Senior Principal Medical Writer

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Medical Writer for remote work. This role involves developing regulatory documents, managing medical writing projects, and ensuring adherence to guidelines. Candidates should have experience in regulatory writing and project management, with opportunities to mentor junior staff. Competitive salary range from $114,000 to $210,900 with attractive benefits including health insurance and 401(k) matching.

Benefits

Health benefits (medical, dental, vision)

401(k) match

Flexible paid time off

Qualifications

• Experience developing regulatory documents for global submissions in accordance with ICH guidelines.
• Ability to manage medical writing projects and timelines.
• Proven capacity to mentor junior staff.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally.
• Manage medical writing projects and timelines.
• Participate in cross-functional meetings for medical writing deliverables.

Skills

Regulatory document development

Medical writing project management

Cross-functional collaboration

Mentoring

Job description

Overview

Updated: September 24, 2025
Location: USA-IN-Remote
Job ID: 25101798

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 centers the customer and patient experience, and we aim to simplify and streamline work to better support our teams and customers.

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 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 belongs.

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 processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., 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.

Compensation and Benefits

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 various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) match, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, flexible paid time off (PTO) and sick time. Paid sick time eligibility varies by location; Syneos complies with applicable paid sick time requirements.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We support a diverse, equitable and inclusive culture.

Equal Employment 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. Reasonable accommodations are available for applicants with disabilities. If you require assistance, please contact [e-mail].

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