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Work Background
MIT Sloan School of ManagementAI/ML Implementation in Pharma and Biotech Industry Research
Feb. 2024Artificial Intelligence and Machine Learning (AI/ML) will play a vital role in R&D in coming years, especially in Clinical Trials, Drug Discovery, pharmacovigilance, Market Research and Supply Chain. Generative AI is expected to produce $60 - $100 billion in annual value across the pharmaceutical industry value chain (source: McKinsey analysis). 50% of the global healthcare companies will implement AI strategies by 2025 (source: USM Systems). Participating in a certification course at MIT to further the research on AI opportunities in biotech and pharma industries.
Wiz Thru LLCCo-Founder of WizThru
May. 2020 - Dec. 2021New Jersey, United States · RemoteWizThru was designed with social impact in mind to encourage proper social distancing in today's COVID 19 environment. WizThru Solution enables consumers to book an appointment slot with a business, thus eliminating the need for lines and ensuring social distancing. WizThru is a free service designed to help businesses stay open safely and avoid requiring another shut down during fall/winter. For more information, please visit: www.wizthru.com
BiogenProject Manager – Global Regulatory Planning, Global Regulatory Information & Operations
Jan. 2017 - Jan. 2024A new strategic approach to Global Regulatory planning, submissions and reporting was developed to help Global Regulatory leads with their activities and resource planning. Monthly Global Regulatory Reports helped the GRLs in improved resource forecasting 3-5 years out, with detailed breakdown of Agency Meetings, Submissions and Approvals at Monthly/Quarterly level. My responsibilities included: Support Submitted & Marketed and Early Late Stage Products
Leads, Labeling and Publishing teams to update their respective product details. 25+ individual MS Project files were created and maintained to track Global Regulatory Activities for each of the Products MAA Filing PMO Support
• Developed standard templates to support MAA filings (Global)
• Developed Detailed filing plan ~5k lines in MS Project (POL) to track detail tasks for all core dossiers (Mod 1-5), Medical Writers, Bio Stats, publishing and regulatory planning. Work with Global team to capture all details.
• Help negotiate timelines between teams to bring timelines within the filing deadlines
• Incorporate tasks for parallel filings in other countries
• Provide PMO support to the Global Lead(s) Accelerated Registration & Launch Opportunity for Intercontienental Markets
• Working with regional VPs and Senior Executrive Directors to study current product registration processes and develop new strategies to accelerate the filing process by 6-12 months for top 12 intercontinental markets.
• Six Sigma processes were used to develop SIPOCs to analyse and identify gaps in current processes and to develop new engagement/filing strategies
Shura Consulting Group, LLCDigital Development Project Manager
Aug. 2016 - Dec. 2016Develop digital strategy and mobile application for not for profit and political organization. • Requirements gathering, development and launch of a Mobile Application developed (off-shore) for iPhones and Android. • Architect, design and development of the web portals and Internet/Intranet sites
• Developed Social Media strategy, launch and marketing plans
NovartisSenior Project Manager
Oct. 2015 - Jul. 2016As part of a new Global, cross-divisional initiative, Novartis launched a System Transformation Initiative for Development Excellence. Global Programing and Statistics Environment Replacement
This replaced the outdated GPS environment by implementing a state-of-the-art cross-divisional IT solution to analyze and report clinical data for health authority submissions. • Developed the initial project charter and the Capital Appropriation Request (CAR) for the planning phase. • Managed monthly financial forecasts in Clarity and generated monthly reports against actuals in SAP
• Aligned the project plan with high level Program milestones set by the Program PMO
• Developed reports and for presentation to the Steering committee
• Developed the CAR for the Execution Phase Digital Development - eSource Integration
Digital Development program aims to transform the way clinical trials are conducted by leveraging latest technologies. The Digital Development Program addresses the many issues of clinical trials such as site burdens, participant definitions, low retention, high monitoring and management costs, poor data quality and reporting, data Quality Control and regulatory compliance. The main objective of the eSource Integration project was to reduce the time spent by Investigation sites in a clinical studies transcribing in paper records. The integration was designed for smooth transition of data between Oracle Clinical and SureSource (a mobile tablet application). • Transitioned over from a FTE PM during the final phase of Phase I deployment due to delays and challenges within the core team (located in NJ, Basel and India) • Managed the UAT/PQ formal testing and all Go Live activities. Conducted daily 7:30 AM EST calls to bring the project timelines back on schedule, completed Phase I two weeks ahead of schedule.
