretation

Soft Skills

conflict managementnegotiation skillswritten communicationverbal communicationteam coordinationstakeholder managementtimelinessflexibilitypeer reviewfacilitation