Główne cechy
- Forma zatrudnienia
- Pełny etat
Opis stanowiska
Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!Duties:
Managesregulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 Phase 4 spanning the therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease)
Ensures that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
Requirements:
Educational backround within life science area (pharmaceuticals, biotechnology, biology, chemistry)
Practical experience within regulatory affairs in the pharmaceutical industry in clinicaltrialssubmisions
Practical experience within clinical trails area
Understanding of Drug Development, Clinical Trial Authorization Applications and associated legal requirements is also a must
Advanced English communication skills (C1)
Strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
Strong impact and influencing skills
Offer:
Amibious and challenging position in a company that is one of the global med-tech leaders (sponsor)
Attractive salary
International and interdisciplinary cooperation
Access to company's know how and opportunities for professional development
Remote work
Permanent job offer.
Miejsce pracy: Polska, Mazowieckie, Warszawa
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