Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Specialist, Controlled Substances Compliance - Analyst position reviews direct customer orders flagged for review and participates in a multi-level process to evaluate and recommend disposition of the order in accordance with company policy; review customer questionnaires for completeness and accuracy and conducts appropriate follow-up with customers as necessary; audits internal processes to ensure compliance with company policies and procedures; facilitates activities of the Suspicious Order Monitoring Team (SOMT).
Job Description
Essential Functions
Direct Customer Orders Reviewed & Dispositioned
- Conducts first-level review of direct customer orders flagged by company algorithms and recommends whether they may be released per SOPs.
- Coordinates with the Commercial business unit representatives (National Account Directors and Product Managers) to gather the information (forecasts, etc) necessary to aid decision making on flagged orders.
- Review customer forecasts for focus products
- Contacts direct customers for due diligence information when needed.
- Creates and maintains the documentation necessary to satisfy the DEA’s requirement for the reporting of suspicious orders per record retention policy.
- Reviews Direct Order Dashboard and other company data to detect patterns that may be related to a specific customer account.
- Track metrics for reporting to the Suspicious Order Monitoring Team.
Know Your Customer (KYC) Program
- Reviews direct customer KYC questionnaires for completeness and thoroughness.
- Schedules and participates in customer reviews with CS Compliance staff.
- Maintains KYC documents for all direct customers in accordance with SOPs.
- Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
Support Suspicious Order Monitoring Team
- Assist with managing a program of media/internet source reviews to identify downstream customers to be further investigated.
- Facilitate SOMT Meetings – Preparing meeting minutes.
- Prepare and send notices to DEA of pharmacy restrictions
Minimum Requirements
Education
- Bachelor’s degree or equivalent relevant experience, including statistical analysis preferred.
Experience
- Prior experience in Controlled Substance Compliance in the private sector or as a government investigator/regulator preferred.
Preferred Skills/Competencies
- Experience in data analytics including Excel pivot tables and charts, graphs.
- Working knowledge of Word and PowerPoint.
- Experience auditing internal processes to ensure compliance with regulations and company policies and procedures.
- Self-motivated; able to work with various departments internally and contacts outside of the organization.
- Must take initiative and act without direction when appropriate.
- Knowledge of regulatory reporting systems.
- Previous experience with DEA recordkeeping.
- Excellent oral and written communication skills.
- Detail oriented.
- Strong organizational skills.
Organizational Relationship/Scope
Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
Escalation Process Adherence: Understands the scope of his/her decision-making authority; sorts through the facts and personal knowledge level to determine if an issue can be managed effectively or if it needs to be elevated to someone with additional knowledge that would impact the outcome; does not much let time lapse prior to making the decision to let others know; clearly and concisely explains the issue to senior leadership; ensures handoff to the next level has occurred.
Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and sets the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more dome in less time than others; can attend to a broader range of activities.
Working Conditions
Physical/visual activities or demands that are commonly associated with the performance of the functions of this job
- Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
- Handling of pharmaceutical product (packaged/bulk).
- Finger dexterity required to operate computer keyboard.
- Hearing at a level to enable one to hear normal conversation.
- Visual requirements of having the ability to read the computer screen, documents.
- Must wear safety glasses and other protective items as required.
- Sitting 75% of the day; standing or walking 25%.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
