Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred [...]

Syneos Health, Inc.; Indiana (PA); Remote; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Principal/Principal Medical Writer to lead complex medical writing deliverables. This remote role requires expertise in creating clinical documents following regulatory standards and strong leadership in medical writing activities. The position offers a competitive salary range of $95,000.00 - $175,700.00.

Benefits

Career development opportunities

Total rewards program

Supportive and engaged management

Qualifications

• Proven track record of managing medical writing deliverables.
• Experience in developing clinical documents and adhering to regulations.
• Ability to coordinate medical writing efforts with minimal supervision.

Responsibilities

• Lead the completion of complex medical writing deliverables.
• Manage individual study medical writing activities.
• Complete various clinical documents including protocols and reports.
• Advise clients on data presentation and production strategies.

Skills

Medical writing expertise

Knowledge of regulatory standards

Team leadership

Clear communication

Education

Advanced degree in life sciences or related field

Job description

Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred - Single Sponsor

Updated: October 1, 2025
Location: USA-IN-Remote
Job ID:25102046

Description

Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred - 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. Why? 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

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Leads team document reviews and reviews documents for technical issues.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.

What We Offer

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

Salary Range: $95,000.00 - $175,700.00

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.