Sr Mgr DEA Compliance
Sr Mgr DEA Compliance
Jul 10, 2018
Salt Lake City, Utah, US, 84116
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
The DEA Compliance Sr. Manager
is responsible for the management of DEA Compliance, for specified Teva site(s). 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 medium-sized team of DEA Compliance professionals. Other responsibilities include setting standards for R&D and laboratory activities involving controlled substances, anti-diversion initiatives and working closely with multiple departments within the organization for controlled substance projects to minimize risks associated with diversion.
Actively monitor and assure compliance with 21 CFR 1300, and applicable SOPs .
Assume responsibility in the management, development, and implementation of policies and procedures which minimize the exposure to the adverse effects of pharmaceutical diversion
Effectively manage and ensure appropriate DEA records and reports are accurately completed and filed in accordance with DEA regulations
Lead DEA training programs for direct reports and other departments working with controlled substances as necessary.
Serve as company liaison with the Drug Enforcement Administration Field Office for all DEA related issues at designated sites.
Coordinate and reconcile biennial inventories at ELZ and EDN sites
Conduct investigations for the loss or theft of controlled substances in a timely manner.
Other DEA-related responsibilities as necessary
Education Required: Bachelors Degree in a related field, or equivalent education and experience with controlled substance compliance management in a regulated environment.
Experience Required: 5 years in a the pharmaceutical industry, criminal justice, chemistry, inventory management or related fields
Education Preferred: Bachelors Degree in a related field
Experience Preferred: 7 years in the pharmaceutical industry with emphasis on controlled substance handling and compliance..
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.
JOB SPECIFIC COMPETENCIES:
: Excellent interpersonal, verbal and writing skills required. Ability to prepare documents that are clearly and correctly written. Ability to communicate with individuals at all levels and in different areas of the business within Teva and with mid-level individuals at regulating agencies.
: Possess good analytical and data interpretation skills and have the ability to synthesize complex and diverse information, recognizing trends. Able to identify problems and opportunities and proactively present solutions through detailed analysis of information and data.
Problem Solving / Decision Making
: Must be able to develop resolutions to project-related problems of moderate scope and use resources available to determine appropriate actions for problems presented. Demonstrate judgment to defer mid to high level decisions to appropriate personnel
: Does not hesitate to take the first step or action. Willing to be the originator of ideas, methods or processes. Assumes responsibility for actions and results
Senior Director, DEA Compliance
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
****Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.