Principal/Senior Medical Writer - Regulatory - Oncology - North America/United Kingdom and Irel[...]

Syneos Health, Inc.; New Hampshire; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical solutions organization is looking for a Principal/Senior Medical Writer to manage projects and mentor writers. Responsibilities include developing clinical documents and collaborating across departments. Candidates should have a relevant Bachelor's degree and strong communication skills. A remote position based in New Hampshire with minimal travel required.

Benefits

Career development opportunities

Total rewards programs

Supportive management

Qualifications

• Extensive knowledge of English grammar and FDA/ICH regulations and guidelines.
• Demonstrated independence with strong presentation and proofreading skills.
• Ability to interpret and present clinical data and other complex information.

Responsibilities

• Mentor and lead less experienced medical writers.
• Manage medical writing activities for individual studies.
• Develop clinical study protocols and amendments.

Skills

Strong presentation skills

Proofreading

Interpersonal skills

Leadership skills

Education

Bachelor of Science or Bachelor's of Arts (Social Sciences, English, or Communications preferred)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Email

Internet

Job description

Overview

Principal/Senior Medical Writer - Regulatory - Oncology - North America/United Kingdom and Ireland (homebased)

Updated: October 2, 2025
Location: USA-NH-Remote
Job ID: 25999959

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.

Our Clinical Development model centers on the customer and the patient, with a focus on simplifying and streamlining work to be easier to work with and for. Collaborate with passionate problem solvers as part of a team to help customers achieve their goals, whether in a Functional Service Provider partnership or a Full-Service environment. 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 committed to developing our people through career development, training, and recognition; supportive management; and total rewards programs.
• We embrace a Total Self culture—authenticity and belonging are values we uphold globally.
• We foster diversity of thought, backgrounds, and perspectives to create a sense of belonging for all.

Responsibilities

• Mentor and lead less experienced medical writers on complex projects as necessary.
• Act as lead for assigned writing projects.
• Manage medical writing activities for individual studies, coordinating within and across departments with minimal supervision.
• Develop or support a variety of documents, including:
  • Clinical study protocols and amendments
  • Clinical study reports
  • Patient narratives
  • Clinical development plans
  • IND submissions and annual reports
  • Integrated summary reports
  • NDA and (e)CTD submissions
  • Investigator brochures
  • Clinical journal manuscripts, abstracts, and client presentations
• Identify and propose solutions to issues during writing, including escalation when appropriate.
• Review statistical analysis plans and specifications for content, grammar, format, and consistency.
• Collaborate with data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Serve as peer reviewer on internal review teams, providing comments on drafts and final documents.
• Adhere to regulatory standards (ICH-E3), company SOPs, client standards, and approved templates; deliver projects on time and on budget.
• Perform online literature searches as applicable.
• Maintain familiarity with current industry practices and regulatory requirements for medical writing.
• Be aware of budget specifications for assigned projects, working within budgeted hours and communicating changes to leadership.
• Complete required administrative tasks within specified timeframes.
• Perform other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

What we’re looking for

• Bachelor of Science with relevant writing experience or Bachelor of Arts (Social Sciences, English, or Communications preferred) with relevant scientific/medical knowledge.
• Extensive knowledge of English grammar and FDA/ICH regulations and guidelines; familiarity with AMA style guide.
• Demonstrated independence with strong presentation, proofreading, interpersonal, and leadership skills; ability to work in a team-oriented environment.
• Proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to interpret and present clinical data and other complex information.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter your role, you’ll take initiative and challenge the status quo in a competitive and dynamic environment.

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 accommodation to complete any part of the application process, contact [e-mail].

Additional information: The company reserves the right to assign additional tasks and responsibilities. This notice is intended to comply with applicable laws and policies. Details may vary by country and role.