Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job summary

A leading biopharmaceutical organization is seeking a Senior Principal Medical Writer to develop regulatory documents, manage medical writing projects, and mentor junior staff. This remote role requires a relevant degree and experience in regulatory writing and project management. Join a passionate team dedicated to accelerating the delivery of therapies and making a significant impact in healthcare.

Benefits

Health benefits

401k company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• Experience in developing regulatory documents for global submission.
• Proven ability to manage medical writing projects.
• Knowledge of ICH guidelines and regulatory standards.

Responsibilities

• Develop regulatory documents for submission to global agencies.
• Manage timelines and communication for medical writing projects.
• Participate in cross-functional meetings to discuss project progress.
• Mentor junior medical writing staff.

Skills

Regulatory writing

Project management

Cross-functional collaboration

Education

Relevant degree (e.g., life sciences)

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Updated: October 2, 2025
Location: USA-HI-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. 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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

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. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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.

Syneos Health offers a range of benefits, including 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

Get to know Syneos Health

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.