US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health.
Summary of the Position:
Functions as a compliance specialist responsible for reviewing and finalizing vendor, 3 rd party and public health related due diligence. Provide support to global compliance team on compliance and ethics related matters and other support areas identified, as necessary.
Roles And Responsibilities
Global Compliance & Ethics Support (75%)
- Interact with GCE, stakeholders in the organization to support the due diligence process, including providing answers to questions, document collection and review.
- Prepare, finalize and put up for review due diligence reports for prospective Business Partners.
- Gather information from Stakeholders on prospective Business Partners and facilitate the due diligence review.
- Recommend mitigation activities for red flags identified during the due diligence process.
- Finalize the due diligence recommendation or otherwise escalate and provide recommendations to Global Compliance team.
- Assist with USPs annual Conflicts of Interest Disclosures process.
- Work with the Senior Compliance Manager to draft and review SOPs, job aids and other documentation pertaining to the Compliance & Ethics program.
- Monitor and respond to incoming emails and queries. Coordinate with key Stakeholders to ensure post-approval follow up or monitoring steps;
- Archive due diligence review documents and approval forms;
- Any other compliance support identified from time to time by VP Quality & Compliance and Director – Legal & Compliance;
Other areas of contribution; (25%)
- Assist Director Legal & Compliance with site related activities pertaining to maintaining the e-Compliance system, mapping, reviewing and monitoring the system, act as a system administrator;
- Manage, review, report and help stakeholders with compliances listed in the system;
- Keep abreast on local and central regulations impacting USP operations and ensure compliance with these regulations are mapped and included in the e-Compliance system ;
- Assist site legal team with support pertaining to site compliance, legal, contractual or other operational needs;
- Assist Director – Legal & Compliance with preparing, reviewing and maintaining Corporate Secretarial records such as board minutes, general meeting documents, upkeep and maintain legal records and registers
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