US-NJ, Head of Medical Operational Excellence 236906BR-MZ
Head of Medical Operational Excellence
Global Drug Development
CMO & PATIENT SAFETY GDD
East Hanover, NJ
Research & Development
Responsible for driving continuous process improvement of medical safety processes, as well as medical safety compliance, quality, and metrics. Development and maintenance of the medical function processes incl. SOPs. Ensure appropriate Argus processes are in place to reach high quality MR and high quality cases in Argus. Strategically lead and drive compliance standards including inspection readiness for Medical Safety. Coordinate activities with other Global Line Functions in CMO & PS and with the external vendors to ensure Medical Safety responsibilities are consistently met with a high level of quality and timeliness.
1. Drive continuous process improvement of Medical Safety processes and standardize the processes across therapeutic areas. 2. Responsible for the development and maintenance of global processes and guidelines, in accordance with global safety regulations, relating to the Medical Safety function including through the ad hoc participation at the Process Review Board. 3. Drive process improvement to ensure high quality deliverables within Medical Safety. 4. Act as a Subject Matter Expert and person of contact for Argus MR case quality issue and Argus MR processing issues. Work together with the vendors and provide training to the vendors for case processing improvement as required. 5. Ensure appropriate Argus processes are in place to reach high quality MR and high quality cases in Argus. 6. Collaborate with the vendors and provides training as necessary to ensure high quality of the deliverables, in particular for aggregate reports (e.g. PSURs). 7. Responsible for assuring conformity with CMO & Patient Safety procedures and processes and with regulatory requirements. 8. Establish processes and collaborates with other Novartis global line functions to develop synergies and ensure the fulfillment of all Medical Safety responsibilities. 9. Track Medical Safety compliance, metrics and CAPAs. 10. Responsible for tracking Investigator notifications, SMT minutes, SSPT maintenance, SMaRT updates, and MSRB scheduling compliance. 11. Act as a Subject Matter Expert for the Medical Safety function and lead or be a key contributor in global Novartis and CMO & Patient Safety work streams and initiatives (for instance Argus 8, case workflow initiatives, case-processing related initiatives, case MR quality improvement). 12. CSR/TPSR Safety Review process owner, including coordinating the support of the vendor. 13. Provide initiative support for Medical Safety. Coordinate the SMEs participation for each initiative and identify SMEs needed for new and ongoing initiatives and working groups. 14. Identify significant Medical Safety function gaps and training needs; establish effective training programs with evaluation of effectiveness for Medical Safety.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Advanced degree or equivalent education/degree in life science/healthcare. MD, MBBS, PharmD, PhD preferred. English Required professional experience: 8 years in drug development in a major pharmaceutical company (of which 5 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position); Demonstrated people management experience (direct/matrix). Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team. Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills; Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure Quality oriented; Good planning, organizational and computer skills.
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