Senior Medical Writer & Regulatory Lead

Syneos Health/ inVentiv Health Commercial LLC; Pennsylvania; Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Company car

Health benefits

401k match

Stock plan

Bonus eligibility

Flexible PTO

Sick time

Job summary

Syneos Health / inVentiv Health Commercial LLC is seeking a senior medical writer to lead the delivery of writing projects across studies, ensuring scientific accuracy and regulatory compliance. You will coordinate activities within and across departments, mentor junior writers, and review documents for quality and consistency.

The role involves developing deep expertise in industry topics and regulatory guidelines, managing client communications, and supporting process improvements.

Qualifications

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, coordinating activities across departments with minimal supervision.
• Manages documents such as journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Ensures regulatory compliance (ICH E3, SOPs, templates) and on-time, on-budget delivery.
• Coordinates quality and editorial reviews; mentors less experienced writers as needed.
• Acts as peer reviewer for internal quality checks of scientific content and formatting.
• Interacts with clients and cross-functional teams to produce high‑quality writing deliverables.
• Identifies issues, provides technical training, and helps refine internal processes.
• Develops deep topic expertise in medical writing and regulatory guidelines.
• Manages budget awareness and communicates status to leadership.
• Completes administrative tasks and may involve travel (<25%).

Job description

Syneos Health / inVentiv Health Commercial LLC is seeking a senior medical writer to lead the delivery of writing projects across studies, ensuring scientific accuracy and regulatory compliance. You will coordinate activities within and across departments, mentor junior writers, and review documents for quality and consistency.

The role involves developing deep expertise in industry topics and regulatory guidelines, managing client communications, and supporting process improvements.