DEA Compliance Specialist

Summary

Assist in the day-to-day activities of the DEA Compliance program as it relates to the Drug Enforcement Agency (DEA), Missouri Board of Pharmacy and the Missouri Bureau of Narcotics and Dangerous Drugs, as well as ensure compliance with all federal and state regulations and requirements as they apply to controlled substances.    

Essential Duties and Responsibilities

• Assist in the development and revision of procedures for the control of scheduled drugs to ensure correct documentation, traceability, and accountability.
• Assist in the preparation and submission of periodic reports for the DEA (ARCOS, YERS, etc.).
• Assist in the preparation and submission of all Quota procurement requests for Commercial and R&D activities, including assistance in preparation of supporting data, as required.
• Assist in investigations of inventory discrepancies and in-transit losses and report findings to the DEA as necessary.
• Work with DEA Compliance management and Zydus U.S. Marketing/Sales to support the suspicious order monitoring program. 
• Provide support to DEA Compliance management for identifying and achieving key company, operations, and departmental strategies, tactics, and objectives relating to DEA compliance.
• Perform DEA Compliance-related audits of various partners, including distribution, sales customers, etc., as assigned.
• Maintain an understanding of the overall business needs and objectives, including sales, marketing, manufacturing, etc.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledge of and ability to apply cGMP regulations and DEA regulations pertaining to controlled substances.
• Demonstrated interpersonal skills to develop and maintain strong working relationships with diverse individuals and work groups in a multi-disciplinary environment.
• Strong oral and written communication skills, with ability to be clear and succinct in a variety of communication settings and styles; to include reports, presentations and technical documents.
• Advanced organizational skills to complete multiple activities and projects on time and within defined scope/requirements.
• Demonstrated expertise utilizing contemporary tools to meet current and advancing cGMP requirements.

EDUCATION/EXPERIENCE

• Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related field preferred; or equivalent combination of education and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
• A minimum of two years' experience in the pharmaceutical industry with at least two years in DEA Compliance, or relevant experience in a related field.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

Stand, walk, sit, reach, talk, and hear.

2.       Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1.       Normal office conditions.

Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.

Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for DEA Compliance Specialist Jobs at Nesher Pharmaceuticals (USA) LLC