Remote Senior Medical Writer — Regulatory Submissions Lead

Syneos Health, Inc.; Oregon; Hybrid; USD 81,000 - 145,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO and sick time

Job summary

Syneos Health, Inc. is a global life sciences organization offering sponsor-dedicated senior medical writing support for regulatory submission documents. The role can be remote from the US or Canada, with responsibilities spanning protocols, amendments, clinical study reports, and NDA/eCTD submissions.

Strong regulatory knowledge and writing expertise are essential. The position emphasizes collaboration across Clinical Solutions teams, budget awareness, mentorship of junior writers, and

Qualifications

• 3-5 years of medical writing experience.
• Experience in Protocol writing for biopharmaceuticals, devices, or CRO.
• Strong understanding of FDA and ICH regulations and good publication practices.
• Experience with late development and Oncology/Hematology/Cell therapy.
• Experience writing in AMA Manual of Style.

Responsibilities

• Lead the preparation of medical writing deliverables for protocols, amendments, clinical study reports, and NDA/eCTD submissions.
• Coordinate activities across departments with minimal supervision.
• Respond to client comments and manage editorial reviews.
• Ensure regulatory standards and templates are followed.
• Mentor less experienced writers and develop topic expertise.
• Stay within budgeted hours and assist with process improvements.
• Limited travel may be required (less than 25%).

Skills

Medical writing

Protocol writing

Regulatory documents

FDA/ICH knowledge

Veeva/CARA

Tools

Veeva/CARA

Job description

Syneos Health, Inc. is a global life sciences organization offering sponsor-dedicated senior medical writing support for regulatory submission documents. The role can be remote from the US or Canada, with responsibilities spanning protocols, amendments, clinical study reports, and NDA/eCTD submissions.

Strong regulatory knowledge and writing expertise are essential. The position emphasizes collaboration across Clinical Solutions teams, budget awareness, mentorship of junior writers, and