Key Role:

Serve as a subject matter expert in pharmaceutical drug supply chain policies and regulations to help lead the business requirements gathering as the client undergoes a transformation and modernization in the drug supply chain track and trace. Maintain responsibility for comprehending the policy impacts of the newly developed Drug Quality and Security Act as it relates to the regulatory implementation of the new standards in supply chain technologies. Integrate with the development team to define requirements, clarify questions, and assist with testing or coordinating activities across the team to ensure compliance as the client implements technologies supporting the Drug Quality and Security Act. Work with team members as well as contribute individually to the client in areas of pharmaceutical drug supply chain policies. 

Basic Qualifications:

-5+ years of experience in working with pharmaceutical supply chain policies and regulations

-Experience working with or as part of a pharmaceutical supply chain

-Experience interacting with FDA and pharmaceutical supply chain vendors

-Experience with using Microsoft Office tools, including Microsoft Visio

-Knowledge of current pharmaceutical supply chain data sources, policies, operations, risks, and practical solutions to implementing practices that adhere to regulatory requirements

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-Experience with Supply Chain Management with a pharmaceutical manufacturer or supplier

-Experience with Medical device Supply Chain Management

-Experience in working with data and technology modernization efforts

-Ability to guide enterprise solution development and work with a development team to coordinate priorities and perform impact assessments

-Ability to pay strict attention to detail

-Ability to recommend procedures when coordinating between systems development teams

-Possession of excellent verbal and written communication skills, including communicating clearly via all channels, such as phone, email, in-person, and written deliverables

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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