Clinical Operations Director

4 days ago


Klang, Selangor, Malaysia Healthcare Businesswomen's Association Full time

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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