DEA Coordinator at Indivior in Raleigh, North Carolina

Job Description:

TITLE:
DEA Coordinator

Title: DEA Coordinator

Reports To: EH&S Manager

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

The DEA Coordinator role is vital to ensure that Indivior Manufacturing remains in compliance with DEA regulations in the accountability of the movement of controlled substances. Reporting to the EH&S Manager, the DEA Coordinator will be expected to provide DEA regulatory guidance to internal stakeholders, submit DEA Export Applications, issue DEA222 forms, maintain DEA registrations, and manage controlled substance destruction.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

• 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.


• Apply for DEA Federal and State Registrations and Maintain State License Display Board


• Maintain Registration and License display board in controlled substances office.


• 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.

• 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.

In addition to the minimum qualifications, the employee will demonstrate:

• 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.

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes

• 3 weeks' vacation plus floating holidays and sick leave


• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay


• U.S. Employee Stock Purchase Plan- 15% Discount


• Comprehensive Medical, Dental, Vision, Life and Disability coverage


• Health and Dependent Care Flex Spending options


• Adoption assistance


• Tuition reimbursement


• Leverage Concierge/personal assistance services


• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage


• Gym, fitness facility and cell phone discounts


• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled