Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Dublin, Ohio
STATE LICENSING AND LABELING INTERN
All drug wholesalers must be licensed under state licensing systems, which must in turn meet the FDA guidelines under State Licensing of Wholesale Prescription Drug Distributors (21 CFR Part 205). The regulations set forth minimum requirements for prescription drug storage (21 CFR Part 205. 50 [a] and [c]) and security (21 CFR Part 205. 50 [b]), as well as for the treatment of returned, damaged, and outdated prescription drugs (21 CFR Part 205. 50 [e]). Further, wholesale drug distributors must establish and maintain inventories and records of all transactions regarding the receipt and distribution of prescription drugs and make these available for inspection and copying by authorized federal, state, and local law enforcement officials (21 CFR Part 205. 50 [f]).
This position will help analyze and ensure that HSAH is compliant with all federal and state laws on all licensing requirements for wholesale distributors. Will interface with Operations, Procurement, Credit and Sales & Marketing to help resolve any regulatory licensing issues and ensure that private brand labeling is compliant. Will work in cross-functional teams and support regulatory strategies in meetings.
Assist in the filing, review and tracking of all federal and state licensing required for all operational distribution centers within HSAH.
Assist in the filing of new state licenses as needed and ensures that required state licenses are maintained and renewed annually prior to their expiration date.
Create, maintain and manage the state licensing tracking software to ensure all licenses are up-to-date and renewed prior to their expiration date.
Work closely with HSAH manufacturers and to obtain copies of their license that will need to be reviewed and tracked to ensure that they are compliant with all federal and state laws when shipping products to HSAH distribution centers.
Prepare and submit monthly reports regarding status of all HSAH federal and state licenses in order to demonstrate compliance and report to management.
Assist and review HSAH private brand products and marketing materials while ensuring compliance with FDA and Office of Prescription Drug and Promotion requirements.
Works closely with the Regulatory Manager to update Department Standard Operating Procedures (SOPs).
Prepares and presents regulatory documents and presentations for internal and external meetings
High school diploma or equivalent required
Must be currently enrolled in a post-secondary program
Strong PC skills with proficiency using Microsoft Office Package (Excel, Word, and PowerPoint) and Outlook e-mail.
Good analytical, problem-solving, time management, organization, and negotiation skills.
Good oral and written communication skills with a focus on delivering excellent internal and external customer service as well as the ability to operate as a team member.
Strong computer typing skills.
Able to meet timelines
Henry Schein Animal Health offers a comprehensive total compensation and benefits package that includes medical, dental, and vision insurance, 401(k) with a generous company match, company paid life insurance and AD&D coverage, educational assistance, and much more!
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.