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The Senior Manager, Wholesale Regulatory & Compliance will be responsible for the research, review, interpretation, and assisting business unit owners with the implementation of emerging federal, state and local legislation, and regulations that impact the organization's pharmacy and wholesale distribution operations. Responsible for the collection and management of regulatory compliance data to ensure it is accurate and up to date in a regularly maintained database. Ensuring the legal department's regulatory standards and procedures are properly implemented and regulatory compliance is maintained.
Essential Duties/Responsibilities:
• Act as the main point of contact and subject matter expert for the organization's pharmacy and wholesale distribution DSCSA (Drug Supply Chain Security Act) programs.
• Monitor and manage day-to-day activities related to serialization/ ERP/ EDI transactions, and compliance and assist in resolving issues in the supply chain to ensure business continuity, collaborate with internal/ external partners (i.e. 3PLs, wholesaler/distributors, manufacturers, pharmacies, outside vendors, internal company stakeholders, etc.) on resolution of issues and escalate issues to the appropriate functions when needed.
• Monitor data quality and ensure compliance with DSCSA regulations.
• Conduct regular audits to ensure the accuracy and completeness of regulatory compliance records.
• Conduct regulatory intelligence to gather knowledge of relevant guidelines, regulations and legislation, including proposed and final rules to all federal, state and local regulations/laws impacting the pharmacy and wholesale distribution lines of business to ensure a continuous state of compliance, reporting key findings to managers on a regular basis.
• Liaise with state boards of pharmacy, regulatory agencies (CMS, FDA, DEA, NABP, etc.), and other relevant authorities to address any questions or issues related to regulatory actions.
• Conducts training activities, as needed, to ensure Birdi workforce are aware of regulatory/compliance related requirements and related business obligations.
• Collaborate with legal and compliance teams to address any regulatory issues.
• Identify opportunities to streamline and improve accuracy in managing regulatory matters.
• Communicate and provide information, guidance and training to other teams on regulatory requirements, rules and regulations to ensure information is interpreted and implemented correctly.
• Ensure internal regulatory guidance documents, policies, and procedures align with all applicable mandated pharmacy and wholesale distribution requirements, ensuring corresponding departments understand how to comply for continued operational excellence.
• Maintain orderly and accurate records, files and documentation.
• Other duties and/or special projects as assigned.
Required Skills/Abilities:
• Excellent communication, interpersonal, and organizational skills with a demonstrated ability to manage multiple projects, prioritizing tasks and meeting demands in a fast-paced environment.
• Maintain acute problem-solving ability and analytical skills together with thorough knowledge of the regulatory process, rules and regulations, and industry trends.
• Ability to manage complex documentation and reporting requirements.
• Strong knowledge of pharmacy processes and regulations within a controlled multistate space.
• Ability to understand and carry out instructions with limited direction.
• Possess a detail-oriented perspective.
• Ability to maintain confidentiality of information and data in accordance with policies.
• Ability to work extended hours, weekends, and holidays in alignment with departmental and industry demands.
Education/Experience:
• Bachelor's degree in business administration, or a related field is required.
• Minimum of 5-8 years of experience supporting legal or regulatory compliance efforts preferred.
• Pharmacy Technician Certification preferred.
Preferred Skill/Abilities:
• Strong ability to interact effectively with regulatory agencies, healthcare professionals, and internal teams.
• Experience with Serialization Systems: Tracelink, Rfxcel, LSPEDIA, etc.
• Strong knowledge of GS1 Serialization Data Standards.
• Knowledge of Good Manufacturing Practice (GMP) & Good Documentation Practice (GDP).
• Proficient to expert level of knowledge of variety of computer software applications in word processing, spreadsheets, database, and presentation software (Word, Excel, SharePoint, Smartsheet, PowerPoint).
• Previous work experience at a pharmacy or wholesale distributor.
Work Environment/Physical Requirements:
• Home-based office environment, with minimal exposure to excessive noise or adverse environmental issues, and occasional local and/or overnight travel, including exposure to heat, cold, and inclement weather conditions.
• Ability to sit and stand for prolonged periods of time.
Equal Opportunity Employer
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