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Medical Advisor

East Hanover, NJ 07936

Posted: 05/30/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 568386 Is job remote?: No Country: United States

Job Description

Pay rate: $47 - $82
NYC and CO candidates may not be considered 

The Associate Director, for the Oncology Office of Grants and Education (OGE), is responsible for supporting the Head of OGE with the development of medical education plans, assist in providing direction and oversight for all continuing medical education initiatives, and implementing Novartis policies and procedures in alignment with external regulations.

This position entails effectively interfacing and collaborating with key stakeholders including: Ethics & Compliance, Legal, Medical Affairs, Clinical Research, Oncology Patient Advocacy, US Pharmas Grant Office (NOGE), and Finance. Responsibilities include: Develop, maintain and execute comprehensive medical education plans for assigned therapeutic areas. Serve as OGE lead on cross-functional medical disease teams to align medical education plans with disease-related strategies. Timely and compliant internal review and management of all grant applications received through medical education grants portal, for all steps from submission through to program reconciliation, including reviewing based on scientific/medical merit and compliance assessment and potential government reporting, and liaising with grant requestors and recipients. Support the development of the annual OGE budget for all independent educational grants and medical sponsorships; manage budget for assigned therapeutic area(s) ensuring that funding is allocated within budget and according to medical education plans. Monitor, review, maintain documentation and provide accurate reporting to meet compliance, legal requests and government requirements as required related to supported independent medical education activities. Execute ongoing evaluation / monitoring of supported educational initiatives and associated Educational Providers to ensure agreement with approved grant, scientific/medical accuracy, and balance/bias. Conduct on a continuous basis an educational gap analysis to identify unmet medical needs. This includes the analysis of the medical literature, scan of the external educational landscape, review of outcomes of supported programs, information gathered by other functions within Medical Affairs and related departments. Based on findings, creates the annual educational strategy and educational parameters for the therapeutic area. Liaise in a compliant manner with external stakeholders regarding their organizational initiatives & educational programs, notification of grant decisions, awareness of timelines, budget schedules, receipt of outcomes and required government reporting. Accountable for management of disease related grants budget including phasing, grant payments, and reconciliation. Participate in cross functional teams to ensure department and organization comply with all internal and external requirements (i.e. Sunshine, CIA, ACCME, Novartis policy). Ensure 100% compliance with OGE SOPs, regulatory, industry, and OIG guidelines. Receive, review and render timely dispositions of Medical Sponsorship requests. Version 2, 28Sep2020 Prepare and present grants to the Grants Review Committee (GRC); serve as chair for GRC in directors absence. Demonstrate strong medical and scientific knowledge and planning related to assigned therapeutic area(s). Proactively stay abreast of emerging compliance, regulatory, educational and industry trends; update colleagues and medical teams on a real-time basis. Coach and mentor colleagues regarding best practices and business fundamentals; identify areas to enhance OGE efficiencies.

Position Requirements HCP: RN / PharmD / PhD - Life Sciences / MD highly preferred

MS and/or BS required, preferably in a Scientific Discipline Minimum of 5 to 7 years of experience Prior experience in oncology and/or pharmaceutical/med device grants department preferred Understanding of PhRMA, OIG, and ACCME guidelines and policies as well as other regulatory, legal, ethics/compliance guidelines/regulations
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