Teva Pharmaceuticals USA, Inc.

Manager, DEA Compliance

US-NJ-Elizabeth
Requisition #
17-20329
# Positions
1
Category
Compliance

Overview

 

Position Summary

 

The DEA Compliance Manager is responsible for the management of DEA Compliance, for specified Teva sites or site. Specific responsibilities include implementation of DEA Compliance initiatives, training, serving as liaison with the local DEA Field Office and subject matter expert at the responsible site(s). Provides oversight to and is directly responsible for results of a small team of DEA Compliance professionals. Other responsibilities include anti-diversion initiatives and working closely with multiple departments within the organization for controlled substance project and to minimize risks associated with diversion.

Responsibilities

Essential Duties & Responsibilities

 

Actively monitor and assure compliance with 21 CFR 1300, and applicable SOPs.

 

Assist in the management, development, and implementation of policies and procedures which minimize the exposure to the adverse effects of pharmaceutical diversion.

 

Ensure appropriate DEA records and reports are accurately completed and filed in accordance with DEA regulations.

 

Lead DEA training programs for direct reports and site personnel as necessary.

 

Serve as company liaison with the Drug Enforcement Administration for all DEA related issues at designated sites.

 

Coordinate and reconcile biennial inventories.

 

Conduct investigations for the loss or theft of controlled substances in a timely manner.

 

Other DEA-related responsibilities as necessary.

 

Primary Outcomes

 

Compliance with applicable regulations and SOPs, and established rapport with DEA Field offices

 

Timely completion of reports, audits, investigations.

 

Pro-active anti-diversion programs and DEA policies are current and consistently applied.

Qualifications

Position Requirements

Education Required:

Bachelors Degree in a related field, or equivalent education and experience with controlled substance compliance management in a regulated environment.

 

Education Preferred

Bachelors Degree in a related field

Experience Required:

5 years in a the pharmaceutical industry, criminal justice, chemistry, inventory management or related fields

Experience Preferred:

7 years in the pharmaceutical industry with emphasis on controlled substance handling and compliance..

Company-Related Knowledge:

General knowledge of Teva organization. Knowledge of company procedures related to security, controlled substance handling, and SOPs

Specialized or Technical Knowledge Licenses, Certifications needed:

Working knowledge of the Code of Federal Regulations, particularly title 21; part 1300. Working knowledge of computer software programs (Microsoft Suite applications)

Working knowledge of ORACLE and or SAP preferred.

Functional Knowledge:

Must demonstrate effective written and oral communication skills.

Demonstrates ability to prepare timely, accurate, detailed, and concise reports as requested.

 

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