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.