Hotlist-Hotlist Urgent requirement for Business Process Expert in New Jersey

Hi,

 

This is PRAVEEN from Deegit Inc. Please find the below requirements for your review. Appreciate if you could send us your qualified consultant for review. Request you to send us your consultant's HOTLIST so that we can get back to you with our direct client open requirements.

 

Role: Business Process Expert

Location: New Jersey

Duration: 1 year

 

Job Description:

A highly experienced business process expert / professional that will partner with Global Regulatory Affairs to ensure business strategies and technology solutions are implemented.

• Subject matter expert for the Global Regulatory Submission computerized system for countries like US and Europe.

• Expert skills in electronic document and content management systems (e.g. FirstDoc, and document lifecycle management)

• Working knowledge of electronic submission regulations and guidance, including 21CFR Part 11

• Working knowledge of validation requirements and processes

• Working knowledge of submission publishing tools (ISI publishing tools, Core Dossier, SPL authoring)

• Individual to have extensive hands on experience in understanding regulatory project scope.

• Actively participates in the development of procedures and training materials for the computerized system driving business process decisions.

• Serves as advocate to teams and functional areas for regulatory initiatives such as:

Global product nomenclature solution; Product registration tracking system; Submission document management solution; and submission publishing solution

• Should have complete understanding of the Regulatory Solutions Life-cycle Team (RSLT) participates in the planning, implementation, validation and life cycle management of GRA computerized systems.

• Manage the development and implementation of robust business practices to apply regulations, guidance's and best practices for RA and customers

• Critically evaluate existing processes, identify inefficiencies, recognize opportunities and optimize, where necessary

• Identify priorities and key issues in complex situations, and solve problems with minimal supervision

• Identify opportunities and threats within scope of responsibility and escalate to RA and Customer management appropriately

• Anticipate and proactively plan for expectations of Regulators

• Take initiative to determine impact of emerging threats, such as technological advances, guidance changes and competitor positioning

• Evaluate alternatives and recommend viable solutions to critical issues

• Demonstrated ability to work effectively in a large team environment and communicate with team members and customers at all levels of the organization.

 

 

 

Regards,

Praveen | Deegit Inc |

1111 Plaza Drive, Suite 370 | Schaumburg, IL 60173 |

Ph: 847.874.7081/82/3615 ext - 331 | Fax: 847.330.1987

praveen@deegit.com | www.deegit.com |

 

GMI: praveen.deegit

YMI: praveen.deegitac

 

"GSA Approved - GS-35F-0405V"
"Certified Minority Business Enterprise (MBE)"
"Winner - Deloitte Technology Fast 500 for 2008"
"Winner - Inc. 5000 fastest growing firm for 2008"

"Winner - Inc. 5000 fastest growing firm for 2009"

 

"Right Person for the Right Job in the Right Time"

 

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