Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer for regulatory submissions in oncology. The ideal candidate will manage writing projects and mentor junior staff, ensuring compliance with ICH guidelines. This role offers a salary range of $114,000 - $210,900 and various benefits, including health insurance and flexible paid time off.

Benefits

Company car or car allowance

Health benefits including Medical, Dental, and Vision

401k company match

Employee Stock Purchase Plan

Flexible paid time off (PTO) and sick time

Qualifications

• Experience in regulatory writing with a strong understanding of ICH guidelines.
• Proven project management skills.
• Excellent communication skills to liaise with cross-functional teams.

Responsibilities

• Develop regulatory documents for submission globally.
• Manage medical writing projects and timelines.
• Mentor junior medical writing staff.

Skills

Regulatory document development

Project management

Cross-functional collaboration

Mentoring junior staff

Education

Degree in life sciences or related field

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Updated: October 2, 2025
Location: USA-AL-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, in accordance with ICH and other global guidelines, standards and processes.
• 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), 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.

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 to include Medical, Dental and Vision, 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.