Sr Regulatory Affairs Specialist

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POST DATE 8/24/2016
END DATE 10/29/2016

Henry Schein Grapevine, TX

Company
Henry Schein
Job Classification
Full Time
Company Ref #
R101388
Location
Grapevine, TX
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree
AJE Ref #
575967499

JOB DESCRIPTION

SR REGULATORY AFFAIRS SPECIALIST



JOB OVERVIEW:


This position is responsible for ensuring that the company and its subsidiaries maintain DEA compliance. Provide guidance and expertise to Regulatory Affairs in consulting Federal, State, and local government agencies (i.e. DEA, FDA and State Pharmacy and medical boards)..


KEY RESPONSIBILITIES:


Research and analyze applicable laws and regulations, develop and implementthe necessary policies and procedures to ensure the Company's ongoingcompliance with Federal,State and local requirements.

* Conducts "Know your Customer" due diligence on customers intending to purchase controlled substances.

* Performs on-site due diligence audits on customers.

* Researches and analyzes laws and regulations to ensure that company's ongoing compliance.

* Develops appropriate compliance awareness training programs and conducts training for sales, field service distribution centers and corporate staff, consistent with regulatory compliance manuals.

* Provides guidance in developing regulatory policies and procedures, maintenance and updates, and appropriate control of documents.

* Provides advice and guidance to the company and its subsidiaries on necessary actions to maintain regulatory compliance.

* Conducts regulatory audits of distribution centers and subsidiaries.

In addition to the essential duties and responsibilities listed above, all positions are responsible for:



*Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including Worldwide Business Standards.

*Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.

*A minimum of three years of experience or the equivalent required in dealing with DEA regulations.

*Working knowledge of auditing requirements and techniques.

Ability to analyze problems and develop solutions, excellent communication and interpersonal skills, detail oriented and ability to work independently.

*Computer skills, including MS Word, MS Excel, flow charts, and obtaining information from mainframe databases, such as AS400.

*Prior Pharmacy, Medical or DEA experience preferred.

*Bachelor's degree or equivalent.



SPECIFIC KNOWLEDGE & SKILLS:



* Thorough understanding of regulations applicable to HS operations.

* Specialized knowledge on a specific Regulatory area.

* Strong understanding of manufacturing, distribution and auditing processes.

* General knowledge of ISO 9000.



TRAVEL/ PHYSICAL DEMANDS:



* Travel typically 10% to 50%.

* Office environment. No special physical demands required.






























Henry Schein, Inc. is an Equal Employment Opportunity Employerand 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, maritalor veteran status,or any other legally protected status

Overview

Henry Schein is the world’s largest provider of health care products and services to office-based dental, medical and animal health practitioners. A FORTUNE 500® Company (ranked #303) and a member of the NASDAQ 100® Index, Henry Schein employs more than 15,000 Team Schein Members and serves approximately 775,000 customers. Henry Schein also ranked number one overall in its industry in FORTUNE’s 2012 list of the “World’s Most Admired Companies,” number 10 in the Barron’s 500, and was named to Ethisphere’s 2012 list of World’s Most Ethical Companies. Henry Schein is organized in three global verticals: Global Dental, Global Medical and Global Animal Health. The Company offers a comprehensive selection of products and services, including value-added solutions, enabling customers in more than 200 countries to operate efficient practices and deliver high-quality care. The Company also offers its customers exclusive, innovative technology solutions, including practice management software and e-commerce solutions, as well as a broad range of financial services. In addition to office-based practitioners, Henry Schein also serves dental laboratories, government and institutional health care clinics, and other alternate care sites.

Company Size:
5,001-10,000 Employees
Industry
Healthcare
Founded:
1932
Social Media:
Headquarters:
135 Duryea Rd
Melville, NY

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