Lead Medical Writer & Regulatory Strategy Lead

Syneos Health, Inc.; Tennessee; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Company car/Car allowance

Health benefits

401k matching

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO & sick time

Job summary

Syneos Health/ inVentiv Health Commercial LLC is seeking a senior medical writer to lead the clear and accurate completion of medical writing deliverables, coordinating activities across departments with minimal supervision. The role involves mentoring junior staff, ensuring regulatory compliance (ICH E3 and SOPs), and guiding quality reviews. You will interact with clients to produce timely, compliant writing outputs and maintain project budgets.

Qualifications

• Produces clear, accurate medical writing deliverables across studies.
• Leads coordination of medical writing activities with minimal supervision.
• Ensures adherence to regulatory standards and SOPs (ICH E3) and approved templates.

Responsibilities

• Leads completion of manuscripts, abstracts, posters, and presentations.
• Coordinates quality and editorial reviews; manages source documentation.
• Acts as peer reviewer to ensure scientific accuracy and proper formatting.
• Interacts with clients and internal teams to deliver writing outputs.
• Provides training, consultation, and process improvements to staff.
• Mentors less experienced writers on complex projects.

Skills

Medical writing

Project coordination

Regulatory knowledge

Mentoring

Client communication

Budgeting & scheduling

Job description

Syneos Health/ inVentiv Health Commercial LLC is seeking a senior medical writer to lead the clear and accurate completion of medical writing deliverables, coordinating activities across departments with minimal supervision. The role involves mentoring junior staff, ensuring regulatory compliance (ICH E3 and SOPs), and guiding quality reviews. You will interact with clients to produce timely, compliant writing outputs and maintain project budgets.