Spec Licensing

Medline Industries, LP

2d • $73,000 - $110,000

About The Position

Job Summary Responsible for planning and executing regulatory activities and projects necessary to ensure compliance with state and federal licensing requirements for the distribution of drugs, medical devices, and other regulated products. Assist with development of policies and procedures, systems, and strategies related to regulatory licensing compliance. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete department goals. Job Description Responsibilities In support of business priorities, determine the requirements for obtaining and complying with state and federal licenses for the distribution of prescription drugs, medical devices, home medical equipment, and other regulated products. Prepare, complete, and submit licensing applications and documents to state and federal regulatory agencies. Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities. Develop and implement improvements to processes and procedures related to licensing requirements. Communicate the requirements of regulations to internal or external customers Prepare routine reports, dashboards, and summaries for licensing compliance tracking. Collaborate with cross-functional teams to deploy quality processes and systems. Implement and coordinate the use of electronic documentation systems and train personnel. Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert. Provide training to team members and other internal departments on Medline licensing procedures and processes.

Requirements

• Bachelor’s degree or a combination of education and experience
• At least 2 years of experience in regulatory affairs, licensing, quality assurance, quality, compliance, or legal.
• Knowledge / Skills / Abilities
• Intermediate skill level in Microsoft Suites (Excel, Word, Visio, Access, PowerPoint, Project).
• Ability to evaluate information to determine compliance with standards, laws, and regulations.
• Experience with Quality Management Systems and Document Control.
• Applied knowledge of state pharmacy/ wholesale drug distributor laws, NABP Drug Distributor Accreditation, FDA regulations, DSCSA, and other laws and regulations related to drug and medical device distribution.
• Experience collaborating with internal resources and external resources.
• Experience working through details of a problem, overcoming obstacles, and reaching a positive and successful solution

Responsibilities

• In support of business priorities, determine the requirements for obtaining and complying with state and federal licenses for the distribution of prescription drugs, medical devices, home medical equipment, and other regulated products.
• Prepare, complete, and submit licensing applications and documents to state and federal regulatory agencies.
• Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities.
• Develop and implement improvements to processes and procedures related to licensing requirements.
• Communicate the requirements of regulations to internal or external customers
• Prepare routine reports, dashboards, and summaries for licensing compliance tracking.
• Collaborate with cross-functional teams to deploy quality processes and systems.
• Implement and coordinate the use of electronic documentation systems and train personnel.
• Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.
• Provide training to team members and other internal departments on Medline licensing procedures and processes.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees