Beschreibung
Project Manager IDMP NOVJP (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- As a member of the Regulatory Stategy & Intelligence (RS&I) Worksteam contribute to the action plan to implement ISO IDMP standards within the company
- Contribute to the System Delivery and Data Migration Workstreams to ensure activities are on-track and meet IDMP requirements in the new Regulatory Information Management system
- Contribute to the review of draft ISO IDMP requirements/guidance documents with internal alignment
- Work with relevant Line Functions to communicate ISO IDMP requirements by providing training sessions to Regulatory Affairs colleagues, COs or X-functionally and via written communication such as Newsletters, information e-mails, etc.
- Support process changes at global and local levels to ensure compliance with Health Authorities requirements (planning, compilation, publishing and submissions to Health Authorities according to the right format)
- Work with external Business Consultancy according to company needs
Main qualifications
- Life Science Degree (e.g. Chemistry, Pharmacy, Biology), or MBA (Project Management)
- Fluency in English as a business language. Additional language is an asset
- Profound experience in the Pharmaceutical Industry mainly in a regulatory environment and closely related areas (e.g. Clinical Development, GxP, Regulatory CMC, QA, Project Management)
- Good understanding of Computerized Systems Validation
- Good knowledge of Novartis processes (Regulatory, Pharmacovigilance, Manufacturing, Labelling), Compliance and Change Management requirements
- Experience and ability to work in matrix cross-functional environment
Main advantages:
- A very renowned company
- Flat hierarchies
- Interesting tasks in a multinational environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Sonja Lentz
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