Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health, Inc.; Iowa (LA); Remote; USD 114,000 - 211,000; Full time

Job summary

A biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer for regulatory documents, particularly in oncology. The role involves managing projects, mentoring junior staff, and working collaboratively across teams to ensure quality submissions. Competitive salary and various benefits including a car allowance and flexible paid time off are offered.

Benefits

Health benefits including Medical, Dental, and Vision

Company match 401k

Eligibility for bonuses based on performance

Flexible paid time off

Qualifications

• Experience in medical writing, ideally within oncology.
• Ability to manage timelines and communications effectively.
• Experience with regulatory submission processes.

Responsibilities

• Develop regulatory documents for submission globally.
• Manage medical writing projects and timelines.
• Participate in defining best practices for document preparation.

Skills

Medical writing

Regulatory document development

Project management

Cross-functional team communication

Mentoring

Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Updated: October 2, 2025
Location: USA-IA-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.
• 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 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, Eligibility to earn commissions/bonus based on company and individual performance, 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.