• Conducted a full day Phase II kick off workshop with all stake holders and vendors, consolidated high level requirements for phase II
QSAFTSenior Management Consultant
Apr. 2015 - Sep. 2015Assisted a team of senior industry leaders in launch of a new Strategy Development & Implementation Company, specializing in process, project and program management for pharmaceutical and financial industries. Key focus of this firm is in the Mobile application development for business process improvements. • Assisted in the development of execution/implementation strategy for mobile development, testing and training
• Identified key off shore resources and partners (vendors) for the mobile application development
• Utilizing my past contacts and off shore relationships, helped in the setup of an offshore model for development and testing of mobile applications, including on-boarding of right resources • Setup processes for day to day work/management of offshore teams, including reporting schedules.
Roche/SSI StrategyPV System Inspection Readiness Initiative
Oct. 2014 - Mar. 2015Basel Area, SwitzerlandMarket Research and Patient Support Programs (MAPS)
• Developed a detailed project plan to implement a standardized process for the quality management and monitoring of MAPs globally with 90+ affiliates/countries. • Developed a detailed communication plan for all communications with Affiliates and stakeholders
• Traveled regularly to Switzerland, Germany and England for meetings and to provide support to affiliates and Global MAP team
• Developed a retrospective Non-Interventional Program (NIP) data clean-up process and execution plan.
• Developed processes for: NIP data review and data verification, evidence review, MRP data sampling, affiliate documentation of deviations and final attestation of data clean-up. • Developed a User Guide for NIP Retrospective Data Review Tool – NRDR
• Provided day to day operational support for Risk Area Owners (RAO) such as decision making, approach discussions, process development, etc.
• Pro-actively identify risks, define & implement mitigation actions to improve the PV inspection readiness
• Developed and presented a by-weekly Status metrics at the Global Sponsor’s and Steering Committee’s meetings
Zoetis / DeloitteSAP ERP - Order to Cash PM/PMO
Jan. 2014 - Sep. 2014New JerseySAP ERP-O2C PM/PMO
Pfizer’s animal health division was spun off as a new company in February 2013. As one of its first major initiatives, the new firm decided to deploy its own global SAP ERP system. A select European and Asian markets were picked for the pilot deployment with target go live in fall 2014. The overall SAP program is divided into multiple towers. As the project manager and member of the O2C PMO for Order to Cash, my responsibilities included:
- Working closely with the Program PMO - Developed detailed micro step plan for Order to Cash and all its sub processes.
