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

Syneos Health, Inc.; Nebraska; Remote; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Principal / Principal Medical Writer. The role involves leading medical writing deliverables, ensuring adherence to regulatory standards, and mentoring junior writers. Candidates should have significant experience in medical writing and a strong understanding of clinical documentation. This position is remote-friendly and offers a competitive salary range of $95,000 to $175,700.

Benefits

Career development opportunities

Supportive work culture

Comprehensive benefits package

Qualifications

• 5+ years of experience in medical writing with strong technical and regulatory knowledge.
• Experience working with clinical documentation and submissions.
• Ability to mentor junior writers and lead project teams.

Responsibilities

• Lead the completion of medical writing deliverables accurately.
• Prepare a variety of complex documents for studies and submissions.
• Adhere to established regulatory standards and client expectations.
• Coordinate quality reviews and manage documentation.
• Provide expert peer review and technical oversight.

Skills

Medical writing

Regulatory standards adherence

Client communication

Team collaboration

Statistical analysis

Mentorship

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-NE-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. 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.
• 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. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• 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.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives.
• Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections.
• Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.
• Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

What We Offer

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

EEO Statement

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. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [e-mail] One of our staff members will work with you to provide alternate means to submit your application.