Clinical Operations Director
4 days ago
About the Position
We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. 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.
Required Skills
- Strong regulatory affairs expertise
- Excellent analytical and problem-solving skills
- Ability to communicate effectively with stakeholders
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