Regulatory Operations Analyst Jobs

Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

Under general supervision of the Manager – Regulatory Operations, responsible for product recall notification processing. Notifying vendors to support Internal Regulatory discoveries of suspect products. In support of Regulatory Operations Requirements, provides notification of suspect products to required parties. Provides process and analytical support for the Strategic Global Sourcing team, ensuring manufacturer performance and AmerisourceBergen objectives are aligned. Provides support to Manufacturer Operations to comply with the REMS requirements outlined by the FDA. Recommends and contributes to improved strategies in order to improve margins as a result of these efforts. Demonstrates excellent verbal and written communication skills with internal and external Partners, Manufacturers, and Customers.

• Perform assigned reporting functions for department.
• Under supervision, respond occasionally to inquiries from Governmental Agencies related to recall notification processes and documentation.
• Ensure documentation audit trail is maintained for activities conducted to support all product recall/withdrawal events.
• Work with internal stakeholders to assist with research and/or validate information provided in support of the agreements.
• Perform business activities used to validate details, manage applicable data, and create notification documents used to properly communicate Manufacturers' product recall /withdrawals notifications to key stakeholders, including distribution centers and external customers.
• Independently review incoming Manufacturer product recall and/or withdrawal notices to assess what actions are required to support removal of product from the supply chain and ensure that all information needed to support notification activities is obtained.
• Escalate issues to proper channels and work with technical resources to promptly address any problems.
• Ensure data accuracy and integrity of managed information is maintained for all supported processes in order to avoid rework.
• Responsible for maintaining documentation of department procedures, including recall notifications process and inventory and sales report setups.
• Collaborate with team members in order to continuously look for opportunities to improve processes and participate in user testing activities for system enhancements.
• Provide additional process support as needed for key department functions such as REMS audits, and suspect product notification.
• Interact extensively with other internal departments throughout the corporation in order to handle inquiries, provide information, research and resolve issues, and to support cross functional projects; rapidly detects and corrects problems ensuring root cause of issue has been addressed.

What your background should look like

• Knowledge of ABC policies, programs & services and products
• Ability to meet deadlines
• Working knowledge of purchasing, inventory management, order processing, invoicing, customer returns, receiving, Manufacturer returns and inventory control systems
• Strong interpersonal skills
• Problem-solving skills; ability to resolve issues effectively and efficiently with general supervision
• Strong analytical skills
• Normally requires one (1) to two (2) years directly related and progressively responsible experience.
• Strong organizational skills; attention to detail
• Excellent data entry and computer application skills
• Strong mathematical skills
• Ability to communicate effectively both orally and in writing
• Technical and analytical skills
• Ability to implement processes resulting in satisfactory audit practices
• Requires broad training in fields such as business administration, accountancy, sales, marketing, computer sciences or similar vocations generally obtained through completion of a four year bachelor's degree program or equivalent combination of experience and education.
• Demonstrated knowledge of systems, processes and procedures

What AmerisourceBergen offers

We offer a competitive total rewards package which includes benefits and compensation. Our commitment to our eligible population of team members includes benefit programs that are comprehensive, affordable, diverse, and designed to meet the needs of our team members’ and their families. Some of these programs include paid time off including paid parental leave, access to retirement savings vehicles, medical, dental, vision, and life insurance options, an employee stock purchase program, and other financial, health, and well-being focused benefits.

Because we take a balanced, global approach to our benefits, benefit offerings may vary by location, position, and/or business unit. Some benefits are company-paid, while others are available through team member contributions. For details visit https://www.virtualfairhub.com/amerisourcebergen.

Schedule

Full time

Affiliated Companies

Affiliated Companies: AmerisourceBergen Services Corporation

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

AmerisourceBergen is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned