Director of Regulatory Affairs
Healing patients starts with you. It starts with the chain of events you initiate when you work with McKesson Medical-Surgical - a chain that extends across the country and results in millions of people getting more from their healthcare.
Headquartered in Richmond, Virginia, McKesson Medical-Surgical is the leading distributor of medical-surgical supplies, equipment and supply chain solution services. We're also a technological leader in the industry, developing products and services that improve processes and enhance quality and efficiency. We have 25 distribution centers across the country, employing more than 4,000 associates. We stock and distribute over 150,000 products and serve more than 85,000 customers. We're proud to be the only national distributor serving the entire continuum of healthcare. But we're especially proud to be the company our customers and their patients count on for solutions to their healthcare supply management needs.
Current Need
The Director of Regulatory Affairs (¿Position¿) is responsible for providing both professional and regulatory oversight and support to the McKesson Medical-Surgical Companies (¿Company¿) by maintaining, anticipating, and coordinating all activities with Federal and State governmental agencies affecting distribution operations to enable compliance with all applicable State and Federal regulations and laws. The Position will stay up-to-date, as much as possible, with the following laws and regulations through proactive monitoring of the Federal Register and other sources and through continuing education:
¿ Dept. of Justice, Drug Enforcement Administration (DEA)
¿ Food and Drug Administration (FDA)
¿ FDA Prescription Drug Marketing Act (PDMA)
¿ Department of Transportation (DOT), and comparable State DOT's
¿ Federal Aeronautics Administration (FAA)
¿ Environmental Protection Administration (EPA)
¿ Occupational Safety and Health Adm. (OSHA)
¿ State Boards of Pharmacy, Department of Health, Medical Boards, etc.
¿ State Workers Compensation Administration Programs
Position Description
Oversee regulatory compliance across the Company through the following responsibilities:
¿ Ensure that applicable state and federal licenses and registrations (including state board of pharmacy licenses) are obtained and maintained for all distribution centers and maintain communications as needed with all of the respective federal and state agencies.
¿ Supervise, direct and train Regulatory Affairs Department staff to assure quality customer service and nurture the staff¿s objectivity, integrity and commitment to compliance.
¿ Supervise and direct OSHA Safety and Compliance and the Workers Compensation program.
¿ Review web/catalog/promotional pharmaceutical content for accuracy.
¿ Respond to subpoenas and requests by State and Federal regulatory agencies as required.
¿ Provide guidance and direction to the Chief Compliance Officer, the Law Department, Senior Management, and Corporate and Field operating units to enhance compliance with Federal and State laws and regulations.
¿ Maintain membership and participation in Industry and Governmental organizations as a conduit for increasing knowledge, relationship building with governmental agencies and providing Company-centric input into proposed legislation, and function as a Company representative on McKesson¿s Regulatory Affairs Council.
¿ Direct and assist our Corporate and Operating units in managing, negotiating and responding to governmental inspections thereby minimizing the risk of violations, punitive actions, and monetary fines.
¿ Guide the Company (e.g., all Distribution Center, Sales, and Corporate managers) to develop and maintain a process for obtaining current Customer Licensing/Credentials to enable Customers¿ appropriate purchase of regulated products.
¿ Coordinate the Company¿s DEA controlled substance program to enable Distribution Center compliance with state licensing and pharmacy and medical board regulations
¿ Provide guidance and direction to the Company to ensure that regulatory requirements are incorporated into the development of the Company¿s systems and processes, (e.g., JDE development, electronic MSDS project, pharmaceutical marketing program, electronic DEA process management, pedigree matters).
¿ Coordinate the Verified-Accreditation of Wholesale Distributors® (VAWD) programs across the Company¿s distribution centers, as applicable, and function as the main contact with VAWD officials and inspectors.
¿ Function as the Company liaison with federal and state regulatory agencies.
