Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based

Syneos Health, Inc.; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading biopharmaceutical solutions organization is seeking a Principal Medical Writer for remote work. This role entails developing regulatory documents for submission to global authorities, managing writing projects, and collaborating with cross-functional teams. The ideal candidate will have a relevant degree, a strong understanding of clinical research processes, and excellent project management skills. This position offers an opportunity to impact patient lives positively by ensuring timely and high-quality document delivery.

Prestations

Career development opportunities

Total rewards program

Supportive work culture

Responsabilités

• Develop regulatory documents for submission to global regulatory agencies.
• Manage medical writing projects and timelines.
• Participate in cross-functional meetings to provide input on deliverables.
• Review other documentation associated with projects.

Connaissances

Regulatory document development

Project management

Cross-functional collaboration

eCTD submission experience

Clinical research understanding

Formation

Relevant degree in life sciences or related field

Description du poste

Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based

Updated: December 3, 2025
Location: Montrouge, 1, France
Job ID:25103691-OTHLOC-3527-2DR

Description

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 puts the customer and the patient at the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and 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, innovate as a team, and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies so we can change lives.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health?

• We are passionate about developing our people, offering career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. That culture unites us globally and we are dedicated to caring for our people.
• We continuously build the company we all want to work for, and our customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels at home.

Job Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards where applicable, and in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams as necessary) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
• Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• eCTD submission experience preferred.
• The role does not require mentoring junior writers, managing external vendors, or participating in standard operational procedures or other department initiatives. Writers are located on both EU and US sides and work globally as a team.

Get to know Syneos Health

Over the past five 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 initiative and challenge the status quo in a competitive and ever‑changing environment. Learn more about Syneos Health at http://www.syneoshealth.com.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company, at its sole discretion and without 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 will determine what constitutes equivalent to the qualifications described above. Further, nothing herein should be construed to create an employment contract. The language herein fully complies 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 recruitment and employment of its employees. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate, to assist employees or applicants in performing the essential functions of the job.

Summary

• The Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally.
• Provides strategic direction to cross‑functional project teams with minimal oversight to ensure that clinical documents (e.g., Investigators' Brochures, Clinical Study Reports, marketing authorization submission documents) accurately and consistently present key data‑driven clinical messages in accordance with program goals and regulatory requirements.
• Writes or provides direction and leadership to other writers to ensure the timely delivery of high‑quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.
• Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
• Has a broad understanding of clinical research processes and global regulatory document standards.
• Mentors less experienced writers.

Discover what our more than 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. Selecting us as an employer secures a career in which you’re guaranteed to:

Syneos Health® (NASDAQ:SYNH) 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. 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 diverse, equitable and inclusive culture.