Operations - Regulatory Operations Senior Analyst
- Ważna jeszcze 21 dni (do 16.06.2018)
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Regulatory Operations Senior Analyst
Miejsce pracy: Warszawa
What will you do?Accenture’s Accelerated R&D Services (ARDS) bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance functions around the globe. Mostly, you will be:
Coordinate submission documentation (new and lifecycle submissions). Leverage publishing team as appropriate.
Review and validate submission technical.
Coordinate final submission review and approval by appropriate stakeholders.
Finalize and dispatch submission to client affiliates or Health Authorities as required.
Create and maintain initial and lifecycle events in regulatory information management (RIM) system.
What we expect from you:
Experience in publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Health Authorities in eCTD, NeeS, eSub or paper formats.
Knowledge of regulatory submission requirements and understanding of the nuances of different submission components.
Experience with publishing software and tools used throughout the pharmaceutical industry and in regulatory information management (RIM) systems.
Minimum 2 years of experience in an area of expertise (e.g., regulatory documentation publishing, RIM data management).
Knowledge in handling registrations and maintenance of pharmaceutical products from a regional or local perspective.
What we can offer:
Support for your career and competences development – learning from colleagues, courses and trainings, allowing you to boost your skills and become #BEFUTUREPROOF
Using foreign language and new technology solutions daily, cooperating with various Clients
CSR activities and rich social life – Book Club, International Cuisine Club, Accenture Runners Club, family events, cultural meetings, photography classes, climbing, soccer, swimming
Full work comfort – private medical care, life insurance, access to MyBenefit platform
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