Sr. Specialist, Dea Compliance-Onsite-5690

Job Title:Sr. Specialist, DEA Compliance
Location: Columbus, OH
Job Type: Full time
Req ID: 5690
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Specialist, DEA Compliance to join our team. In this role, you will be responsible for ensuring compliance to DEA regulatory requirements and confirming DEA systems, processes, and procedures are in place and properly managed to prevent non-compliance and mitigate risk. Performing suspicious order monitoring (SOM) and customer due diligence review activities. Responsible for DEA record keeping, annual DEA registration renewal, submission of DEA procurement quota, periodic controlled substance inventory, and submission of theft/loss reports. This role must engage with all other functional areas and must network and leverage relationships locally, regionally, and globally as appropriate. This role delivers results through execution of activities at all sites and interacts with individuals within the organization who have different personalities, styles, expectations, and motivations.
Decision making can significantly impact compliance, including cost of non-conformance, potential regulatory citations, and fines. This role has the authority to decline sales orders and to stop processes that are not in compliance with internal or regulatory requirements. Decisions made can also set a precedent; therefore, critical assessment of all possible solutions is required to prevent unnecessary actions. You will work closely with various individuals throughout the organization. This role must communicate effectively to present succinct information and respond to inquiries; Interacts with individuals outside the organization, including regulatory inspectors, who have different personalities, styles, expectations, and motivations. This role is encouraged to network and leverage relationships with professional organizations from outside the organization.
Key Responsibilities:

• Executes Suspicious Order Monitoring (SOM) program activities including:
  • Analyzing controlled substance orders and SOM data for trends.
  • Investigating orders of interest and ensuring timely completion.
  • Making order release or cancellation recommendations based on investigation information.
  • Maintaining documentation for orders of interest.
  • Reporting suspicious orders to the DEA and applicable State Boards of Pharmacy.
  • Evaluating potential for diversion trends and making recommendations.
• Executes customer due diligence activities including:
  • Conducting controlled substance customer account set up due diligence reviews.
  • Assessing new and existing controlled substance customer due diligence SOM questionnaires.
  • Analyzing charge back reports or other data for trends.
  • Coordinating on-site visits of new and existing controlled substance customers.
• Supports cross-functional meetings to discuss periodic analyses and making recommendations to minimize risks associated with diversion potential.
• Executes and ensures controlled substance documentation complies with federal /state regulatory requirements and is maintained in an inspection-ready state.
• Performs internal DEA audits to ensure compliance with established procedures and regulatory requirements. Obtains mutual agreements of CAPAs and facilitates to completion.
• Provides support with external DEA audits.
• Acts as subject matter expert for DEA inquiries, SOM/customer due diligence-focused systems / projects and provides training to new members of the organization.
• Maintains DEA registrations to ensure timely renewal.
• Maintains Power of Attorney documentation.
• Completes periodic controlled substance inventory.
• Prepares and submits theft/loss reports and verification requests in the defined timeframe.
• Prepares and submits DEA Quota
• Investigates DEA related matters.
• Leads the DEA Center of Excellence.
• Carries out duties in compliance with all state and federal regulations/guidelines and complies with all company policies, standards and procedures.

Leads and/or participates in process improvement activities, including assessing current processes, providing improvement input and working with partners to implement changes.

• Monitors, interprets, and implements DEA regulations including SOM and due diligence.
• Ensures DEA policies, procedures, and templates are in place to meet regulatory and internal requirements.

Facilitates cross-functional review of regulations or corporate policies.
Skills

• Physical Demands/Surroundings
  • Must pass a drug screen prior to starting employment.
  • Flexibility required meeting the different business units' schedules and needs.
  • Work pace may vary from day to day.
• Visual Demands
  • Vision clarity with or without correction to read handwritten data, computer-generated documents, and judge distance.
  • Perceiving sound by ear is necessary for conversational purposes and to be aware of machine operations, and/or office environment.
• Temperaments/Mental Requirements
  • High degree of mental effort required to interpret regulations, analyze and interpret data, make decisions, and provide direction to the organization.
  • Strong attention to detail and ability to problem solve
  • Strong written and verbal communication skills are necessary to interact with customers, co-workers and to complete documentation.
  • Ability to work independently, in a team atmosphere, and with employees at all levels.
  • Alertness and awareness of the general work area is necessary at all times.
  • Long and short-term memory is utilized for procedures and processes.
• Level of Proficiency
  • Complexity of job is best described as high due to the difficulty of interpretation of numerous guidelines and regulations which are then incorporated into the philosophies of the site.
  • Converse in Standard English at high school graduate level, and comprehend written communication for basic instructions, safety rules, and procedures at high school graduate level.
  • Knowledge and execution of and compliance at all times with departmental safety, quality, operational procedures, regulatory, and company policies and procedures are required.
  • Demonstrated computer skills.

Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• • Minimum Education: Bachelor's degree required, preferably in a Quality Discipline, Business Administration, Legal, or a discipline closely related to Quality Systems & Compliance.
  • Minimum Experience: Minimum of five (5) years of experience working in a pharmaceutical/regulated (DEA/GMP) environment.
  • Minimum of two (2) years in a Quality/Compliance role.
  • Demonstrated knowledge of DEA regulatory requirements and records required.
  • Demonstrated ability to effectively interpret regulations.
  • Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint, Outlook).
  • Demonstrated critical thinking to identify underlying principles, reasons, or facts of information by breaking down information or data in separate parts and making decisions based on analysis. Uses good judgment. Proven ability to shift thought processes quickly and accurately from one project to another.

Preferred Qualifications:

• • Preferred Experience: Experience in conducting SOM activities and associated investigations.
  • Demonstrated data analytical skills to detect trends and patterns.
  • Experience in pharmaceutical manufacturing environment.
  • Experience and inspection interaction with State and Federal regulatory officials (i.e. DEA, FDA, or Board of Pharmacy) required.
  • Experience managing multiple concurrent priorities and adapting to changing priorities to meet established timelines.
• Knowledge of application software such as SAP, Trackwise, QSDB, and ARQ (document management system) preferred.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location: