Remote CNS Medical Writer for Clinical Development

Sigma Systems, Inc.; Marlborough (MA); Remote; USD 120,000 - 170,000; Full time

Job summary

Sigma Systems is seeking an experienced Medical Writer - Clinical Development for a 4-month remote contract to support CNS/regulatory writing across pharmaceutical and biotechnology programs.

The role requires 5+ years in regulatory medical writing, with recent CNS focus, and involves authoring CSRs, protocols, IBs, briefing books, and regulatory submissions. Remote US work with cross-timezone collaboration.

Qualifications

• Bachelor's degree or higher in a scientific/medical life sciences discipline; advanced degree preferred.
• Minimum 5+ years of hands-on regulatory medical writing experience in pharma/biotech/clinical research.
• Experience independently authoring clinical and regulatory documents.
• Strong experience developing protocols, CSRs, IBs, and regulatory submission documents.
• Recent CNS therapeutic area experience is required.

Responsibilities

• Author, edit, and review clinical and regulatory documents such as protocols, CSRs, IBs, regulatory briefing books, IND/NDA submissions.
• Translate complex clinical and statistical information into submission-ready documents.
• Collaborate with cross-functional teams across time zones (US and Japan).
• Coordinate document review cycles and incorporate reviewer feedback to ensure accuracy.
• Manage document timelines and negotiate deliverables with stakeholders.
• Ensure compliance with regulatory guidelines, ICH, and GCP.

Skills

Regulatory writing

Clinical development

Document authoring

Cross-functional collaboration

Education

Bachelor's degree or higher in life sciences

Job description

Sigma Systems is seeking an experienced Medical Writer - Clinical Development for a 4-month remote contract to support CNS/regulatory writing across pharmaceutical and biotechnology programs.

The role requires 5+ years in regulatory medical writing, with recent CNS focus, and involves authoring CSRs, protocols, IBs, briefing books, and regulatory submissions. Remote US work with cross-timezone collaboration.