Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions

Darum lohnt es sich

Title Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions Location US Remote About the role As an Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions, you will provide oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates.

You will drive 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.

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

How will you contribute Provide expertise in 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 in their risk‑based audit strategy and programs, including supplier audits and internal systems audits.

Participate in audit planning and be a proactive partner in the mitigation of identified risks, ensuring that the risks are communicated an