Apprenti Réglementaires

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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WHAT - Summary & Purpose of the Position

As a Regulatory Operations apprenticeship you will support projects aimed at optimizing regulatory data management by working closely with key teams such as Global Regulatory Local Regulatory and Regulatory Operations.

Your role will involve enhancing regulatory data tracking including IDMP related activities within the Regulatory Information Management (RIM) system and contributing to process improvements to ensure efficient data entry and management.

WHAT - Main Responsibilities & Technical Competencies

Main tasks

• Collaborate with the regulatory team to understand their processes workflows and requirements.
• Conduct research and analysis to identify opportunities to improve regulatory processes and datamanagement practices.
• Support the implementation of solutions that enhance regulatory compliance streamline workflows and improve dataentry efficiency.
• Assist in data enrichment cleaning and quality control activities to ensure consistency and accuracy of RIM data including IDMPrelated data.
• Contribute to the development and maintenance of procedures work instructions and project documentation.
• Support the preparation of training materials and contribute to enduser training sessions.

GRA Trainee Academy active team member

• Attend/Present at GRA knowledge sharing meetings.
• Attend Ipsen internal events (presentations external speakers forums webinars celebrations )
• Ensures adequate reporting of his/her activities and participates to various meetings depending on project assignments.
• Be an active member of the GRA Trainee Academy (specific program designed to provide a framework for the GRA interns and apprentices only): attending proposed trainings prepare webcast share experience build network site visits (if possible) get exposure to senior management. Provide feedback and participate in Trainee Academy further development and visibility.

HOW - Behavioural Competencies Required

• Good analytical skills & organizational skills
• Good communication and interpersonal skills
• Good written and oral communication skills

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Knowledge in Regulatory affairs
• Knowledge in Regulatory Database management
• Proficiency in Microsoft Office especially Excel and PowerPoint

Education / Certifications (essential):

• Ongoing master in life science discipline (pharmacist life science engineer)

Language(s) (essential):

• Professional English written and oral

Language(s) (preferred):

• French language fluent