- Billing, A/R, Credit and Rebates
- Master Data and Pricing
- Global Trade Services (GTS)
- Global available to promise (G-ATP) • Worked closely with each of the sub process’s IBM lead, business technology lead and the client's GSPO • Developed a detailed test execution plan (ITC-1, ITC-2, & UAT) with the IBM O2C lead, including SME travel planning and budget approvals
• Participated in bi-weekly micro step planning calls with markets in Belgium and Singapore
• Worked closely with training team to track the development of SOPs, BPPs, Concept slides and Quick Reference guides
• Developed plans to begin localization for Phase two deployment, targeted for Spring 2015
• Designed a template for sub processes to use during the weekly core team meeting. The template helped the teams track WRICEF development status, TUT, FUT, ITC-1 script executions
• Hosted the weekly core team status meeting
• Ran bi-weekly reports in Solution Manager to track progress of WRICEFs, TUTs, FUTs, and training materials
Shura Consulting GroupImplementation Research Analyst (Unique Device Identification UDI & GUDID)
Jul. 2013 - Dec. 2013In September of 2013, FDA released the Final Rule on the Unique Device Identification. This was an Amendment to FDA’s 2007 Act (FDAAA). Based on the new UDI rule, estimated deadlines have been identified. My responsibility as a research analyst included:
• Review and understanding of the UDI rule and its implementation deadlines
• FDA’s requirement for the submission of the Device Identifier (DI) attributes
• Manufacturer’s responsibility to maintain the Product Identifier (PI) information
• Global Trade Item Number (GTIN) Allocation Rules (defining when UDI becomes a requirement)
• Defining Device Identifiers and packaging hierarchies
• Understanding the UDI attribute management o Data Source identification and cleansing o Management of attribute revisions and GTIN synchronization o Data extracts and submission to FDA (GUDID uploads and integration to UDI)
• Review and understand current device serializations processes and recommend updates to the processes to accommodate the new rule
• Identify technical solution(s)for the implementation of the new rule
• Managing CFR Part 11 and other regulatory requirements to ensure proper System and Data validations are in place. • Help client develop an implementation strategy, program/project plan development, identification of in house and consulting staff, Project Charters and budgets
www.Alerts2u,comDeployment Manager
Jul. 2013 - Dec. 2013New JerseyManaged the production deployment of a Mobile Communication Tool for Schools, Teachers, athletic teams and coaches. My responsibilities included:
• Confirm final results from all beta testing of the product
• Coordinate and manage cut over and production deployment activities
• Communicate downtime to customers
• Received Facebook approval for user authentication using Facebook login • Develop, dry run and ensure the roll back plan is in place for execution, if needed
• Coordinate and confirm readiness from all partners for Go Live • Work with large customers (500+ users) to coordinate mass registration process and production support
• Managed and conducted knowledge transfer from the developers(contractors) to Alerts2u employees based off shore
Merck & Co. IncSr. Project Manager/PMO
Oct. 2010 - Jul. 2013Global Safety Integration Project Manager - GSIP (October 2010 – Present)
The Global Safety Integration Program (GSIP) is a major Merck initiative charged with worldwide integration of Global Safety systems and processes. Global Safety operates in 80 countries, processes approximately 250,000 cases annually and supports audits and inspections when they occur.
Merck & Co. IncGSIP Project Manager for Signal Management, Metrics and Reporting
Oct. 2010 - Sep. 2012(October 2010 – September 2012)The GSIP program includes fifteen individual streams. My responsibly was to lead three of these fifteen streams, Signal management, Metrics and Reporting. • Got formally trained in Blue Print for requirement and design documentation
• Worked with each of the three IT Business leads to develop detailed project plans for the requirements phase.
• Managed all aspects of the program related to these three streams, including resource management
• Developed and presented weekly status reports to the PMO during a weekly Program meeting
• Monitored and tracked the time of all resources on the three streams
Merck & Co. Inc.Sr. Project Manager for Merck's Compounds' Divestiture
Apr. 2010 - Mar. 2011The United States Federal Trade Commission (“FTC”) required the divestiture of the NK-1 Compounds in connection with the Merck merger with Schering Plough. I worked with legacy Schering Plough team (Clinical Research & Programming, Clinical data management, GRA, Discovery, PhamSci, Pharmacovigiliance, Regulatory and Quality), Intellectual Property, legal department, Out licensing department, Global Occupational & Environmental Toxicology and the third party to ensure proper knowledge and material transfer. -Developed process for transferring data via a secure file transfer (SFT) services utilizing Axway servers -Developed a separate process for transferring physical inventory and physical data such as hard paper documents, lab equipment, chemicals, radioactive material etc.
-Enhance the NK-1 Transfer application/database design which generated a transmittal form listing details on material being transferred. This transmittal form was signed by Merck Business units and an acknowledgement signature was also obtained from the third party on completion of the transfer. -Managed a complete end-to-end test of the SFT process to confirm acknowledgements from both Merck and the third party.
