Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job summary

A leading biopharmaceutical solutions organization is looking for a Senior Principal Medical Writer specializing in regulatory documents for oncology. The role involves managing projects, collaborating with teams, and mentoring junior staff. The position offers a competitive salary range between $114,000 and $210,900, along with comprehensive benefits including flexible PTO. This is a remote position based in South Dakota.

Benefits

Company car or allowance

Health benefits

401k company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• Proven experience in regulatory writing, preferably in the oncology field.
• Strong communication skills, both verbal and written.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Develop regulatory documents for submissions.
• Manage timelines and communicate with cross-functional teams.
• Review project documents and deliverables.

Skills

Regulatory documentation

Project management

Cross-functional collaboration

Mentorship

Education

Advanced degree in life sciences or related field

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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.

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 to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

What We Offer

We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO) and sick time.

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 and will not be discriminated against.