Alternance - Regulatory Operations [France]

 

Title:

Alternance - Regulatory Operations

Company:

Ipsen Innovation (SAS)

Job Description:

Ipsen is pleased to open a 12-month apprenticeship (alternance) in the Global Regulatory Affairs, Data & Systems team! We are looking for a motivated Regulatory Affairs & Engineering/IT double degree student to work in our R&D office in Les Ulis, France.

In close collaboration with Regulatory Data & Integrity Team, Director Data & System, Regulatory System Owner, System Team & IT Team and within the framework of a project to improve the user experience of Regulatory people and the improvement of our data management and analysis processes:

• Identify ways of improvement of data management

• Participate in the development, implementation, and promotion of the tool in link .

• Analyze data and define KPI.

Identify ways of improvement of data management

• Analyze current system and capabilities

• Analyze current processes and how to ease it.

• Establish improvement to ensure the appropriate level of Regulatory Information tracking and validation

Participate in the development, implementation, and promotion of this improvement

• Participate to the Regulatory Information Management System (RIMS) Changes in support to the Regulatory Systems Owner:

• Design and configure improvement

• Execute informal and formal tests

• Develop and/or Execute Business qualification testing scripts

• Implement new functionalities

• Assess and manage impact on processes

• Manage users training

Analyze data and define KPI

• Analyse current KPIs and all available date

• Define new KPIs to identify and set RIMS improvement

• Establish new KPIs to monitor to assess the benefits of the changes

GRQ and GRQ Trainee Academy active team member

• Attend/Present at GRQ 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 GRQ Trainee Academy (specific program designed to provide a framework for the GRQ 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.

EHS Missions

• Respect the regulations and EHS procedures in force.

• Participate in the EHS performance of the site by reporting risks, malfunctions or improvements.

• Participate in mandatory EHS training.

Experience / Qualifications

Ideal:

• Experience in regulatory system evolution / system administration (URS, configuration, migration document)

• Experience in data analysis and tool such as Excel / Power-BI / Access / R…

• French language fluent

Minimum:

• Ongoing master in life science discipline (pharmacist, life science engineer, software & physiology engineering)

• Tact and helpful attitude

• Good organizational skills, interpersonal, meticulous, and methodical

• Good written and oral communication skills

• Professional English, written and oral, if not mother tongue

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.