Controlled Substances Manager

This position is filled by a professional in the pharmaceutical industry with experience interacting with the Drug Enforcement Administration (DEA) and state controlled substance authorities; possesses the knowledge and skills necessary to provide coordination and management in these areas; applies knowledge and experience to manage a program associated with manufacturing controlled substances; ensures that Cephalon – Salt Lake City (SLC) meets the requirements of the DEA; ensure that state licensing requirements are met at SLC site; may represent the company in site inspections by DEA; applies management experience and excellent communications skills within a collaborative environment to assure the site is managed with focused goals and commitment to continuous quality improvement.

•Manage a program that assures Cephalon –SLC is in compliance with DEA regulations.
•Serve as liaison between SLC and DEA for questions and approvals.
•Represent Cephalon – SLC in relevant DEA agency inspections.
•Maintain Cephalon – SLC controlled substance records.
•Maintain power of attorney signature authority for DEA documentation.
•Ensure standard operating procedures pertaining to DEA and state controlled substances programs are in compliance.
•Prepare correspondence and DEA paperwork for the return of controlled substances from US clinical sites.
•Support process security requirements and maintain records for employee screening as required by DEA.
•Prepare quota request for SLC site and interact with DEA office of Drug and Chemical Evaluation to maintain adequate supply of active pharmaceutical ingredients.
•Arrange audits of controlled substance processes, record and inventories.
•Conduct investigations involving controlled substance shortages.
•Prepare, train and oversee year-end physical inventory. Requires successful candidate to be on site full time throughout the last week of each year and the week of September 10th every odd numbered year.
•Prepare routine DEA import and export paperwork.
•Execute, submit and retain DEA paperwork for the transfer of controlled substances between various registrations (internal and external partners).
•Prepare, submit and retain various reports required by DEA (ARCOS, Year End Reports, Procurement quota applications, etc.).
•Control the receipt and vault log-in process of patient returns that contain controlled substances.
•Coordinate processes and record keeping with Material Management personnel involved in vault storage, warehouse shipping and receiving processes.
•Conduct training for employees, including new employee training and annual review training.
•Review batch records and compile variance information quota requests.
•Manage random monthly audits of camera system, looking specifically for unusual behavior or inconsistencies between security measures. Publish report for management review.
•Oversee renewals and maintain current Cephalon, Inc. (Anesta) DEA and state controlled substance registrations.
•Manage the process by which physical destruction of controlled substances are conducted by a contract Reverse Distributor.
•Assist Associate Director, Corporate Controlled Substances as needed.
•Maintain close communication with corporate controlled substance personnel.
•Establish an e-room for all DEA correspondence and related information associated with site activities.
•Provide periodic written reports to corporate controlled substances group.

Requires a bachelor's degree in related field and/or equivalent related experience. Requires five years experience handling federal and state requirements for controlled substances. Requires knowledge of pharmaceutical manufacturing, packaging, labeling, storage, shipping and destruction to ensure compliance with protocols and FDA/DEA regulations.
Must have demonstrated ability to work in teams, solicit cooperation from other managers and departments to meet time schedules. Must be able to frequently interact with functional peer groups and all managerial levels. Interaction normally requires the ability to gain cooperation of others, exchanging technical information concerning specific DEA requirements. Must have excellent communication and organizational skills as well as demonstrated skills as an independent worker.
OR
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=502732-3-553