The Associate Director of Medical Governance & Risk Management plays a crucial role in supporting the implementation of the unified governance framework for medical and patient-focused programs within our organization. This role involves facilitating GxP process roll-outs, supporting self-assessments and audits, managing CAPA, and guiding associates in quality issue management. The Associate Director will contribute to maintaining excellence in risk and quality management within Novartis Medical Affairs.Job DescriptionMajor accountabilities :
Support the implementation of the governance framework for medical and patient-focused programs, leveraging the Medical Excellence Governance Board (MEGB) for streamlined consultation and escalation.Connect local Medical Governance Leads (MGLs) with global experts within MEOG and GMA to enhance onboarding, skills, and communication.Assist in developing and executing self-assessments and controls, analyzing trends, and recommending improvements.Support audit processes, including preparation, conduction, and CAPA management, aligned with the quality audit plan.Guide and mentor associates in risk and quality issue management, ensuring proper investigation and CAPA resolution.Contribute to the development and update of GxP processes, policies, and guidelines.Stay informed on industry trends and compliance needs, ensuring adherence to regulations and guidelines, and monitor training compliance.Collaborate across functions to drive projects, foster ethical standards, and ensure high compliance.Work with Medical capabilities to ensure effective training and onboarding for MGLs, MEOG, and Medical Affairs staff.Participate in decision-making and project teams to achieve outstanding results.Demonstrate leadership and cross-functional collaboration skills.Utilize strategic and organizational skills to support governance framework implementation.Act as a liaison between scientific and business functions, promoting collaboration.Align medical governance and risk management with organizational strategies.Key performance indicators :
Maintain Quality Management System standards;
identify and mitigate risks;
ensure continuous process improvement.Achieve no critical findings in health authority inspections and internal audits due to effective governance.Minimum Requirements :
Work Experience and skills :
Bachelor's degree in Medical Sciences, Life Sciences, Medicine, or related fields.At least 10 years of experience in the pharmaceutical industry, with exposure to medical affairs, clinical development, compliance, quality assurance, risk management, or regulatory areas. Multi-area experience preferred.Strong knowledge of GxP, medical guidelines, health authority requirements, and ICH guidelines.Experience with self-assessments, audits, and CAPA management.Proven ability in risk management and collaborative problem-solving.Experience working with global teams and cross-functional collaboration, including regional or country roles.Track record in driving change, capability building, and fostering a culture of ethics and compliance.Effective leadership, interpersonal, negotiation, and conflict resolution skills.Proactive with contingency planning skills.Strong strategic, analytical, organizational, and planning skills.Ability to work independently, incorporate stakeholder feedback, influence decisions, and lead project teams.Facilitation skills to bridge scientific and business functions.Business acumen to align governance with organizational goals.Languages :
Fluent in English (spoken and written).Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Disease Area Expertise, Product Launches, Product Strategy, RWE, Regulatory Compliance, Research Methodologies, and more.J-18808-Ljbffr
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