Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job summary

A biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer focused on regulatory documents in oncology. The role involves managing writing projects, contributing to cross-functional teams, and mentoring junior staff. Competitive salary range from $114,000 to $210,900, with a commitment to employee development and a supportive culture.

Benefits

Valuable benefits

Career development opportunities

Quality-of-life balance

Qualifications

• Experience with regulatory submissions in biopharmaceuticals.
• Strong communication skills for cross-functional teams.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Develop regulatory documents for submission to global agencies.
• Manage medical writing projects and timelines.
• Review and provide input on medical writing deliverables.

Skills

Regulatory document development

Project management

Cross-functional collaboration

Mentoring

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job 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, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• 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), as appropriate.
• 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.

What We Offer

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

Equal Opportunity Employer

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.