Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health, Inc.; Montrouge; Sur place; EUR 97 000 - 180 000; Plein temps

Résumé du poste

A leading healthcare solutions company seeks a Senior Principal Medical Writer to develop regulatory documents for global submission. The ideal candidate has extensive experience in clinical writing, project management, and mentoring junior staff. Responsibilities include overseeing medical writing projects, collaborating with cross-functional teams, and ensuring adherence to regulatory standards. Compensation ranges from $114,000 to $210,900, with benefits such as health coverage and flexible time off.

Prestations

Company car or car allowance

Health benefits (medical, dental, vision)

Company match 401(k)

Employee stock purchase plan

Flexible paid time off

Qualifications

• Broad understanding of clinical research processes and regulatory document standards.
• Experience in developing clinical documents for regulatory submissions.
• Ability to mentor less experienced writers.

Responsabilités

• Develop regulatory documents for submission to global agencies.
• Manage medical writing projects and timelines.
• Participate in cross-functional meetings for medical writing deliverables.
• Review documents associated with projects.
• Define and write standard operating procedures for document preparation.
• Mentor junior medical writing staff.

Connaissances

Regulatory document development

Project management

Mentoring

Cross-functional communication

Process improvement

Scientific writing

Description du poste

Senior Principal Medical Writer – Regulatory – Oncology – Single Sponsor

Updated: October 2, 2025
Location: Montrouge, 1, France

Job Description

Senior Principal Medical Writer – Regulatory – Oncology – Single Sponsor

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and communication 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 process(es) 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.
• Participate in cross‑functional process improvement initiatives.
• Define and write standard operating procedures and best practices for efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Qualifications

The Associate Director, Principal Medical Writer I 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 [IBs], Clinical Study Reports [CSRs], and 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. Reports to a Director of Medical Writing or above.

Benefits & Compensation

Salary Range: $114,000.00 – $210,900.00
Benefits may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), eligibility to participate in employee stock purchase plan, eligibility to earn commissions/bonus, and flexible paid time off (PTO) and sick time. Eligible for paid sick time per applicable state and municipal regulations.

EEO Statement

We are 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. The Company is also committed to compliance with the EU Equality Directive and is committed to equal employment opportunity for all employees and applicants.