Remote Senior Medical Writer — Regulatory Submissions

Syneos Health India Private Limited; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Syneos Health is seeking a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for US remote-based work. You will lead medical writing deliverables, ensure regulatory standards, and collaborate across clinical teams to prepare protocols, amendments, SAS, CSRs, and eCTD submissions.

The role requires 3-5 years of medical writing experience, strong editorial skills, and experience with regulatory submissions. Occasional travel may be required, up to 25%.

Qualifications

• 3-5 years of relevant experience in medical writing.
• Experience with protocols and protocol amendments.

Responsibilities

• Lead the completion of regulatory submission documents for multiple studies.
• Coordinate medical writing activities across departments with minimal supervision.
• Review and respond to client comments and ensure accuracy and clarity of documents.
• Mentor less experienced medical writers on complex projects.

Skills

Medical writing

Regulatory knowledge

Protocol writing

Team mentoring

Budget awareness

Job description

Syneos Health is seeking a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for US remote-based work. You will lead medical writing deliverables, ensure regulatory standards, and collaborate across clinical teams to prepare protocols, amendments, SAS, CSRs, and eCTD submissions.

The role requires 3-5 years of medical writing experience, strong editorial skills, and experience with regulatory submissions. Occasional travel may be required, up to 25%.