Coordinate and Develop Written Standards to demonstrate the Company¿s awareness of and intention to comply with applicable laws and regulations through the following responsibilities:
¿ Guide and coordinate the development and maintenance of Standard Operating Procedures for the Company¿s distribution centers as they pertain to the compliance with applicable laws and regulations.
¿ Develop and maintain a written Company product recall process to ensure that recalls are communicated promptly to affected Company personnel, Customers, and the FDA.
¿ Provide input and coordinate various written procedures pertaining to, for example, Prescription Drug Marketing Act compliance, DEA compliance, License maintenance.
Develop, in collaboration with the Compliance Ethics Audit Manager, auditing monitoring programs to include but not limited to the following:
¿ Ensure the validation of appropriate licenses and quantities for all customers who purchase regulated product in accordance with Company policy.
¿ Review customer order patterns of controlled substances, regulated chemicals, and Rx product quantities to detect red flags that may be demonstrate a pattern of abuse and diversion.
¿ Monitor the DEA- registered distribution centers to validate compliance with all applicable DEA and the Automation of Reports and Consolidated Orders System (ARCOS) regulations, records, and reporting requirements.
¿ Conduct and/or direct regulatory, safety, and training compliance audits at distribution centers.
Develop and implement training and education programs to include but not limited to the following:
¿ Provide Hazardous Materials Management (¿HazMat¿) training to all applicable Distribution Centers personnel thereby helping to maintain a positive corporate relationship with UPS Corporate Regulatory Affairs to minimize shipping suspensions and customer service interruptions
¿ Develop and provide employee safety training programs to comply with federal and state regulations thereby enhancing employee safety and well being and reducing the Company's cost related to Workers Compensation administration.
¿ Develop and implement employee awareness and/or training programs to familiarize employees with key regulatory requirements (e.g., customer license requirements, product recall policy, product incident reporting and management).
Responsible for managing the activities of departments which ensure the company is aware of all appropriate regulations and rules in compliance with regulatory obligations. Oversees the interpretation of federal, state and/ or international regulations as they apply to products, processes, practices and procedures. Responsible for implementation of policies and procedures to comply with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met. Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. May develop and implement programs designed to increase employee awareness and knowledge of compliance policies. May audit and evaluate current policies, procedures, and documentation for compliance with governmental laws and regulations. May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
Additional Knowledge Skills
¿ Multiple years of management experience responsible for regulatory compliance, in the pharmaceutical/medical device industry
¿ A strong working knowledge of distribution field unit operations and the applicable governmental/regulatory issues
¿ Experience in managing people and possess excellent people management skills
¿ Specialized Knowledge/Skills ¿ Be certified as a US DOT CFR-49 HazMat certification trainer.
¿ Possess basic level computer skills.
¿ Knowledge of pharmaceuticals including manufacturers, dosage forms, drug information, etc.
¿ Understanding of Compliance Program fundamentals
¿ Proven ability to manage multiple tasks/projects
¿ Excellent verbal and written skills
¿ Excellent interpersonal and communication skills
¿ Strong organizational skills
¿ Ability to work independently, in a self directed manner
¿ Ability to comprehend complex legal matters
¿ Demonstrated experience in working collaboratively in cross-functional and cross-divisional teams or solving cross-functional/cross-divisional issues in a manner that not only demonstrates both strategic and tactical thinking, but also in a manner that builds, maintains, and enhances a positive working relationship
Minimum Requirements
Minimum 5+ years of related regulatory affairs experience drug and medical device distribution specializing in federal and governmental regulations including 2+ years of people managerial experience. Desired backgrounds may incude healthcare, medicare, pharmaceuticals, biologics manufacturing, or clinical research.
Education
BA/BS degree required. Masters Degree preferred
Physical Requirements
Nationwide air travel (20 to 40%) and the ability to endure all types of weather and travel situations
Be able to work in office and warehouse environment
Be able to work standing for long periods of time
Agency Statement
No agencies please.
The material contained herein is provided for informational purpose only. All open jobs offered by McKesson Corp. on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.
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