Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer to develop regulatory documents and manage writing projects. This role involves collaboration across teams and mentoring junior staff. The ideal candidate has extensive experience in regulatory document preparation and project management. The position offers a competitive salary range of $114,000 - $210,900 and emphasizes a culture of growth and support.

Qualifications

• Experience in developing regulatory documents for submission.
• Ability to manage medical writing projects and timelines.
• Experience in mentoring junior medical writing staff.

Responsibilities

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

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Updated: October 2, 2025
Location: USA-OH-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.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

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.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

We believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

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 and will not be discriminated against.