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Our client, a world-leading Pharmaceutical Company in Titusville, NJ is currently looking for a Business Analyst to join their expanding team.
Job Title: Business Analyst / UDI-Unique Device Identification / Pharma-Medical Devices Industry
Duration: 3 months contract, extendable up to 24 months
Location: Titusville, NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position title: Senior Analyst, DI&T, Regional Deployment
The Deployment Senior Analyst, Digital Identification & Traceability, will be a key role in the DI&T department within the Company Supply Chain organization, and report to the Regional Deployment Manager.
This role will be responsible for supporting the execution of different programs within the Unique Device Identification (UDI) Capability in Company, with a primary alignment to our MDR Program.
The resource will serve as a point of contact and have day-to-day operational interaction with with our Supply Chain partners, multiple business franchises and other functions as we execute our UDI Registration Readiness & Post Registration activities in support of the MDR program.
The scope of the current role includes:
Geographic Breadth
Regional (EMEA) support for primarily UDI, supporting as required our wider DI&T base business activities in the area of Serialization & GDS, and emerging product identification and tracking capabilities
Supporting global DI&T initiatives including shared systems and overlapping synergies to drive standardization and compliance
Business Breadth - All segments (Pharma, Consumer and Med Devices), End-to-End SC functions (Plan, Source, Make, Deliver, Quality), Commercial, IT, Data, Regulatory Affairs and Finance.
Levels of influence - Peers, Managers, Directors on a Global & Regional basis.
Key Responsibilities:
UDI EUDAMED Registration Readiness & Post Registration activities such as
EUDAMED Playground testing for all subsequent UDI & regression testing upon the release of other modules
Company submission solution (STUDIO) testing for inflight releases
Test Script documentation, execution and impact assessment on variations, data seeding
DI&T EMEA documentation development & Global documentation as required
Supporting Franchise Registration readiness activities including data issue resolution & if required, training delivery
Hypercare & ownership of EMEA UDI helpdesk tickets as Franchises transition to Base business
Process mapping
BUDI Generation Support to support increase in requests triggered by MDR
Assist Franchises to stay in sync with requirements when new data requirements and process changes arise
Partner with business leaders, Company Technology, Commercial, MAKE and DELIVER organizations to provide the highest level of data quality and enable efficient digital strategies for our customers
Own specific tasks as part of larger projects to ensure timely and within budget delivery while coordinating tasks across functions and geographies
Support the DI&T Product Owner teams,(UDI and GDSN), in the development of strategy, scope and plans for new market regulations, compliance requirements & data delivery requests to both create and take advantage of data enabled opportunities
Constantly driving our regulatory UDI compliance strategy within the Company Supply Chain to ensure key milestones are met for regional compliance to the laws and statutes relating to Serialization and UDI.
Qualifications & Skills:
A minimum of a bachelor's degree.
A minimum of Four (4) years of relevant business experience.
Supply Chain experience.
Ability to execute project tasks independently
Ability to build and drive progression of business metrics.
Ability to work in a cross-functional environment within a global supply chain.
Ability to lead and influence others in a sophisticated matrix organization.
Experience with standard MS Office applications (word, powerpoint & excel)
Excellent analytical skills & attention to detail
Excellent communication skills (written, oral, and presentation).
Ability to develop relationships and encourage confidence and trust from partners at all levels both internal as external.
This role may require up domestic and international travel on an exception basis.
Experience writing SOPs using good documentation practices
Experience with requirements definition & test script definition and execution an advantage
Past experience synthesizing large quantities of process and data/technical information and communicating clear recommendations to multiple organizational levels.
Some understanding of Serialization, UDI and/or GDS, with exposure to industry standards such as GS1 (Global Standards organization) being an advantage
Our client, a world-leading Pharmaceutical Company in Titusville, NJ is currently looking for a Business Analyst to join their expanding team.
Job Title: Business Analyst / UDI-Unique Device Identification / Pharma-Medical Devices Industry
Duration: 3 months contract, extendable up to 24 months
Location: Titusville, NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position title: Senior Analyst, DI&T, Regional Deployment
The Deployment Senior Analyst, Digital Identification & Traceability, will be a key role in the DI&T department within the Company Supply Chain organization, and report to the Regional Deployment Manager.
This role will be responsible for supporting the execution of different programs within the Unique Device Identification (UDI) Capability in Company, with a primary alignment to our MDR Program.
The resource will serve as a point of contact and have day-to-day operational interaction with with our Supply Chain partners, multiple business franchises and other functions as we execute our UDI Registration Readiness & Post Registration activities in support of the MDR program.
The scope of the current role includes:
Geographic Breadth
Regional (EMEA) support for primarily UDI, supporting as required our wider DI&T base business activities in the area of Serialization & GDS, and emerging product identification and tracking capabilities
Supporting global DI&T initiatives including shared systems and overlapping synergies to drive standardization and compliance
Business Breadth - All segments (Pharma, Consumer and Med Devices), End-to-End SC functions (Plan, Source, Make, Deliver, Quality), Commercial, IT, Data, Regulatory Affairs and Finance.
Levels of influence - Peers, Managers, Directors on a Global & Regional basis.
Key Responsibilities:
UDI EUDAMED Registration Readiness & Post Registration activities such as
EUDAMED Playground testing for all subsequent UDI & regression testing upon the release of other modules
Company submission solution (STUDIO) testing for inflight releases
Test Script documentation, execution and impact assessment on variations, data seeding
DI&T EMEA documentation development & Global documentation as required
Supporting Franchise Registration readiness activities including data issue resolution & if required, training delivery
Hypercare & ownership of EMEA UDI helpdesk tickets as Franchises transition to Base business
Process mapping
BUDI Generation Support to support increase in requests triggered by MDR
Assist Franchises to stay in sync with requirements when new data requirements and process changes arise
Partner with business leaders, Company Technology, Commercial, MAKE and DELIVER organizations to provide the highest level of data quality and enable efficient digital strategies for our customers
Own specific tasks as part of larger projects to ensure timely and within budget delivery while coordinating tasks across functions and geographies
Support the DI&T Product Owner teams,(UDI and GDSN), in the development of strategy, scope and plans for new market regulations, compliance requirements & data delivery requests to both create and take advantage of data enabled opportunities
Constantly driving our regulatory UDI compliance strategy within the Company Supply Chain to ensure key milestones are met for regional compliance to the laws and statutes relating to Serialization and UDI.
Qualifications & Skills:
A minimum of a bachelor's degree.
A minimum of Four (4) years of relevant business experience.
Supply Chain experience.
Ability to execute project tasks independently
Ability to build and drive progression of business metrics.
Ability to work in a cross-functional environment within a global supply chain.
Ability to lead and influence others in a sophisticated matrix organization.
Experience with standard MS Office applications (word, powerpoint & excel)
Excellent analytical skills & attention to detail
Excellent communication skills (written, oral, and presentation).
Ability to develop relationships and encourage confidence and trust from partners at all levels both internal as external.
This role may require up domestic and international travel on an exception basis.
Experience writing SOPs using good documentation practices
Experience with requirements definition & test script definition and execution an advantage
Past experience synthesizing large quantities of process and data/technical information and communicating clear recommendations to multiple organizational levels.
Some understanding of Serialization, UDI and/or GDS, with exposure to industry standards such as GS1 (Global Standards organization) being an advantage
