Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health, Inc.; United States; Remote; USD 114,000 - 211,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer for regulatory oncology projects. This role involves developing regulatory documents for global submissions, managing medical writing projects, and mentoring junior writers. The ideal candidate has strong project management skills and experience in regulatory writing. Join a dynamic team where your contributions matter globally.

Qualifications

• Experience in regulatory writing and document development.
• Strong project management skills to develop timelines and handle medical writing projects.
• Ability to mentor and guide junior medical writing staff.

Responsibilities

• Develop regulatory documents for submission to agencies globally.
• Manage medical writing projects, including timelines and team communication.
• Participate in cross-functional meetings for input on deliverables.

Skills

Regulatory document development

Project management

Cross-functional communication

Mentorship

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Updated: October 2, 2025
Location: USA-OR-Remote

Description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor. 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 that we do.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Job Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally.
• Manage medical writing projects, including developing timelines and communication with cross-functional team members.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s).
• Participate in cross-functional process improvement initiatives.
• Manage internal and contract medical writing resources as required.
• Mentor more junior medical writing staff.

Salary Range: $114,000.00 - $210,900.00

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.