IT Business Partner Resume Bedminster, NJ - Hire IT People

SUMMARY:

Current projects are development and enhancement of labeling systems, DMS, RIM systems, eTMF, R&D document management and electronic publishing processes and technologies
Deep knowledge of Regulatory submissions; publishing systems technologies and processes
Recently returned to Information Technology to establish GxP systems to support company’s move into branded products: computer systems procurement, validation, support

SKILLS:

Veeva (RIM, eTMF), Liquent Insight, Master Control, GLAMS, Documentum D2 and Webtop EDMS, Trackwise, ISI ToolBox, Confidential Electronic Submission Gateway, Accuta ARIM, Adobe Acrobat, SharePoint, All MS Office Applications including Project and Visio

EXPERIENCE

IT Business Partner

Confidential, Bedminster, NJ

Responsibilities:

Main responsibility is establishing and supporting Veeva Vault and Insight Publisher for submissions:
Established Veeva Vault, integrated with Insight for Publishing
Migrated 150k legacy documents from NextDocs and Share Points to Veeva
Established collaborative authoring software, template package tools and process
Led the project to establish Perigord GLAMS in support of label artwork
Managing the adoption of an SPL portal

Senior Project Manager

Confidential

Responsibilities:

Managing a project to migrate documents from both a legacy Documentum instance and soon - to-be-retired RIM system to a new Documentum D2 system for this global organization.
Led change management project to facilitate and document a global move to centralized data entry for RIMs

Regulatory Systems Specialist

Confidential, King of Prussia, PA

Responsibilities:

Launched, with EU clinical staff, the company’s first eTMF system based on Veeva Vault. I was responsible for identifying the solution to meet the requirements. The system was in Production 4 months after procurement
Implemented a global RIMS system, based on Trackwise from requirements gathering through validation managing ~12k new records annually and 20k legacy records from two retired systems. Final phase of the project involved Quality checking, report enhancement and IDMP planning for the system
Championed and launched the company’s first R&D global document management system, providing ‘one global version of the truth’ for documents destined for submission.
I led the project from requirements gathering through solution identification to rollout.
The company, formed from several smaller organizations, was without a compliant system for R&D submissions and audit support.
Led a team of six that implemented a global Regulatory document archiving system, reducing turnaround time on document retrieval from several days to under an hour
Established electronic publishing at the company’s headquarters. This entailed coordinating the processes of aggregating eCTD documents from four manufacturing sites. This system was used to submit a major BLA, which was approved in April 2013

Manager, Publishing Document Formats and Standards

Confidential

Responsibilities:

Pre-publishing services for a company producing on average four major and 1500 routine submissions /year.
Hands-on for all functions, including uploading and routing of documents and data files; formatting of documents to allow for publishing
Review and Approval processes; functioning as Document Specialist during extended staff absences
Every document was submission-ready when delivered to Publishing for the last four NDA/eCTD projects.

Manager, e-Submissions

Confidential, Jersey City, NJ

Responsibilities:

Established eCTD format and publishing tool as standards for INDs, NDAs, responses, annual reports and all other Confidential, partner and clinical site documentation, for 4 major and 1500 routine submissions/year. This ensured compliance with Confidential regulation and improved turnaround times by 25%.
Coordinated documents and data from therapeutic areas and CROs for four major concurrent publishing projects. Wrote training material and work instructions for all relevant processes.

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It Business Partner Resume

Bedminster, NJ

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