U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Compliance Manager in Hyderabad, India

Description

Roles and Responsibilities

1.Global Compliance & Ethics Support (75%)

  • Interact with GCE, stakeholders across the organization to manage enhanced due diligence requirements associated with the PQM+ (Promoting Quality Medicine) program and other government funded programs.

  • Prepare, finalize and put up for review due diligence reports for prospective Business Partners.

  • 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.

  • Support USPs annual Conflicts of Interest Disclosures process by collecting, reviewing and triaging COI disclosures; escalating as needed.

  • Work with the Director – Global Compliance & Ethics to draft and review standards, SOPs, job aids and other documentation pertaining to the Compliance & Ethics program.

  • Monitor, respond and track incoming emails and queries. Coordinate with key Stakeholders to ensure post-approval follow up or monitoring steps;

  • Ensure adequate case entry and close-out procedures maintained in the case tracking system.

  • Act as an advocate and champion of the compliance and ethics program among managers and staff through training, day-to-day advice, and guidance on compliance and ethics matters.

  • Assist the Director – Global Compliance & Ethics to continue to embed a culture of compliance and ethics including training on and reinforcing employee and business partner awareness regarding the risks associated with illegal, unethical, or improper conduct.

  • Coordinate training and other activities with Ethics Liaisons in each office.

  • Any other compliance support identified from time to time by management;

2.Local Compliance and other areas of contribution; (25%)

  • Assist Sr. Director - Operations 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.

  • Regulatory and risk landscaping - 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; Lead and represent the compliance team on risk assessment projects, litigation risks, insurance risks and other compliance risk assessment and mitigation activities by engaging with stakeholders and preparing risk assessment and mitigation plans.

  • Act as the compliance representative for all USP policy related aspects such as employee handbook, build and draft policies, work with HR and other stakeholders in reviewing and assessing policies to ensure they are consistent with global and local law.

Basic Qualifications

  • A recognized law degree or master’s degree in Law; or a Graduate in Commerce / Business Studies with recognized compliance certification; Minimum of 5-8 years of experience in the field of professional and/or corporate communications.

Supervisory Responsibilities

None

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Note: As a condition of employment with United States Pharmacopeia- India Private Limited’s (USP), duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a a reasonable accommodation is approved.

Job Category Legal

Job Type Full-Time

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