YJP is committed to building a platform & support system for Jain professionals across North America and works to increase the awareness and understanding of Jain principles and heritage by promoting networking among Jain professionals.

Project: Open Text Authoring Content Management Implementation Participated in the product and Vendor selection, which included RFP and SOW finalization of ~$25 MM project On point for the project RAID log, Product Gaps log and Change Management trackerOverlooked the activities of Requirement, Platform and Integration workstreams to mitigate project roadblocks Led the integration of this global Authoring DMS systems with CTMS and eTMF to streamline data security and data migration across systems based on the study design and milestonesSr. Business AnalystProject: Regulatory Submissions Archive (Veeva Content Mangement System)Implemented an enterprise-wide solution to archive 60,000 submission records of 100 products for 7000 users.Acted as a SME to lead change control, security, UAT & migration planning processes in a 30 associate project team.Facilitated key decision making meetings to ensure correct and timely outcomes that kept the project on schedule.Created road-map to attain a solution that integrates all submission processes resulting in time and cost efficiency.Project: Veeva Vault Business Contract Management SolutionDeveloped an internal team to implement current and future Veeva BDL enhancementsManaged project plan and reported project status to the LTGuided the team to follow SDLC processes to comply with validation requirements

Project: World-wide Medical AffairsEvaluated existing SDLC methodology to streamline Grants project, enabling solution delivery in 14 weeks.Integrated global medical reporting platforms to optimize strategy setting and performance management efforts.Launched a tool that enables payers to understand the value-add of sponsoring MS patients.Validated calculations of a reporting dashboard to ensure leadership gets accurate information on MSL’s performance.Project: Regulatory Operations (Submission sciences)Improved submission tracking process to ~50 global regulatory agencies, producing ~20% time savings.Delivered ‘to be’ analysis for un-housed GXP documents to ensure audit-ability as per regulatory guidelines .Planned successful retirement of Veeva vault submission system, producing cost savings of $0.2M/year.

Client: Parnter Healthcare CImplemented solution enabling agents to WFH, solution allowed call center to be functional during extreme conditions. Reducing average handle time/call by 15 sec and provided 100% call record capability for reporting and training. Facilitated 3 years’ worth historical data migration into cloud based solution ensuring HIPAA compliance.Client: Iroko Pharmaceuticals Project: Commercial OperationsIntegrated DMS with CRM to enable sales team to access key documents that would enhance sales communications. Recognized a need to have e-signatures to ease the business process, solution resulted in 10% time saving. Analyzed requirement to track and report value spent on prescribers to comply with the Sunshine Act.Client: Usciences Evaluated ~6500 student performance trend based on 12 rubric skills from 2011 to 2014 for accreditation reporting. Outlined offshoring trends for active clinical trial site (phase 2 and 3) in 151 countries from 2008 – 2012. Published "Trends in the location of Phase 3 clinical trials between 2008 and 2012" in Pharmaceutical Medicine Journal (January 2016).Client: Aclaris Therapeutics Effectively analyzed pricing and indication based marketing strategies for in-development drug product.Demonstrated incremental ENPV of $41 million for expanded indication for a Seborrheic Keratosis treatment. Exhibited ENPV positive when Warts treatment hits peak market share of ~166,389 patients (25%).Client: Iroko Pharmaceuticals Examined the market penetration strategy and co-pay offset scheme for the first in line painkiller product.Compared sales trends of 2 major class of painkillers based on 7 regulatory guidelines for 50 states.

Oversaw communication between multiple departments to plan and maintain the annual turnover of $1.1MM. Simplified manufacturing operations for over 35 different products and 200 employees