Documentation Specialist (MedicalTechnical Writing) France FSP

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

We are seeking a Documentation Specialist (Medical/Technical Writing) to join a key Functional Service Provider program supporting one of our key sponsors.

As a Documentation Specialist (Medical/Technical Writing) you will work as an integrated member of the sponsor team supporting the preparation and coordination of clinical development documents including Clinical Trial Reports (CTRs) Clinical Trial Protocols (CTPs) and amendments Investigator Brochures (IBs) and updates biomarker reports and submission documents.

This role is ideal for a scientifically minded professional who enjoys working in a collaborative environment where accuracy organization and attention to detail are essential. You will support document development activities coordinate administrative processes and contribute to the delivery of high-quality clinical documentation that supports the advancement of innovative therapies.

Key Responsibilities

• Support the set-up and maintenance of clinical documents within the Electronic Document Management System (EDMS).

• Review document status and assist with document workflow activities within sponsor systems.

• Coordinate document timelines and support project teams by tracking key deliverables.

• Prepare meeting materials and attend trial team and submission meetings documenting actions and outcomes as required.

• Support the organization and documentation of kick-off meetings and Results Alignment Meetings.

• Draft sections of clinical documents and contribute to the preparation of tables figures and supporting content.

• Coordinate document review activities and support the collection and incorporation of stakeholder feedback.

• Assist with Quality Control activities and completion of required documentation.

• Support preparation of final document packages for review publishing and archiving activities.

• Complete technical and formatting checks for Investigator Brochures and related clinical documents.

• Maintain accurate records and documentation in accordance with sponsor procedures and SOPs.

Candidate Profile

Youll thrive in this role if you bring:

• Experience supporting documentation needs in medical/technical writing clinical documentation or related clinical research activities.

• Strong organizational skills and the ability to manage multiple document-related activities simultaneously.

• Excellent written communication and attention to detail.

• A collaborative approach and willingness to work closely with cross-functional teams.

• A patient-focused mindset and commitment to quality.

Required Qualifications

• Scientific degree and/or advanced scientific degree.

• 1-3 years of experience within a clinical environment supporting medical/technical writing documentation.

• Knowledge of ICH-GCP regulatory requirements and clinical trial processes.

• Experience working with document management systems and clinical development documentation.

• Strong communication organizational and problem-solving skills.

If this job does not sound like the next step in your career but perhaps you know someone who would be a perfect fit send them the link to apply.

We believe in flexibility growth and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.