Governance Lead
4 days ago
About this Opportunity
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist. In this role, you will be responsible for leading the end-to-end medical governance of regulated activities in alignment with Medical Affairs strategy and priorities.
Main Responsibilities
- Lead the End-to-End medical governance of regulated activities (Interventional and NIS/RWE, IIT, MAP, RC), in alignment with Medical Affairs strategy and priorities.
- Act as the country expert on MA processes, Novartis standards, and country regulation.
- Monitor adherence to Novartis processes, standards, and country regulations.
- Support data quality/integrity in country MA.
- Coordinate processes for medical information services, aligning CPO needs with Novartis requirements, including appropriate handling of potential adverse event and product complaint reporting.
What We're Looking For
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment
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