GMA MRC Lead Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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GMA MRC Lead job in East Hanover

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Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  240056BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  East Hanover
Map: 
09/05/2018

Description
The GMA MRC Lead is responsible for driving and strengthening the Oncology Medical Affairs (OMA) Medical Review Committee (MRC) process. This position requires an in depth understanding of OMA compounds/disease areas and strong ability to build partnerships with key stakeholders at the global, regional and local level throughout OMA and Global Value Access (GVA)/Health Economy and Outcome Research (HEOR).

The GMA MRC Lead has holistic oversight and serves as the primary driver of all activities related to the OMA Medical Review Committee. The GMA MRC Lead will track KPIs and Metrics of the operational management of the Investigator Initiated Trials (IITs) portfolio across OMA.

Major Accountabilities

•Support the MRC Chair and/or Virtual MRC Chair in the conduct of MRC meetings for the review of all OMA concept sheets for Novartis Sponsored Studies (both Medical Affairs and GVA/HEOR), 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)
iMeetings 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 GMA and OMA Leadership
•Support annual reviews and all change management of MRC/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
•Participate in co-authoring/ review of IIT related SOPs/GOPs as applicable
Education:
Degree or equivalent education/degree in life science/healthcare preferred

Experience:

•≥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, 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

•Compliance oriented
ref: (240056BR)
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