Trade Compliance Associate Manager

Regeneron

Sleepy Hollow, NY, USA

Full time

Sep 7

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

In this role a typical day may include:

  • Maintain department Audit activity tracking – schedule of audits for IT, Global Patient Safety, cGMP, Internal Audit, etc.; oversees responses and timing of corrective action deployment; engagement with other departments and vendors as necessary to address audit findings.
  • Responsible for enforcement and monitoring of DDA requirements from the National Association of the Board of Pharmacy for RHS activities

This role may be for you if you:

  • Create and ensure completion of checklist of annual Trade compliance requirements
  • Support Good Distribution Practices (GDP) and contract requirements at distribution partners, including oversight at facilities in our distribution networks.
  • Document Trade Department policies and procedures – includes Doc Compliance (internal SOP and training system for Regeneron) oversight of all applicable SOPs and change control management; training for policy changes coordinated through Learning systems and/or Commercial Training.
  • Establish paper and electronic system for filing required records and standardize record retention processes in accordance with Regeneron guidelines. Including but not limited to: Process document updates; amendment and notification tracking; Operations contract renewal monitoring; document and track completion of required activities, i.e. annual reporting to Regeneron; recall effectiveness checks; Trade policies & procedures, desk work instructions and best practices, etc.
  • Monitoring global brand security program including weekly sales exception reports to address potential leakage within the supply chain
  • Collaborate with IOPS Warehouse & Logistics, 3PLsand Trade Relations Managers (Distributors/SPs) to oversee action items related to non-conformances, resulting resolutions for non-conformances and program changes.
  • Tracking of adherence to state, national, federal trade and distribution requirements and industry standards, i.e. Healthcare Distribution Association (HDA) criteria
  • Coordinate and monitor required internal Trade team training (i.e. VAWD and DSCSA standards, others as identified).
  • Returns System auditing; Regularly review returns cases to ensure proper documentation and business rules are applied; monitor for policy abuse; work in conjunction with Commercial IT and Trade Operations Specialist to verify Returns system data is accurate and up to date as well as support ongoing system life-cycle management to support changing business processes
  • Manage user system access requests for Trade owned systems and/or programs (ICS Portal, Salesforce for Returns program, SharePoint, Microsoft Teams, OneNote, etc.)
  • Maintain documentation around one-off issues raised (i.e., Temp Alerts, frozen drug deliveries, re-routing of product within the supply chain due to disaster preparedness activities) and help create corrective action plans for observations identified with stakeholders
  • Ongoing reporting to Trade Management and other stakeholders as identified of departmental activities including at minimum: training, policy development, service level metrics, audit findings or services issues, field inquires/needs/trends, etc.
  • Develop and implement Standard Operating Procedures
  • Ensure compliance with government regulations and company processes
  • Take on other responsibilities, as needed by the business over time

To be considered for this position, you must have 3-5 years of experience in a related compliance or operations role. be detail-orientated with strong problem-solving interpersonal skills, both written and verbal. Have the ability to deliver on timelines while leading multiple projects effectively. The ability to create and document process and procedures. Be proactive, self-motivated, and able to work well in multifaceted environment. Develop, enhance, and implement Compliance policies and procedures for Trade Team that reflective of applicable laws, regulations, government guidance, industry codes, and Regeneron policies. Prior project management experience helpful not required.

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