The Manager, DEA Compliance will be responsible for leading the development, implementation, and organization of the companies Controlled Substance Program based on current DEA and State Regulations of controlled substances. Qualified candidates will have a diverse set of responsibilities. Some of these responsibilities include:
ESSENTIAL DUTIES AND RESPONSIBILITIES: • Direct responsibility to implement, manage, and maintain Corporate DEA Compliance Program and collaborate with leadership teams within Akorn to determine the overall DEA Compliance Strategy • Maintain DEA related SOPs • Oversee controlled substances activities at all Manufacturing, Research, Analytical Labs & Distribution Facilities • Responsibility for maintaining Akorn’s evolving Suspicious Order Monitoring Program and strategy while maintaining regulatory compliance and lead enhancement development • Serve as Akorn liaison to the DEA • Investigate allegations of non-compliance • Investigate non-conformance reports associated with controlled substances • Ensure Compliance with DEA Import/Export Regulations • Serve as Principle Investigator on potential diversion and security breaches and represent “security” in the design of all construction and renovation initiatives within Akorn • Ensure proper security controls are in place for shipping and receiving controlled drugs • Represent logistics as SME for Secure Controlled Substance related shipments both TL & LTL Carrier Requirements • ARCOS reporting • Coordination of controlled drugs destructions in accordance with DEA regulations • Manage biennial and yearend inventories • Review cGMP documentation related to controlled substances • Monitor the use of DEA222 order forms for compliance with DEA requirements • Oversee the applications (DEA250) for procurement quota • Manage controlled substance inventory and monitor all associated activities • Monitor all licensing requirements regarding the handling of controlled material
Qualifications EDUCATION AND EXPERIENCE: * A minimum of a bachelor's degree * Minimum of 10 years of pharmaceutical experience and working knowledge of DEA Regulations * Strong computer skills, ideally with experience using Windows-based PC programs * Strong familiarity with FDA, DEA and cGMPs * Ability to coordinate multiple group efforts within the company to achieve objectives * Excellent written and verbal communication skills * Excellent organizational and problem solving skills * Ability to identify processes needing improvement, and to recommend improvements
JOB PREREQUISITES: * High ethical standards, integrity and strength of character in his/her personal and professional dealings and a willingness to act on and be accountable for his/her decisions. * Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. * Develop and communicate effective business cases for change and new initiatives that transcend current practices. * Encourage others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitate the implementation and acceptance of change within the workplace. * Demonstrates accuracy and thoroughness; applies feedback to improve performance; monitors own work to ensure quality. * Initiative: Asks for and offers help when needed. * Professionalism: Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions. * Meets productivity standards; completes work in timely manner. * Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully.
PHYSICAL DEMANDS AND WORK ENVIRONMENT: While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise). Mental Requirements include: * Ability to hear accurately the spoken word with moderate office noise or plant noise * Ability to apply deductive reasoning and understand complicated issues * Ability to receive instructions and follow work rules and company policies * Ability to follow safety and security practices * Ability to meet deadlines and effectively deal with office stress * Ability to accurately communicate ideas, facts and technical information * Maintain confidentiality of certain information
Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
EEO Statement Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.