Senior Medical Writer — Remote, Lead Regulatory Documents

Synterex, Inc.; Princeton (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Synterex, Inc. is a global consortium of medical writing, submission publishing, and clinical science professionals. We seek an organized, motivated senior medical writer to partner with client teams across Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

Location is fully remote, with on-site meetings when requested. The role leads document execution, timelines, cross-functional coordination, and adherence

Qualifications

• 5+ years experience as a medical writer in the CRO/biotech/pharma field.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.
• Familiarity with lean authoring approaches and structured content management.
• Familiarity with ICH and US regulatory requirements; ex-US knowledge is desired.
• Expertise with Microsoft Word and related MS applications.
• Experience developing documents using document management systems and collaboration tools.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents.
• Ensure document development adheres to client processes, templates, and instructional documents.
• Serve as an expert on client document management system and related tools, templates, and procedures.
• 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 to resolve outstanding review feedback.
• Ensure consistency among client programs in messaging, formatting, and presentation of documents.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives (templates, style guides, reference management).

Skills

Verbal and written communication

Project management

Independent and collaborative work

Client-facing collaboration

Attention to detail

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Job description

Synterex, Inc. is a global consortium of medical writing, submission publishing, and clinical science professionals. We seek an organized, motivated senior medical writer to partner with client teams across Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

Location is fully remote, with on-site meetings when requested. The role leads document execution, timelines, cross-functional coordination, and adherence