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

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Principal / Principal Medical Writer. This remote position focuses on leading medical writing deliverables, ensuring clarity and compliance with regulatory standards. The role includes mentoring junior writers and collaborating with cross-functional teams. Competitive salary with benefits offered.

Benefits

Health benefits

401k company match

Flexible paid time off

Qualifications

• Strong expertise in medical writing and regulatory requirements.
• Proven experience managing complex writing projects with minimal supervision.
• Ability to mentor and lead less experienced writers.

Responsibilities

• Lead and coordinate medical writing activities for clinical documents.
• Ensure high-quality deliverables that meet client objectives.
• Mentor junior medical writers and facilitate their development.

Skills

Medical writing

Regulatory compliance

Data presentation

Team collaboration

Education

Advanced degree in related field

Job description

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

Updated: October 1, 2025
Location: USA-MN-Remote

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. Leads the resolution of comments from the client.

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%).

Syneos Health offers valuable benefits and a quality-of-life balance, including Health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO) and sick time.

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

Get to know Syneos Health

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.