Beschreibung
Job Responsibilities:
Contribute to the action plan to implement ISO IDMP standards within the company.
Contribute to the RIM System Delivery and Data Migration Workstreams to ensure activities are on-track and meet IDMP requirements in the new RIM system.
Contribute to the review of draft ISO IDMP requirements/guidance documents with internal alignment
Works with relevant Line Functions to communicate ISO IDMP requirements by providing training sessions to RA 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 HA requirements (planning, compilation, publishing and submissions to HAs according to the right format).
You will work with external Business Consultancy according to company needs.
Key Skills:
Fluency in English as a business language (additional language is an asset).
Requirements:
Life Science Degree (eg Chemistry, Pharmacy, Biology), or MBA (Project Management).
Prior experience in using RIM systems and publishing related software/tools.
A minimum of 3-5 years of experience in Regulatory submissions in Europe (post-marketing experience in CMC, Labeling variations, xEVMPD).
A minimum of 3-5 years of experience in Project management and Submission management.
Good knowledge of the drug development process and submission guidelines.
You will have good knowledge of publishing processes.