Supply Chain Security Partners
The individual will be responsible for developing and managing the Traceability Regulatory Activity Service. The service is a cloud‐based business intelligence application intended to serve clients succinct and meaningful information on existing and emerging traceability regulations across pharmaceutical and medical device sectors of global healthcare.
Specific responsibilities include, but are not limited to:
- Track and capture global traceability requirements. Works with internal and external regulatory affairs and public policy functions to gather requirements. Explores and becomes fluent in various notification sources, finding corroborating information from multiple sources, and obtaining clarification on requirements and timing.
- The BA will interact with industry peers, supply chain partners, standards bodies (e.g., GS1), and associations in the areas of traceability and regulation. Incorporate intelligence and insight gathered from industry to enhance the service and improve on the value of the content.
- Develop a client notification and vetting process to capture new information on regulations, rapidly assess and determine courses of action for the service and communications to clients.
- Work in partnership with the part‐time Regulatory Expert on interpreting regulations, documenting requirements and crafting the applicable content for clients (MS Word, PDF, PPT, Web).
- Create and present to clients content included within the service via Webinars and private teleconferences. Working with the Regulatory Expert, create responses to regulatory agency dockets and calls for comments.
- Coordinate the onboarding of new clients to the services ensuring efficient use of client time for training and help‐desk type support.
- Capture new business needs from clients in scope for the services. Work with project director on opportunities to improve the services and create plans for implementing improvements.
- Contribute to solution development for the service and serve as the primary business owner for future improvements and enhancements.
- Diligently work to improve the service by incorporating adjacent regulatory requirements such as Tamper Evidence, Anti‐Counterfeiting and similar national mandates intent on improving patient safety.
- 8‐10 years’ experience in operations, quality assurance or regulatory in the Consumer Healthcare, Pharmaceutical, Biotech or Medical Device industries is required.
- Strong written and oral communication skills, self‐directed and proactive.
- Ability to be flexible and change activities quickly, based on business need
- Ability to facilitate meetings and follow up with resulting action items
- Ability to travel globally as required
- Proficient knowledge of MS Excel, Word, Outlook, PowerPoint.
- Visio and MS Project experience.
- Experience with Serialization traceability regulation a plus.
- Previous regulatory experience preferred.
- Experience with pharmaceutical operations, supply chain and healthcare providers.
- Experience working in central/regional above‐site operations
- Ability to work in a team‐oriented, collaborative environment – at times taking direction from senior associates and project managers.
Education / Experience
A minimum of a Bachelor’s degree in the science, technology, engineering or math. Healthcare regulation experience is highly desirable due to the nature of the service.
Delaware, Eastern, PA or Central and Northern NJ preferred. Colleague can be located remotely.
A Notebook PC may be provided on loan to the resource if required.
This is a full time contract position with option to hire as an employee.