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Job Description

Location - Remote but preferably close to Boston as monthly trips would be required.

OBJECTIVES:

• Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates.

• Contributes to and implements the engagement strategy among R&D, Business Units and affiliates and Quality to ensure a global framework and robust quality systems are in place for the transition of R&D pipeline to the commercial space.

• Drives a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility.

• Establish and maintain relationships with key stakeholders outside R&D such as the commercial Business Units, affiliates. Global Medical, Commercial Quality, etc., supporting post-authorization strategies through thought partnership and linking R&D SMEs and experts, as needed.

How will you contribute:

• Provide expertise clinical research and pharmacovigilance regulations and compliance interpretation, consultation and recommendations to relevant functions in the business units and affiliates.

• Ensure that the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities are considered in their risk-based audit strategy and programs, including supplier audits or internal systems audits. Participate in the audit planning and be a proactive partner in the mitigation of identified risks, ensuring that the risks are communicated and addressed by responsible partners in Global Portfolio Division, R&D and Quality.

• Provide expert input in high to medium and/or potential systemic quality investigations in the business units and affiliates particularly in the clinical research and pharmacovigilance areas including cases of serious breach and scientific misconduct. Liaise with the relevant R&D functions and CPMQ personnel, as needed. Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to Senior Management.

• Supports inspections to ensure that any risks are well-communicated within the GPD and Global Quality organizations.

• Provides input to Global Quality (Global Audit, Compliance and Commercial Quality) on fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research and pharmacovigilance risks that impact marketing authorization holders (MAHs). Analyze and communicate relevant risks within the GPD and Global Quality organizations. Contributes to the relevant quality and compliance governance (e.g., Quality Council) for the business units and affiliates under the GPD.

• Ensures that post-authorization and commercial perspectives are analyzed and understood using CPMQ data trends and insights. Communicates relevant trends and insights to stakeholders in Global Portfolio Division and Global Quality.

• Drives a fit-for-use global Quality framework that elevates the business units and the affiliate capabilities and enables the affiliates to deliver their clinical research and pharmacovigilance related regulated activities (including evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility. Champions and drives proactive and innovative approaches and will engage Quality and business leaders for collabora