-Traveled to Miami with senior Merck Directors to finalize the acceptance of all material transfer by the third party. Conducted a formal four day audit & training at the third party's site of all materials transferred, reviewed electronic and paper catalog systems and processes to locate items, answered all clinical/research related questions and concerns by engaging Merck's subject matter experts in multiple teleconferences. -Assisted Accenture's senior partner to develop an In/Out Licensing playbook for Merck compounds for divestiture or acquisition of a product. The Playbook was developed to document the processes and enablers developed while capturing recommended practices for future use based on this project's success. -Completed the project nine months ahead of schedule
Unit Trust Corporation –TTUTC (November 2009 – April 2010)Program Manager for Upgrade of Card Management System
Nov. 2009 - Apr. 2010A Trinidad and Tobago bank had realized the need to upgrade their current backend core banking system to rapidly respond and adapt to their dynamic business needs, concurrently providing a middleware infrastructure with the ability to integrate the current Card Management system and all future new business related systems.
Schering Plough /Merck & Co. IncDeployment Manager: Siebel CRM based Clinical Trail Management System Deployment (CTMS)
Jun. 2009 - Dec. 2009Global Clinical Trail Management System Deployment (CTMS) - Upgrade of a 12 year old CTMS with a new Siebel CRM based System (SPECTRUM).
I was the deployment manager responsible for the roll out of the new CTMS application to 80+ countries and close to 3000 users. The overall budget for the project exceeded $28 million. Responsibilities as the global deployment manager included:
Coordinating all deployment activities with development, Integration, Implementation, Migration, UAT and Training leads
Developed a detailed roll out plan for four different wave deployments. The four waves were identified by the business based on study protocols and their respective countries.
Coordinated with the data migration teams to make sure they had all the local studies defined by country. Coordinated with business to confirm the Go Live user list for each wave. Worked with infrastructure and desktop engineering teams to conduct desktop assessments in order to confirm software and hardware compliance.
Coordinated the user account creations with Siebel administrators and the training to make sure only users who completed the training were getting their users accounts activated (comply with 21 CFR requirements)
Coordinated the development & testing of two Radia packages for deployment. Thin client included the Active X control and the URL icon and the fat client which included the full remote Siebel client with a local database.
Developed and implemented a process to manage and maintain consistency of over 1600 LOVs across seven different environments.
Developed and implemented the user provisioning process for new users in SPECTRUM and during the interim migration of four waves.
Developed and implemented Operational Support Plan (16x5). Identified Level I, Level II and Level III support individuals and conducted appropriate training.
Developed and implemented the Go Live Help Desk process.
EisaiProject Manager
Sep. 2007 - May. 2009Senior Project Manager
I was the lead project manager for both the ARISg and SRA Business Objects deployment. I managed a team of 20+ individuals which includes business users, IT managers, and their respective staffs working on two separate projects. ARISg Ugrade:
Originally, the business users in North America and UK/EU were using two separate ARISg 3.x client server applications with two separate databases. This project merged the separate databases into one consolidated database, housed in North America. We also upgrade the database from Oracle 9i to Oracle 10g. The application was also upgraded from ARISg 3.x to ARISg 5.x. The ARISg 5.x is a web based application and is being deployed using Citrix across all sites (US, UK, EU, Japan and other Far East partners). The most complicated aspect of this deployment was the data cleanup process which required code list cleanup and normalization, database merge and upgrade. Safety Reporting Application (SRA) Upgrade & Re-validation: (Business Objects & Crystal Reports)
The business users use Business Objects to generate reports for internal use and external reporting to the health authorities. The reports have been designed using Business Objects and Crystal Reports. Original Universe and the joins were validated against the ARISg 3.x database and all reports were qualified. After the Go Live of ARISg 5.x, a new universe and joins pointing to ARISg 5.x were validated and all reports were re-qualified.
