Sr. Medical Writer (Regulatory)

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do, simplifying and streamlining work so that we can deliver therapies faster and change lives.

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision.
• Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain‑language summaries; Periodic Safety Update Reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides, delivering projects on time and on budget.
• Coordinates quality and editorial reviews, ensures source documentation is managed appropriately, leads team document reviews, and reviews documents as needed.
• Acts as peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper format.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to define statistical output and document needs.
• Interacts and builds good working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate.
• Provides technical support, training, and consultation to department and company staff, and may contribute to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex projects as necessary.
• Develops deep expertise in key industry topics and regulatory requirements that affect medical writing.
• Aware of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work‑related duties as assigned.
• Minimal travel may be required (less than 25%).

Benefits

• Company car or car allowance
• Health benefits including medical, dental and vision
• Company match 401(k)
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonuses based on company and individual performance
• Flexible paid time off (PTO) and sick time (availability varies by location)

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on candidate qualifications, skills, and proficiency for the role.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered, and qualifications of incumbents may differ from those listed. Nothing herein should be construed to create an employment contract. The Company complies with the Americans with Disabilities Act, providing reasonable accommodations when appropriate.