Senior Principle Medical Writer

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

Job summary

A leading biopharmaceutical solutions organization is seeking an Associate Director, Principal Medical Writer I to develop regulatory documents for global submissions. This role involves managing medical writing projects, providing strategic direction, and mentoring junior writers. Candidates should have an advanced degree in life sciences and experience in regulatory documentation. Competitive salary package offered, along with comprehensive benefits including health insurance and 401(k) matching.

Benefits

Car allowance

Health benefits (Medical, Dental, Vision)

401(k) with company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• Experience in preparing regulatory documents for global submission.
• Strong understanding of ICH guidelines and clinical trial processes.
• Excellent communication and leadership skills.

Responsibilities

• Develop regulatory documents for submissions to regulatory agencies globally.
• Manage medical writing projects and timelines effectively.
• Provide input in cross-functional meetings for project deliverables.

Skills

Regulatory document development

Project management

Cross-functional collaboration

Mentoring

Education

Advanced degree in Life Sciences

Job description

Overview

Updated: September 16, 2025
Location: USA-OK-Remote

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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we 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 (working with the study/project teams, as necessary) 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) (eg, Protocols and Statistical Analysis Plans), 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.

Salary, Benefits and Compliance

At Syneos Health, we provide an environment where Our People can thrive. Benefits may include a company car or car allowance, health benefits (Medical, Dental, Vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Paid sick time eligibility varies by location in accordance with state and municipal regulations. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range: $114,000.00 - $210,900.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on factors such as the candidate’s qualifications, skills, and proficiency for the role.

Summary

The Associate Director, Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Mentors less experienced writers and oversees the medical writing activities of multiple compounds, serving as lead writer for individual summary documents.

Legal and Equal Opportunity

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. If you require reasonable accommodations to complete any part of the application process, please contact [e-mail].

Phone: [phone] | Fax: [phone] | Toll-Free: 866 462 7373