The Licensing & Compliance Specialist I is responsible for maintaining U.S. state licenses for AbbVie and AbbVie entities to manufacture, sell and distribute non-controlled and controlled prescription and non-prescription pharmaceutical products and devices for multiple manufacturing, distribution and virtual locations. The Licensing & Compliance Specialist I also creates, edits, maintains, distributes and processes quality and procedural documents for U.S. Distribution Operations and trains personnel on how to use the document system. This role is responsible for maintaining the document center to meet current quality and regulatory requirements. This role also will have project management responsibilities related to state licensing, document center and distribution related projects, including supporting distribution operations and 3rd Party Logistics Providers. This role will also provide support for internal and external audits of U.S. Distribution Operations.
- Responsible for an increasingly complex and challenging state licensing compliance environment for federal and state level drug manufacturers, wholesalers, distributors and third-party logistics providers, including controlled substances.
- Maintain current and obtain new state licenses for AbbVie and AbbVie entity domestic U.S. manufacturing and distribution locations. This role will work with AbbVie Legal and outside legal counsel analyzing state licensure requirements. This role also must maintain a comfortable working relationship with personnel, including inspectors, compliance officers and license processors at the state Boards of Pharmacy.
- Project management responsibilities related to state licensing, document center and distribution related projects.
- Train, support and assist team members in processing quality policies and procedures in the document center.
- Publish and distribute DC Bulletins that document temporary procedures or data for informational purposes.
- This role must be able to work effectively as an individual contributor, as well as a member of the team, and be able to take ownership of their responsibilities with minimal direction.
- Maintain electronic system to track registrations and license pertinent data, including submission dates, expiration dates, state licensing contact information, feedback/follow up from licensing agencies.
- Responsible for awareness and action for changes and updates to federal and state license regulations, statues, requirements and laws as it pertains to state licensing to ensure company compliance.
- This role will interact with both internal and external auditors and with internal company senior leadership.
- BA/BS or equivalent experience.
- Must possess effective written, oral and interpersonal communication skills with both internal and external customers, including government agencies.
- Must be able to problem solve, manage their time effectively and be able to balance many tasks throughout the course of the day.
- Excellent organizational skills and consistent follow up with state licensing agencies are key to this role.
- Knowledge and understanding of the Pharmaceutical Supply Chain in relationship to federal and state licensing agencies, such as Boards of Pharmacy, state professional licensing agencies and NABP (DDA Accreditation).
- Knowledge and understanding of state, federal and DSCSA statues, regulations, requirements and guidelines for compliance requirements for reporting and changes that impact currently held licenses and new required licenses.
- Extensive working knowledge of Microsoft Word and Excel, SharePoint and shared databases. SAP/EWM/WM knowledge is a plus. Attache/AttachePro knowledge is a plus.
- Position may be domiciled in either North Chicago, IL or Madison, NJ. 25% travel is required.
Manager, Logistics & Launch Excellence
Significant Work Activities: N/A
Travel: Yes, 25 % of the Time
Job Type: Experienced