The qualified individual will be responsible for managing assigned tasks as part of the DEA Compliance Group as they relate to the Drug Enforcement Administration (DEA), the New Jersey Department of Health and the State of New Jersey Controlled Dangerous Substances (CDS), as well as ensure compliance with all federal and state regulations and requirements as they apply to controlled substances and listed chemicals.
Responsibilities :
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.
Qualifications :
- Previous pharmaceutical experience (generic experience preferred, but Brand Pharma is OK).
- DEA experience in Pharma is highly desired - OR - educational equivalent.
- Knowledge of 21 CFR Part 1300-End.
- GMP Knowledge is a must.
- Computer proficiency; MS Office applications.
- Excellent record keeping and organization skills.
- Ability to take initiative as issues arise.
- Excellent verbal and written communication skills.
- Solid analytical and problem-solving skills, critical-thinking and attention to detail.
- Ability to meet accelerated timelines, and manage priorities.
- This role will provide assistance to the DEA Compliance Manager, and will need to perform other duties as assigned.
- This role will be required to have Power-of-Attorney for DEA 222 forms for the purchase of schedule I and II controlled substances
- Good PC skills.
- Excellent record keeping and organization skills.
- Excellent verbal and written communication skills.
- Solid analytical and problem-solving skills, critical-thinking and attention to detail.
- Ability to meet accelerated timelines, and manage priorities.
Education & Experience :
- Bachelor's Degree preferred or equivalent experience.
- DEA experience in Pharma is highly desired - OR - educational equivalent.
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