Dun & Bradstreet IncSenior Project Manager
Apr. 2007 - Oct. 2007I was the lead project manager for both the ARISg and SRA Business Objects deployment. I managed a team of 20+ individuals which includes business users, IT managers, and their respective staffs working on two separate projects. ARISg Ugrade:
Originally, the business users in North America and UK/EU were using two separate ARISg 3.x client server applications with two separate databases. This project merged the separate databases into one consolidated database, housed in North America. We also upgrade the database from Oracle 9i to Oracle 10g. The application was also upgraded from ARISg 3.x to ARISg 5.x. The ARISg 5.x is a web based application and is being deployed using Citrix across all sites (US, UK, EU, Japan and other Far East partners). Safety Reporting Application (SRA) Upgrade & Re-validation: (Business Objects & Crystal Reports)
The business users use Business Objects to generate reports for internal use and external reporting to the health authorities. The reports have been designed using Business Objects and Crystal Reports. Original Universe and the joins were validated against the ARISg 3.x database and all reports were qualified. Some of the key responsibilities included:
Developed Project Charters
Organized and hosted project kick off meetings with key stake holders and members of the steering committee from across all sites. All project kick of meetings were held; Developed detailed project plans, managed resources and budget
Reported quarterly to senior executive managers and the steering committee on both the capital projects. Executive management was based out of Japan.
Managed day to day activities, issue resolutions, resolve personality conflicts, conducted weekly project status meetings which were driven by the project plan and a Milestone Dashboard document.
Dun & BradstreetSenior Project Manager
Oct. 2006 - Apr. 2007I was the lead project manager for two of D&B's most critical upgrades, Alert Services hardware upgrade and Enterprise Monitoring applications' reengineering. Alert Services and the Enterprise Monitoring application are D&B's cash cows. Both of the projects were out sourced and were managed by vendor's project managers, reporting to me. I worked with a team of 25+ individuals and was responsible for approving time sheets for 8 of the consultants. The application reengineering project was out sourced to Cognizant Technology Solutions (CTS). Majority of the development and testing teams were physically located in India and 4 consultants were on site.
The hardware refresh project was out sourced to Computer Science Corporation (CSC) located; The Sybase DBAs, mainframe team, UNIX team, and the data security team were all located in Berkeley Heights and other CSC locations. Acted as a liaison between the two vendors to coordinate and negotiate all activities related to the Go Live. Conducted weekly status meeting with each vendor individually and than a combined weekly status with the entire team, including project leads from both vendors.
Worked closely with business and participated in weekly status meetings. Acted as a liaison between the business and the D&B Information Technology team.; Infrastructure project - NT 4 End of Life Manufacturing Device PC-Remediation RFC development for capital approval
Schering PloughResource Management
Mar. 2006 - Oct. 2006As part of the PMO team, I was requested to manage vacation/personal times for the period of June 2006 - October 2006 for all project team members (60+ contractors/SP employees, Oracle consultants). The PMO office implemented a vacation freeze for the months of August 2006 & September 2006. Clarity application was used for project planning, estimating, budgeting, resource allocations, collaborations and time capture. Validated GPV CARES under Citrix v.6.3 for the Clinical Department (1 week in June 2006)
Due to personality conflicts between the IT lead and the Clinical manager, this task was not progressing. The steering committee decided to provide each Clinical user of GPV CARES with two machines on their desks, one ruing Citrix 6.3 for their clinical applications and the other machine running Citrix 8.2 for GPV CARES. I did not see this as a viable solution thus I negotiated and convinced senior management and steering committee to allow this validation test
Developed a strategy for validating GPV CARES to run on the Clinical desktops running Citrix version 6.3
Negotiated with Schering Plough's Validation Unit to conduct this validation testing in the UAT environment.
