ADC Consulting is a full breadth product development services and IT consulting company that combines deep domain expertise and cross-industry experience.ADC is thriving on creating innovative products and disruptive technologies. Our vision is to provide cost effective, scalable and user centric product solutions and services. We are a young and energetic TEAM built by industry leaders and free thinkers with broad stack of techno-functional capabilities.My role is to develop strong product base for Healthcare and Medical Technology in ADC.

GlobalLogic is an offshore software R&D services company that was founded in 2000. GlobalLogic provides full-lifecycle product development services, including software product design, product development, quality assurance, product support and consulting services. I have been a part of GlobalLogic since Jan, 2014 and consult on the Business Analysis part for a big Medical Device manufacturer. I am responsible for advising on the subject matter for the development of Medical Device software and elucidation of complex scientific requirements, and, work as a liaison across Business owners and the Delivery team to facilitate successful execution of deliverable.I study key business issues by interacting with the internal and external business units, organize stakeholder meeting, workshop, strategic meet up, scrum escalation meeting, requirement review meeting, JAD etc and provided clear and timely analysis / recommendations and improvements to the stakeholders, supporting operations and related processes, provide gap analysis and process optimization.I am engaged in managing product risk and generation of risk response (CAPA) using statistical techniques (using different quality tools and RCA), reviewing test plans to ensure that all requirements are addressed by the test procedures and validation process. I am also engaged in conducting Quality Reviews, Documentation Reviews including SOP reviews, designing and monitor test cases, user scenarios, test plans etc. I am responsible for training and directing the team for domain and thereby enhancing Healthcare and Medical Device domain competency in the organization.

Mindteck is a global technology company established in 1991 that provides Product Engineering solutions and Information Technology services. I joined Mindteck in to look after the Medical software compliances and double up to establish a Healthcare-Pharma vertical in the organization and Head the medical data management group. The goal was to understand the pain areas in Medical Device and Healthcare related software and develop one stop, client specific, enterprise class solutions. As a part of the pre-sales practice team, I was responsible to acquire new customer for Healthcare and Medical technologies. I was engaged in Providing Solution Design and Proposal. I designed product lines for Medical Device software, Clinical Trial systems, Laboratory Information Management system (LIMS) and, Healthcare systems (EHR and EMR) and HCP aggregate spend data and reporting system.For individual accounts, I took care of stakeholder management, Requirement Analysis, Risks Management etc and provided Logical Architecture and Mathematical Design for certain products and assisted in computer system validation etc. I have given regulatory compliance guidance for 21CFR (Part 11, Part820, Part 807, Part 814 etc.), 520(k)/PMA process, GDP, GLP and GMP, EDI transactions and code sets, HIPAA, PHI, PPACA, HCP(O) Aggregate Spend, HITECH, CDISC (SDTM and ODM), ISO 9001, ISO 14971, ISO 13485, IEC 62304 etc.I was engaged in establishing Operational Excellence that would evolve the team from the lift man step to process transformation by introducing business value articulation. This includes addition of systems for performance management, metrics reporting, invoice, escalation, handling SLA and service metrics, employee idea process etc.I was responsible for training stakeholders for domain related issues and representing the organization in international seminars and conferences etc.

I was in charge of providing the scientific knowledge and requirement elucidation for Clinical Trial Monitoring and Clinical Data Management software project (for various neurocognitive drug trials) in Ascendum. My core responsibilities are to facilitated functional decomposition of requirements, interface analysis, functional and non-functional requirement review and analysis at various interfaces of project development, documenting requirement risks, analyzing challenges and risks in eliciting requirements.I was involved in analyzing business rules, assessing the client, modeling data, analyzing decisions, analyzing documents. Creating organizational models, scope models and mind maps, designing risk strategies and creating risk responses etc. I developed domain specific use cases, business rules, class models and conducted quality assurance testing of measures modules. I train and direct the team for domain specific requirements and worked with developers to create prototypes and review with business users. I was also assisted the Business Development team in developing scope and capabilities in the clinical trial domainI advised in system compliancy for CFR21 regulations, CDISC (SDTM) standards and reviewed SOPs and CRFs.I was responsible for providing solution design and logical architecture for different neuro-cognitive and neuro-motor clinical trial data management software and defining algorithms and statistical and mathematical calculations for different measure modules such as subject mapping, response randomization, stimuli sequencing etc.

I was involved in managing Enterprise solutions for hospitals that connects different client data systems such as EMR and EHR and the implementation of HIPAA policies.I acted as FDA mock auditor for various medical software project and looked after the review and approval for regulatory dossier and documents.

I assisted in projects which were associated with the investigational drugs of oncology segment. I was involved in the processing of data from phase I, II and III of clinical trials and generating TLG’s according to the specifications. I was also involved in developing and management of regulatory submission documents to FDA and other controlling agencies.

As part of my PhD program criteria I taught graduate (MS) and undergraduate (BS) level Pharmacodynamics, Pharmacovigilance, Bioinformatics, Genetics and Molecular Cell Biology course in the University of Tennessee.My responsibilities included making and grading of quizzes, projects, and exams, group reviews etc., managing the laboratory resources, assisting in GTA weekly meetings and seminars, conducting various student projects and advising for Master’s and Bachelor’s dissertation

Each cell communicates with another cell or environment by a process called signal transduction. This is the key for many pathways of expression of life.The signaling in cell occurs by the help of surface signal receptor proteins. GPCRs are one of such proteins. GPCRs work in “lock and key” relation with specific ligand molecules. Those ligands bind to specific facets of GPCRs and this binding creates structural changes in the GPCR protein which initiates arrays of different pathways inside the cell. One of these pathways results in pancreatic cancer. We have taken human pancreatic cell lines and modified the GPCRs structure by introducing nanobots that bound to specific portions of the protein and changed structure of the latter. These structural changes resulted in decreasing the cell proliferative effect which proved the anti-cancer activity of this nanobots.

I was involved in the extraction and analysis of clinical trials data, generation of graphs, listings, and reports that supported the statistical and medical writing.

I was involved in managing the requirements and design implementation for one of the earliest CMS based business-to-consumer (B2C), e-commerce application (DreamHobbys) in India. I was responsible for analyzing existing business, pain areas, and areas of improvement and proposed solution design.I provided functional decomposition of requirements, interface analysis, functional and non-functional requirement review and analysis at various interfaces of project development, documenting requirement risks, analyzing challenges and risks in eliciting requirements.I analyzed business rules by assessing the client, modeling data, analyzing decisions, analyzing document as well as created organizational models, scope models and mind maps.My responsibilities include designing risk strategies and creating risk responses, developing domain specific use cases, business rules, class models and conducting quality assurance testing of measures modules, assisting in generation of test plan and conducted UAT.I trained and directed the team for domain specific knowledge areas.