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||This position reports to the Director, Commercial Compliance and is responsible for assisting in the preparation and filing of all required federal and state reports and certifications. The Compliance Analyst will manage key aspects of the Company’s aggregate spend reporting program, including the tracking, monitoring, managing and reporting of the Company’s aggregate spend with healthcare professionals (HCPs) and healthcare organizations (HCOs), as well as playing an active role in the development of associated business processes, systems and tools.
||The Compliance Analyst will:
• Lead the preparation and submission of required federal, state and other reports, certifications, and payment of reporting fees. In addition, will draft responses to any inquiries from government entities, regulatory authorities, industry groups, HCPs and other third parties relating to the reports or their underlying data.
• Partner with the Director, Commercial Compliance on the implementation of the Federal Sunshine Act regulations, including system modifications, process/procedure modifications, and the creation of an HCP dispute resolution process.
• Manage the analysis and compilation of data necessary to satisfy the Company's federal, state and other reporting requirements, including ensuring system templates are accurately set-up to capture data based on the Company’s interpretation of the laws/regulations, identifying and resolving potential data gaps and data integrity issues, and analyzing HCP payment records for compliance with laws, regulations, and company policy.
• Research and stay current with applicable federal and state legislative and regulatory reporting requirements (i.e., analyze federal and state communications, attends industry conferences, consults with industry counterparts and experts and proactively recommends best data collection and reporting practices).
• Serve as main point of contact within the Company for aggregate spend reporting with responsibility for drafting and implementing policies, procedures, and training materials.
• Work closely with colleagues across the organization to ensure accurate data collection and reporting, including working with Finance, Sales, Marketing, Research and Development, Medical Affairs, IT and other departments.
• Work closely with Legal and Compliance Departments to interpret laws and regulations and determine how they apply to the Company’s business operations.
• Independently manage tasks and projects related to aggregate spend.
• Other duties as assigned
EDUCATION and EXPERIENCE:
• B.A. or B.S. degree required, with a minimum 3 years of experience in a pharmaceutical, medical device or biotechnology company, healthcare company and/or hospital. Preference will be given to individuals with substantive experience in healthcare compliance or accounting functions.
• Demonstrated knowledge and understanding of healthcare compliance issues and the applicable legal and regulatory framework governing aggregate spend, federal and state reporting.
• Demonstrated project management skills, including the ability to effectively plan, prioritize, and execute projects in a timely manner and the ability to work on multiple projects simultaneously with little or no supervision under tight deadlines.
• Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues, anticipate needs and develop practical, meaningful solutions.
• Ability to collaborate with multiple functional units and interact with colleagues with appropriate respect and sensitivity.
• Position requires attention to detail and excellent document management skills.
• Excellent verbal and written communication skills.
KEY DEPOMED COMPETENCIES INCLUDE:
• Decisions & Judgment
• Ownership & Initiative
• Adaptability & Change Readiness
• Teamwork & Collaboration
PHYSICAL / MENTAL DEMANDS:
• Sitting 80%; walking / standing 20%
• Physically transporting items weighing less than 15 pounds from one location to another
• Able to see and read PC screens; detect color coding, read fine print, and/or normal type size print
• Ability to communicate clearly and professionally both verbally and in writing
• Ability to manage highly confidential information
• Ability to conduct oneself professionally at all times
• Ability to understand complex problems and to collaborate and explore alternative solutions
• Ability to compose reports and procedures.
• Ability to compute, analyze, and interpret numerical data for reporting purposes
• Ability to organize and prioritize own work schedule
• Ability to count accurately and check results for accuracy
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required.
||Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. The company was founded in 1995 and has established itself by developing and incorporating promising technology into differentiated therapeutic products, taking those products through clinical approval, and building a strong market presence. The company currently markets four FDA-approved products, Gralise® (gabapentin) tablets for the management of Postherpetic Neuralgia (PHN), Cambia® (diclofenac potassium for oral solution) for acute treatment of migraine attacks with or without aura in adults 18 years of age or older, Zipsor® (diclofenac potassium) liquid filled capsules for relief of mild to moderate acute pain, and Lazanda® (fentanyl) nasal spray CII for the management of breakthrough pain in cancer patients. See Important Safety Information for Gralise, Cambia, Zipsor, and Lazanda.
We are an AA/EEO/Veterans/Disabled employer