Lead Regulatory Submissions Writer

1001 Syneos Health, LLC; California; Hybrid; USD 70,000 - 145,000; Full time

Benefits offered by this job

Company car allowance

Health benefits (Medical, Dental, VIs)

401k match

Commission/bonus eligibility

PTO & sick time

Job summary

Syneos Health, Inc. is seeking a Sponsor Dedicated Senior Regulatory Submissions Writer to lead regulatory writing deliverables for clinical submissions, ensuring accuracy and compliance with ICH, EMA, and FDA guidelines.

The role requires 3-5 years in regulatory writing within biopharma, devices, or CROs, with strong English grammar and AMA style familiarity. Minimal travel may be required, and collaboration across departments will be essential.

Qualifications

• 3-5 years of relevant experience in regulatory writing.
• Experience in biopharmaceutical, device, or CRO industry is required.
• Strong understanding of EMA, FDA, ICH regulations and good publication practices.

Responsibilities

• Lead the clear and accurate completion of medical writing deliverables for regulatory submissions.
• Coordinate medical writing activities within and across departments with minimal supervision.
• Lead the resolution of client comments and ensure on-time, on-budget delivery.
• Mentor less experienced writers on complex projects.

Skills

Regulatory writing

Medical writing

Quality coordination

Job description

Syneos Health, Inc. is seeking a Sponsor Dedicated Senior Regulatory Submissions Writer to lead regulatory writing deliverables for clinical submissions, ensuring accuracy and compliance with ICH, EMA, and FDA guidelines.

The role requires 3-5 years in regulatory writing within biopharma, devices, or CROs, with strong English grammar and AMA style familiarity. Minimal travel may be required, and collaboration across departments will be essential.