Principal Medical Writer (Regulatory Submissions)

Syneos Health, Inc.; Leeds; Remote; GBP 40,000 - 80,000; Full time

Job summary

Join a forward-thinking organization as a Principal Medical Writer, where your expertise in regulatory submissions will make a significant impact. This role involves mentoring junior writers, managing medical writing activities, and ensuring adherence to regulatory standards. Collaborate with a diverse team to produce high-quality documents that facilitate the delivery of life-changing therapies. With a commitment to professional development and a culture that values authenticity, this opportunity offers a chance to grow while contributing to meaningful projects. Embrace the challenge and make your mark in the biopharmaceutical industry!

Benefits

Career development opportunities

Peer recognition programs

Total rewards program

Supportive line management

Diversity and inclusion initiatives

Qualifications

• Bachelor's degree with relevant writing experience or preferred in Social Sciences, English, or Communications.
• Extensive knowledge of English grammar and familiarity with AMA style guide.

Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Develop and support a variety of documents including clinical study protocols and reports.

Skills

English grammar

Presentation skills

Proofreading

Interpersonal skills

Clinical research principles

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

Principal Medical Writer (Regulatory Submissions)

Updated: January 31, 2025
Location: United Kingdom-Europe - GBR-Home-Based
Job ID:25001444

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 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.

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.

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.

Syneos Health is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a