Principal Medical Writer – Regulatory Submission Documents

# **Principal Medical Writer – Regulatory Submission Documents**

Syneos Health® is a leading fully integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

## **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 a total rewards program.
– We are committed to building an inclusive culture where you can authentically be yourself. Central to this is our purpose — *Driven to Deliver* — which captures the passion of our colleagues to show up each day and shape solutions that can dramatically impact someone’s life.
– We are continuously building the company we all want to work for and our customers want to work with. When we bring together smart colleagues from across the world, we shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

—

# **Job Responsibilities**
– Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
– Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision.
– Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, 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.
– Adhere to established regulatory standards, including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style/formatting guides.
– Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
– Act as a peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper format.
– Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output and document needs.
– Interact and build strong working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs.
– Perform online clinical literature searches and comply with copyright requirements.
– Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and company staff.
– Mentor and lead less experienced medical writers on complex projects.
– Develop deep expertise on key industry topics and regulatory requirements.
– Work within budget specifications for assigned projects.

—

# **Qualifications**
– Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred.
– 3–5 years of relevant experience in science, technical, or medical writing.
– Experience working in the biopharmaceutical, device, or contract research organization industry required.
– Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
– Experience writing relevant document types required.
– Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with the AMA Manual of Style.

—

# **Necessary Skills**
– Strong presentation, proofreading, collaborative, and interpersonal skills.
– Strong project and time management skills.
– Strong proficiency in MS Office.
– Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information.

—

At Syneos Health, 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. Benefits for this position may include a company car or car allowance; medical, dental, and vision benefits; company match 401(k); eligibility for the Employee Stock Purchase Plan; eligibility to earn commissions/bonuses based on performance; and flexible PTO and sick time. Eligibility for paid sick time may vary depending on location. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

—

# **Salary Range**
**$95,000.00 – $175,700.00**
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency.

—

# **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 highly competitive and ever‑changing environment. Learn more at:
**http://www.syneoshealth.com**

—

# **Additional Information**
Tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks, duties, and responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered. Nothing herein should be construed as creating an employment contract. The company complies with all applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, including reasonable accommodations when appropriate.

—

# **Summary**

Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for regulatory submissions or internal use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring medical communication expertise.

These roles involve screening, analyzing, and summarizing additional data as needed; conducting systematic literature searches; preparing literature for new products; and revising existing medical communication. They review and analyze statistical outputs to prepare results‑based documents such as clinical study reports and development safety update reports. They also support regulatory engagement through briefing books and response documents.

## **Impact and Contribution**
P22‑level medical writers:
– Ensure clear and accurate completion of medical writing deliverables.
– Manage writing activities associated with individual studies.
– Coordinate activities across departments with minimal supervision.
– Lead resolution of client comments.
– Complete a wide variety of regulatory and scientific documents.
– Adhere to regulatory standards and templates.
– Coordinate quality and editorial reviews.
– Act as peer reviewers for scientific content and consistency.
– Review statistical analysis plans and output specifications.
– Build strong working relationships across functional teams.
– Conduct literature searches and comply with copyright requirements.
– Provide technical support, training, and consultation.
– Mentor less experienced writers.
– Develop deep expertise in industry and regulatory topics.
– Work within assigned project budgets.

—

# **Apply for This 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. We also encourage you to join our Talent Network to stay connected to additional career opportunities.