Nimesh Patel Email & Phone Number

Warren, Nj, Us

Washington, District Of Columbia, Us

Washington, Dc, Us

Nutley, Nj, Us

Currently Responsible for:• Collaborating with, and developing cross functional strategies with internal business stakeholders.• Developing business strategies that support effective change management within Regulatory and adjoining business units• Negotiating contracts for projects that may include additional resource, or system implementation.• Overseeing continuous development of a technical System Roadmap to ensure the alignment of Eisai’s business with the changing industry landscape.• Responsible for the execution and delivery of Regulatory systems projects (new implementations, upgrades, and enhancements). • Translate global RIM-related regulations into meaningful business requirements and solid action plans to support current and future RIM initiatives

Nutley, Nj, Us

As the AD of R&D business applications supported critical business applications and delivered key programs for all line of business functions viz. Clinical Operations, QA, Regulatory, and Safety. Lead Developed IT strategy, tactical plan, capability road map and implemented critical IT Systems through business partnership.Led global programs in the area's of Safety Platform upgrade, Regulatory Submission & Publishing Upgrade, Regulatory Tracking Implementation, QMS & QDocs deployments.

Nutley, Nj, Us

Implemented a SaaS base Safety Solution platform to support the global Pharmacovigilance organization. Solution offered PV employees a single point of access to safety information from all regions within Eisai. Enabled the organization to stay update on latest guidance changes impacting case reporting. Oversaw a small Support Team (10) resources (3 on-site) / 7 remote supporting wide variety of Regulatory, Clinical & Quality systems. Support Senior IT leaders in establishing an IT strategy linked to business strategies and ensure necessary IT resources, initiatives and platforms are in place to support company growth.

Dublin 2, Ie

Manager within the Veeva RIM (Regulatory Information Management) practice. Lead RIM implementations, provided strategic advisement, and support within pharmaceutical, biotech, medical products, CRO and consumer health business sectors. Served as a subject matter expert in the areas of Regulatory, Quality, Laboratory Automation and Clinical for leadership.

Aventura, Florida, Us

Primary role is a strategic IT liaison between the clients and the RxLogix organization. Building strong partnerships and delivering operational, strategic and meaningful IT solutions. Act as a change agent to align the IT portfolio with business strategy, the IT strategic plan and corporate IT architecture, and is responsible for communications between the Development business areas and other IT. Lead the Corporate Quality function for content management, records information management, mgmt. of global quality procedures & policies, internal / external auditing and data governance and standards.Provide Project Management service to clients for onsite and hosted implementation. Utilizing either Agile or Waterfall methodologies in delivery. Develop Project Mgmt. plans, communication plans, status reports for Sr. Leadership.

East Norriton, Pa, Us

Serve as a IT lead within the R&D Practice for selected Global Life Sciences companies. Manage mid to large complex IT programs and provide expertise in business/capability process mapping; technology rationalization strategies, regulatory & compliance strategies, analysis, project management, and business process development.

Lawrence Township, Nj, Us

Manage the deployment and expansion of BMS's Argus program. Coordinate the effort for Argus Platform Stabilization, to ensure the reduction of critical incident and enhancements. Also served as the programs lead for the expansion of Argus J to Japan and retirement /migration of legacy Japan Safety systems. Effort included designing a stabilization process; 24/7 Tier 1 level help desk for Japan users; capability road maps for the PV & Safety groups for next 12-24 months.

Dublin, Ie

Managed an IT R&D Portfolio for all of Actavis's 40+ Manufacturing and 30+ Laboratory sites world wide. Work with global site teams to support IT systems on production floors; coordinated with site teams to engage vendors for support / deployment of systems and equipment. Managed internal and external staff on various SDLC related projects, utilizing both Agile and traditional waterfall methodologies for deployment of systems. Provided monthly metrics on program / project health to Sr. Leadership and managed the R&D IT budget.Delivered two key Enterprise based platforms Global Labware LIMS for the Quality and Compliance organization and Global POMSnet for Clinical Manufacturing and Packaging Organization.Reduce the IT footprint by sun-setting / archiving legacy systems through various M&A and corporate restructuring programs, resulting in $1M maintenance savings. Also resulted in providing a framework in developing a global mfg and laboratory IT landscape to allow scalablility and expansion.Develop Capability Road-maps for the R&D portfolio in which become the driving mechanism for Sr. Leadership in IT and our Business partners to discuss critical programs and opportunities at QTR and Fiscal year level.

Us

Responsible for estimating project scope, budget, resources, work plans and schedules to support project proposal / business case development and for leading projects through the entire systems development lifecycle including tracking and monitoring project progress, planning testing and deployment (roll out) activities, and ensuring that the systems are properly implemented in accordance with GxP validation and internal company standards.*Lead cross functional teams in development of resource requirements and costs for IT projects*Negotiate contracts with external software and consulting vendors*Manage internal project resources and external contract resources*Develop and review project documentation*Explain system SDLC, techniques and standards to both internal and external parties*Provide oversight on project management phases and provide counsel and risk oversight for the project*Communicate to clients and partners at both the technical and/or functional level*Provide performance feedback on staff assigned to projects