JobMesh

Sr. Manager, Wholesale Regulatory & Compliance

BirdiRx · Plymouth, Michigan, US

Essential Duties/Responsibilities: · Act as the main point of contact and subject matter expert for the organization’s pharmacy and wholesale distribution DS...

Job description

Essential Duties/Responsibilities: · Act as the main point of contact and subject matter expert for the organization’s pharmacy and wholesale distribution DSCSA (Drug Supply Chain Security Act) programs. · Monitor and manage day-to-day activities related to serialization/ ERP/ EDI transactions, and compliance and assist in resolving issues in the supply chain to ensure business continuity, collaborate with internal/ external partners (i.e. 3PLs, wholesaler/distributors, manufacturers, pharmacies, outside vendors, internal company stakeholders, etc.) on resolution of issues and escalate issues to the appropriate functions when needed. · Monitor data quality and ensure compliance with DSCSA regulations. · Conduct regular audits to ensure the accuracy and completeness of regulatory compliance records. · Conduct regulatory intelligence to gather knowledge of relevant guidelines, regulations and legislation, including proposed and final rules to all federal, state and local regulations/laws impacting the pharmacy and wholesale distribution lines of business to ensure a continuous state of compliance, reporting key findings to managers on a regular basis. · Liaise with state boards of ph...