With the help of IT technical leads, GIT Quality team and SVU leads, identified 15 Functional Verification testing scripts to use as the Citrix v 6.3 validation scripts
Successfully validated GPV CARES to run under Citrix v 6.3. This eliminated the need for the Clinical desktop users to have two desktops on their desks. Taking this initiative built a lot of good will and team sprit between the GIT and clinical business lead. Environment Analysis
Schering PloughGIT Project Manager
Feb. 2006 - Oct. 2006In February 2006, I transferred the deployment responsibilities to a Schering Plough senior manager and started working with the PMO team. Mckinsey group was instructed to focus on the organizational and business process restructuring while I took over the overall management of the IT Project and the fourteen project leads. My responsibilities as part of the PMO team member included:
Developing and maintaining a comprehensive IT project plan in MS Project, utilizing Project Server. Each of the fourteen project leads were asked to developed a detailed project plan. Integrated all fourteen plans into one Master MS Project Plan
Developed and maintained a GIT Milestone Status Document (metrics) which was presented every week by each stream lead to the PMO team in a weekly team meeting. These milestones were taken directly from their individual project plans.
Conducted bi-weekly meetings with all leads before the PMO status meeting to make sure they were on track as per their respective plans. Integrated and developed the metric slides to include the Project Milestone Status from the business leads and the Mckinsey team members. Worked closely with all leads to help eliminate gaps. Helped business and the Mckinsey team members to develop detailed MS Project plans for business activities for Go Live, which was later also integrated into the overall master project plan.
I was responsible for preparing the presentations for the PMO Status meetings, captured all action items during the PMO meeting and followed up on the action items during the week with respective team leads. E2B Qualitative Testing Project Management
Shura Consulting GroupManaging Director
Jan. 2006
Schering PloughProgram Manager
Dec. 2005 - Oct. 2006Due to the NT end of live, the infrastructure group was tasked to remediate all machines that were still running Windows NT and were connected to manufacturing devices. I was hired as a program manager to conduct global analysis and recommendations for the development of the RFC. Met with business owners to discuss and negotiate devices that will not be upgraded under this RFC. Many devices were removed from the scope of this project based on several criteria developed by the project steering committee. The final list was reduced to around to 180 devices from the original number of 800, globally. This reduction alone saved Schering Plough over $15 million. 13 of the 180 devices identified were validated, GxP systems.
Met with vendors to negotiate equipment purchase, delivery, transportation, staging, PC build, custom application installs, testing, validation and user training (Dell & Perkin Elmer).
Developed the final presentation for the RFC approval.; Global Pharmacovigilance -Corporate Adverse Event Reporting and Evaluation System (Oracle AERS/GPV-CARES)
Schering PloughDeployment Project Manager
Dec. 2005 - Jan. 2006I was part of a team of fourteen project leads, all reporting to the PMO team headed by the Mckinsey group and a GIT director. GPV CARES, a validated adverse event reporting system was deployed to 89 countries. I served in this role for approximately six weeks, after which I was asked to join the PMO team. My responsibilities as the deployment project lead included:
Developing and maintaining the deployment project plan in MS project Identifying and defining the final application deployment list for category 1, category 2 and category 3 countries and respective users/user roles with help of business users
Worked closely with other project leads to integrate their respective plans and timelines related to deployment Functional Verification Testing Support Manager During the 10 day vacation period of the functional verification testing lead, I was requested to also lead the functional testing. Responsibilities included:
Managed the functional verification testing team of 16 testers
Managed all day to day activities of FV testing
Assigned test scripts to individual testers based on their skill level and competency
Produced daily status metrics for the PMO office
Off Shore Software Development Co.Medical & Insurance Information Portal
Feb. 2004 - Nov. 2005Managed the design & development of a Public Internet portal for a start-up company.
Gathered all user and business requirements and developed the design documentation
Developed estimated budget for the complete SDLC Managed the relationship between the client and the off shore development team. Developed prototype of the database and the proposed front end module in MS Access. The prototype was demonstrated to the marketing team to get their feedback on user interface and ad placement & management. The portal was developed using Java scripts, EJB, and Java servlets on a Tomcat 4 Server.
Off Shore Software Development CompanyAccounts/Project Manager
Jul. 2001 - Nov. 2005Worked as an accounts/project manager for an off-shore company, managing off shore projects of their clients
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