Senior Medical Writer - Regulatory Documents
Syneos Health, Inc., Morrisville, North Carolina, United States, 27560
Senior Medical Writer - Regulatory Documents
Updated: February 3, 2026
Location: Morrisville, NC, United States
Description 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 places the customer and the patient at the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and for, and we are driven to accelerate the delivery of therapies because we are passionate about changing lives.
Job Responsibilities
Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
Manage medical writing activities for individual studies, coordinating activities within and across departments with minimal supervision and resolving client comments.
Complete a variety of documents, including clinical study protocols, reports, patient narratives, investigator brochures, informed consents, DSURs, IND/ NDA submissions, and scientific meeting abstracts, posters, and presentations.
Adhere to regulatory standards such as ICH E3, company SOPs, client standards, and approved templates, ensuring projects are delivered on time and on budget.
Coordinate quality and editorial reviews, ensuring source documentation is managed and reviewing documents as needed.
Act as a peer reviewer for scientific content, clarity, consistency, and format across documents.
Review statistical analysis plans and table/figure specifications for content, grammar, format, and consistency, providing feedback on statistical output and document needs.
Build productive relationships with clients, department heads, biostatistics, regulatory affairs, and medical affairs to produce high‑quality deliverables.
Conduct online clinical literature searches and comply with copyright requirements.
Identify and propose solutions to resolve issues, provide technical support, training, and consultation, and contribute to internal process improvements.
Mentor and lead less experienced writers on complex projects.
Develop deep expertise in key regulatory topics affecting medical writing.
Manage project budget specifications, working within allocated hours and communicating status to leadership.
Complete required administrative tasks within specified timeframes and perform other related duties as assigned.
Travel: minimal (less than 25%) may be required.
Qualifications We are looking for a Senior Medical Writer with strong expertise in late‑phase protocol and Clinical Study Report writing. Experience authoring NDA, IND, IB, DSUR, RMP, briefing package, and response documents is highly regarded.
Benefits
Company car or car allowance
Health benefits: Medical, Dental and Vision
Company match 401(k)
Eligibility to participate in Employee Stock Purchase Plan
Commission/bonus potential based on company and individual performance
Flexible paid time off (PTO) and sick time
Salary Range $80,600.00 - $145,000.00
EEO Statement The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations to assist employees or applicants to perform essential job functions, and to ensure a diverse, equitable and inclusive workplace.
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Description 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 places the customer and the patient at the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and for, and we are driven to accelerate the delivery of therapies because we are passionate about changing lives.
Job Responsibilities
Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
Manage medical writing activities for individual studies, coordinating activities within and across departments with minimal supervision and resolving client comments.
Complete a variety of documents, including clinical study protocols, reports, patient narratives, investigator brochures, informed consents, DSURs, IND/ NDA submissions, and scientific meeting abstracts, posters, and presentations.
Adhere to regulatory standards such as ICH E3, company SOPs, client standards, and approved templates, ensuring projects are delivered on time and on budget.
Coordinate quality and editorial reviews, ensuring source documentation is managed and reviewing documents as needed.
Act as a peer reviewer for scientific content, clarity, consistency, and format across documents.
Review statistical analysis plans and table/figure specifications for content, grammar, format, and consistency, providing feedback on statistical output and document needs.
Build productive relationships with clients, department heads, biostatistics, regulatory affairs, and medical affairs to produce high‑quality deliverables.
Conduct online clinical literature searches and comply with copyright requirements.
Identify and propose solutions to resolve issues, provide technical support, training, and consultation, and contribute to internal process improvements.
Mentor and lead less experienced writers on complex projects.
Develop deep expertise in key regulatory topics affecting medical writing.
Manage project budget specifications, working within allocated hours and communicating status to leadership.
Complete required administrative tasks within specified timeframes and perform other related duties as assigned.
Travel: minimal (less than 25%) may be required.
Qualifications We are looking for a Senior Medical Writer with strong expertise in late‑phase protocol and Clinical Study Report writing. Experience authoring NDA, IND, IB, DSUR, RMP, briefing package, and response documents is highly regarded.
Benefits
Company car or car allowance
Health benefits: Medical, Dental and Vision
Company match 401(k)
Eligibility to participate in Employee Stock Purchase Plan
Commission/bonus potential based on company and individual performance
Flexible paid time off (PTO) and sick time
Salary Range $80,600.00 - $145,000.00
EEO Statement The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations to assist employees or applicants to perform essential job functions, and to ensure a diverse, equitable and inclusive workplace.
#J-18808-Ljbffr