Regulatory Operations Publisher

Veristat; France; Hybride; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading clinical research organization in France is seeking a Regulatory Operations Publisher to support the Medical Writing and Regulatory Affairs team. This role involves the finalization and publishing of regulatory documents for electronic submissions. The ideal candidate has a Bachelor’s degree and 1-2 years of experience in regulatory publishing, along with proficiency in various publishing software. The company promotes a flexible, inclusive culture with a remote workforce.

Prestations

Flexible and inclusive culture

Remote work options

Qualifications

• At least 1-2 years of experience in regulatory publishing.
• Proficient in publishing software and advanced formatting.
• Ability to communicate and collaborate in project teams.

Responsabilités

• Support finalization and publishing of regulatory documents.
• Coordinate internal publishing activities.
• Perform quality control review tasks and administrative duties.

Connaissances

Regulatory publishing experience

Proficiency in Adobe Acrobat

Excellent writing skills

Attention to detail

Strong verbal communication

Formation

Bachelor’s Degree

Outils

eCTDmanager

DocuBridge

eCTDXpress

Microsoft Word

Description du poste

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The Regulatory Operations Publisher supports the Medical Writing and Regulatory Affairs team with the finalization and publishing of regulatory documents for electronic submission. S/he plays a crucial role in representing the regulatory operations group in publishing pivotal research documentation, and its timely delivery therein.

The Regulatory Operations Publisher coordinates internal publishing activities, and provides training and support on publishing and formatting processes and software. S/he also performs quality control review tasks and administrative duties as requested.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

105+ approved therapies for marketing applications prepared by Veristat

480+ oncology projects in the past 5 years

350+ rare disease projects delivered in the past 5 years

Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Learn more about our core values here!

What we look for

Bachelor’s Degree with at least 1-2 years of experience in regulatory publishing in a contract research organization (CRO), pharmaceutical, biotechnology, or other clinical setting.

Proficiency in Adobe Acrobat, ISIToolbox, publishing software (e.g., eCTDmanager, DocuBridge, eCTDXpress, etc.) and advanced formatting using Microsoft Word styles and templates, including EndNote software.

Excellent writing skills (eg, English usage), a keen attention to detail, and strong verbal and interpersonal communication skills.

Proficiency with medical and statistical terminology.

Ability to communicate and collaborate effectively in project teams.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

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Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.