Direct Hire – Senior Associate, Global Regulatory Systems & Process Mgmt (19-00203) – NJ – Woodcliff Lake

The Sr Associate, Global Regulatory Systems & Process Management (GRSPM) will support GRSPM Head with management and coordination of systems and process within Global Regulatory Services and Operation team. This position will support Regulatory Systems initiatives contributing directly to the value of Global Regulatory Operations, and responsible for oversight and local level systems support for Global Regulatory Affairs. This position will also contribute to Process Excellence by evaluating, developing and providing input into existing and proposed processes. We are looking for a solution oriented person who ensures that deliverables and key submission targets are achieved according to the quality standards of Client’s standard operating procedures.

1. Ensure that Regulatory Information Systems are supported and managed according to business need, including, but not exclusively, FirstDoc, eCTD Express, Submission Viewer, SharePoint

2. Submission Management Support

3. Delivering Training to Business Users

4. IT Liaison(Change and Request Management)

5. Vendor Management (Change, Request, SLA and Compliance Management)

6. Engage with vendors and internal partners to drive future state of-the shelf software packages

7. User Requirement Gathering and Dissemination, Process Design

8. Service Request Management

9. Gathering Business Feedback and Group Activity/Initiatives

Job Qualifications
• BA/BS in Computer Science or related discipline is required.
• Minimum 3 years of experience specifying and implementing new IT systems, and 1-2 years of regulatory information management systems experience
• Previous experience in pharmaceutical industry an advantage
• Experience with Systems, in particular in relation to Document Management, Regulatory Tracking and Publishing is beneficial
• Knowledge of Regulatory and Submissions processes in the EU and US is also important, especially with knowledge for key Regulatory systems and report publishing
• Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus
• Experience of mapping User Requirements to Functional Specifications especially in respect of process management an advantage
• 1st and 2nd line experience support around regulatory systems
Source: Job Diva – Job Listing

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