Project Manager Regulatory Ecosystems

il y a 1 mois

Les Ulis, France IPSEN Temps plein

**Title**:
Project Manager Regulatory Ecosystems

**Company**:
Ipsen Innovation (SAS)

In close collaboration with the Regulatory Systems Owner and Regulatory System Support and within the framework to leverage and improve the Regulatory Ecosystems
- Manage systems trainings
- Participation in tool’s evolution
- Oversight manager provider
- Manager systems improvement project

**Activities List**

**Main Responsibilities**

**Main Tasks**
- ** Manage trainings**
- Get full knowledge of the systems configuration and processes
- Update existing trainings
- Manage trainings evolution with the service provider
- Develop advanced specialized trainings
- ** Participation in tool’s evolution**

Participate to the regulatory ecosystems change management in support to the System Owner
- Diagnose the systems and propose improvements ways
- Quick win, supportive material
- Interviewing key stakeholders to harmonize processes
- Ensure the launch and follow-up of the regulatory impact assessment and validation by “change control board” and validate the implementation of the evolution
- Drive / Execute informal and formal tests
- Develop and/or Execute Business qualification testing scripts
- Support system validation activities ensuring high quality user acceptance/ performance qualification testing scripts and providing review capability for operation qualification scripts
- ** Oversight Service Provider**

In close collaboration with the systems owner:

- Oversight day to day activities of the service provider
- Answer level 2 questions from users
- Follow up activities with routines meeting.
- ** Project Management**
- Launch and lead planification
- Launch and lead Systems Super User Organization
- Propose and participate in systems improvement project

**Experience / Qualifications**

**Ideal**:

- At least 4 years professional experience, including 1-year experience in Corporate Regulatory Affairs
- Experience in learning & training Management.
- Experience within systems development & validation.
- French & English language fluent.
- **Minimum**:

- Degree in life science discipline including background on medicinal products (pharmacist, life science engineer, software & physiology engineering) or equivalent professional experience
- At least 2 years professional experience, including 1-year experience in Regulatory Affairs or IT
- Tact and helpful attitude
- Good organizational skills, interpersonal and negotiation skills
- Good written and oral communication skills
- Professional English, written and oral, if not mother tongue

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