Principal Medical Writer

Syneos Health, Inc.; Leeds; Remote; GBP 35,000 - 65,000; Full time

Job summary

Join a dynamic team at a leading biopharmaceutical solutions organization where your contributions will directly impact the success of therapies that change lives. This role offers the opportunity to mentor and lead medical writers, ensuring high-quality documentation that meets regulatory standards. Collaborate with passionate professionals in a culture that values diversity and personal authenticity. Your skills in writing, presentation, and understanding of clinical data will be essential in navigating complex projects and delivering exceptional results. Be part of a company where your work truly matters, and make a difference in the lives of patients worldwide.

Benefits

Career development and progression

Supportive line management

Technical training

Peer recognition program

Total rewards program

Qualifications

• Bachelor's degree with relevant writing experience or a degree in Social Sciences/English.
• Strong proficiency in English grammar and familiarity with AMA style guide.

Responsibilities

• Mentors less experienced medical writers and represents the department on clinical teams.
• Advises on data presentation strategies to meet client objectives and quality standards.

Skills

Effective presentation skills

Proofreading skills

Interpersonal skills

Understanding of FDA regulations

Understanding of ICH guidelines

Education

Bachelor of Science degree

Bachelor of Arts degree (Social Sciences, English or Communications)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Email

Internet

Job description

Updated: February 5, 2025
Location: United Kingdom-Europe - GBR-Home-Based
Job ID: 25001633

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

1. Mentors and leads less experienced medical writers on complex projects, as necessary.
2. Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
3. Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
4. Develops good working relationships with internal and external colleagues.
5. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
6. Develops or supports a variety of documents that include but are not limited to:
1. Clinical study protocols and clinical protocol amendments;
2. Clinical study reports;
3. Patient narratives;
4. Clinical development plans;
5. IND submissions and annual reports;
6. Integrated summary reports;
7. NDA and (e)CTD submissions;
8. Investigator brochures;
9. Clinical journal manuscripts, clinical journal abstracts, and client presentations.
7. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
8. Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
9. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
10. Performs on-line clinical literature searches, as applicable.
11. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
12. Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
13. Completes required administrative tasks within the specified timeframes.
14. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

What we’re looking for

1. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
2. Extensive knowledge of English grammar with a familiarity with AMA style guide.
3. Understanding of FDA and ICH regulations and guidelines strongly preferred.
4. Demonstrated effective presentation, proofreading, and interpersonal skills, ensuring a team-oriented approach.
5. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
6. Ability to demonstrate familiarity with principles of clinical research and 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 what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.