U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Compliance Specialist-Contract in Hyderabad, India

Description

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;

Education and Experience:

A recognized Degree or Master’s Degree in Law; Or a Graduate in Commerce with recognized compliance certification;

Experience:

Fresher or any candidate interested in the role with at least 3-5 years experience

Frequent Contacts:

Vice President, Global Quality & Compliance, Rockville

Senior Compliance Manager, Global Quality Assurance

Director – Legal & Compliance, India

Legal Counsel, India

Internal stakeholders

Supervisory Requirements:

Direct – None.

Qualifications

Education

Required

  • Bachelors or better in Law

Job Category Legal

Job Type Full-Time

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