Global Medical Affairs (GMA) Medical Review Committee (MRC) Lead

Job description

Job Description

• Support the MRC Chair and/or Virtual MRC Chair in the conduct of MRC meetings for the review of all Oncology Medical Affaris (OMA) concept sheets for Novartis Sponsored Studies, both Medical Affairs and Global Value Access (GVA)/Health Economics and Outcomes Research (HEOR), Investigator Initiated Trials (IITs), Cooperative group studies, and Managed Access Programs across Franchise MRCs and Virtual MRC
• In close collaboration with Franchise Head, perform preliminary validation (redundancy checks, etc.) of concept sheets
• Ensure MRC meeting administrative activities are executed in a compliant manner (including but not limited to)
I. Meetings are scheduled in a timely manner
II. Required attendees are invited
III. Ensure action items defined during the meeting are captured with appropriate action owners
IV. Availability, consistency and completeness of Meeting Minutes
• Develop and drive the alignment on operational activities across key stakeholders associated with the OMA MRC process at the Global, Regional and Country level
• Provide MRC updates, as applicable, to Global Medical Affairs (GMA) and OMA Leadership
• Support annual reviews and all change management of MRC/Project Review Committee (PRC) Oncology Business Unit Guidance document
• Provide the operational oversight of the IIT portfolio across OMA through KPI and metrics
• Report on key metrics and KPIs as relevant on timely fashion
• Identify trends on the outcomes of metrics and KPIs and develop mitigation plans as required.
• Participate in cross-functional IIT Governance Board and IIT related initiatives
Position Title

Global Medical Affairs (GMA) Medical Review Committee (MRC) Lead

Desired profile

Minimum requirements

• Degree or equivalent education/degree in life science/healthcare preferred
• Fluent English (oral and written)
• ≥5 years of pharmaceutical/CRO clinical research experience, preferably in global matrix environment
• ≥2 years IIT experience required
• Proven ability to work independently
• Established knowledge of clinical development process, Good Clinical Practice (GCP) and clinical project management. Novartis experience in these areas is preferred.
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills
• Ability to influence without authority in highly matrixed organization
• Organizational awareness, including experience working cross-functionally and in global teams.
• Proven track record in clinical operations process improvement(s) or equivalent
• Experience in developing effective working relationships with internal and external stakeholders
• Proactive team player with an ability to act in a forward-thinking and collaborative manner
• Ability to proactively identify and propose practical operational solutions to address forecasted and unforecasted business issues
Job Type

Full Time
Country

Switzerland
Work Location

Basel
Functional Area

Research & Development
Division

Oncology
Business Unit

ONCOLOGY
Employment Type

Regular
Company/Legal Entity

Novartis Pharma AG