U.S. Pharmacopeial Convention Jobs

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

The DEA Compliance Manager is responsible for ensuring compliance with applicable DEA and State regulations, working with internal stakeholders to develop and implement streamlined and efficient DEA Compliance related processes and promoting a culture of compliance, safety and security within the organization. The incumbent will develop and support USP’s program for ordering, packaging, and selling of over 130 controlled substances and listed chemicals in compliance with DEA and State regulations. This includes customer orders from over 80 countries around the world, including North America, LATAM, EMEA, India and APAC regions. Additionally, they will handle or oversee all DEA and State registration and reporting requirements, as well as plan and coordinate internal compliance

audits and represent the organization during DEA or State inspections.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with

the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The DEA Compliance Manager will be responsible for the development, implementation, and oversight of USP’s controlled substance portfolio based on current DEA and State Regulations of controlled substances. The incumbent will interact with numerous internal and external customers including DEA and State regulators and Boards of Pharmacy, as well as internal partners across the organization in both the United States and India, as well as our other global locations. This position reports into USP’s Global Compliance & Ethics team.

Specifically, this role will be responsible for:

• Developing, documenting, and maintaining a DEA compliance program that ensures compliance with all applicable regulations, standards, and guidelines, while empowering business groups in effective decision making.

• Implementing and overseeing DEA compliance SOPs, policies and procedures, including training programs and recordkeeping systems.

• Supporting the end-to-end customer ordering and authorization process for domestic and international orders,

• Conducting DEA risk assessments and inspections to identify potential hazards and compliance gaps.

• Developing and implementing corrective actions to address identified compliance issues.

• Managing the DEA audit program to ensure compliance with internal and external regulations and standards.

• Working with cross-functional teams to ensure DEA requirements are seamlessly integrated into business processes, with a constant lean towards efficiency and streamlining.

• Collaborating with regulatory agencies, industry groups, and stakeholders to stay current with DEA regulations and industry best practices.

• Developing and delivering DEA training to employees, contractors, and visitors to promote safety and compliance.

• Serving as a business partner to the organization by providing DEA expertise and guidance to senior management and business units.

• Developing and managing DEA budgets and resources.

Who is USP Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

• Bachelor’s Degree or equivalent experience.

• Minimum 7 years of experience with DEA compliance programs and audits.

Additional Desired Preferences

• Must have extensive knowledge of DEA regulations that apply to controlled substances and Listed Chemicals. Knowledge of State of Maryland and other additional state regulatory requirements is a plus.

• Proficient in DEA reporting software ARCOS.

• Must have the ability to plan and manage multiple tasks while working with individuals across the organization at all levels.

• Ability and desire to work well with diverse internal and external stakeholders in a cooperative manner.

• Must have superior oral and written communication skills.

• Must possess strong attention to detail.

• Must have the ability to take initiative and work independently where appropriate.

• Must be proficient in Word, Excel, PowerPoint, and Oracle.

Supervisory Responsibilities

None.

Benefits

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

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

Note: 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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Legal

Job Type Full-Time