Job Description
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.