Akramuddin Syed ***************@*****.*** 510-***-****
Professional Summary:
8+ years of extensive experience as a Business Analyst- Lead with strong experience in Pharmaceuticals Domains with a solid understanding of Business Process Flows, and Business Analysis. Detail-oriented and good documentation and process management skills.
Strong understanding of GxP quality guidelines: Good Manufacturing Practice, Good Laboratory Practice (GLP), Good clinical Practice (GCP), Good Distribution Practice (GDP), and Good Regulatory Practice (GRP).
Extensive experience in Business Analyst, in Pharmaceutical, Life Science and Health Care Software Validation and business process re-engineering with proven ability to articulate business values.
Experience in Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies.
Experienced in building and maintaining web applications using Adobes AEM CMS to include site architecture, custom components, workflow development, Digital Asset Management (DAM)
Analyzed user behavior and customer journeys using Adobe Analytics, providing actionable insights that improved conversion rates.
Collaborated with marketing teams to define and track custom success events, segments, and eVars for in-depth campaign performance analysis.
Conducted A/B testing and funnel analysis, identifying bottlenecks that led to improvement in drop-off rates.
Defined and executed personalization strategies using Adobe Target, increasing user engagement.
Worked closely with marketing and development teams to implement experience targeting (XT) and recommendations.
Integrated Adobe Target with Adobe Analytics (A4T) for deeper insights into experiment performance and customer behavior.
Led the implementation of Adobe Experience Platform (AEP) to create a unified customer profile, enhancing personalization efforts.
Collaborated with data engineering teams to ensure smooth data ingestion from multiple sources into AEP.
Enabled real-time customer segmentation using Adobe Customer Journey Analytics (CJA) for targeted marketing campaigns.
Exposed to diverse business processes, that includes Pharmaceutical and Healthcare.
Experienced in building and maintaining web applications using Adobes AEM 5.6, AEM 6.0, 6.1, 6.2 and 6.3 to include site architecture, custom components, workflow development.
Good experience in Tableau Dashboard implementation and management.
Experience as Salesforce.com Business Analyst in Business Requirements Analysis Requirement Gathering and Gap Analysis
Experience in working on Veeva vault which is a content management system over the cloud.
Extensive knowledge of compliance to FDA 21CFR Par t11, 50, 56, 58, 210, 211, 312, 314.80, 820.
Industry specific expertise includes life sciences (GMP &GxP systems), aerospace, discrete manufacturing, financial services, insurance, government, legal and medical equipment.
Experience in Adobe Experience Manager [AEM] for building and managing websites and leveraging web content management components for customization and porting of websites, AEM - Digital Asset Management, Workflows, Websites, Tagging, User Management.
Experience in developing new business initiatives, business analysis, strategy development, regulatory approvals for marketing, new market access to international business partners.
Having knowledge in Veeva Vault and its integration with Veeva CRM in order to facilitate Veeva CRM Multichannel functionality (CLM, Approved Email).
Developed visualization reports using DOMO as an alternative to Tableau.
Different software development environments including Agile-SCRUM and Waterfall models.
Strong Business Analysis Skills including in-depth knowledge of Software Development Life Cycle (SDLC), having thorough understanding of various phases like Requirements, Analysis/Design, Development and Testing.
Extensive knowledge of Salesforce.com implementation cycle in Sales, Marketing, Service and support modules.
Experience in business acumen, stakeholder engagement, relationship management, and strategic planning.
Good handson experience in ConformiQ tool for Test Design Automation (MBT).
Experience in Veeva integration on Salesforce/Force.com Platform, building Veeva Vault workflows.
Experience in writing SQL queries and optimizing the queries in Sybase, Oracle and SQL Server.
Experience in creating custom site templates and list templates for developing web part pages for the portal using SharePoint Portal Server.
Adobe Experience Manager (AEM) testing, UML, Use Case, Visio Flows.
Understands medical coding and assists in reviewing the validity and completeness of data within CTMS as needed.
Experience in Tableau reports development and support.
Knowledge of Laboratory Information Management Systems (LIMS).
Participated in UAT (User Acceptance Testing) with all levels of User Groups. Experience in working with QA team to develop the Test plans, Test scenarios, Test procedures, and Test cases to ensure adequate testing of software both before and after completion.
Assured Process Validation, Cleaning Validation, and Software Validation in compliance with cGXPs (cGMP, GLP).
Strong understanding of information technology capabilities and dependencies, including platforms, content management, e-document strategies and process mapping.
Strong knowledge of the Software Development Life Cycle methodologies (phases and gates) like Agile and Waterfall mode
Technical Skills:
Methodologies
OOAD, RUP, UML, SDLC, JAD, Six Sigma, CMM, RAD, SCRUM, ETL
Languages
C, C++, Java, C#, XML, SQL, UNIX
Computer system Validation
21 CFR Part 11, 210, 820, GxPcGMP, GCP, GLP, SOPs, GAMP, Summary Reports, Audit
trails, Validation protocols IQ, OQ, PQ, SOP's, VMP's, RTM, LIMS, AERS, Audit trails, SDMS, IEC 1497, ISO 13485, 14971, Quality Improvement tools GR R . QMS.
Operating Systems
Window NT/95/98/2000/XP/Vista, Unix
Change Management Tools
Rational Clear Quest, Test Director
Business Modeling
Tools
Rational Rose, Rational SODA, Requisite Pro, Clear Case, Clear Quest, Microsoft Visio
Project Management
MS Office Suite, MS Project, MS Visio
Databases
MS SQL server, MS Access, Oracle 11i, RDBMS Concepts, Database Development,
Version Control Systems
Rational Clear Case, PVCS
Web Technologies
ASP, HTML, XML, Adobe Photoshop, Adobe Light room, Dreamweaver, Flash
Technical Writing
Validation Master Plan VMP, Functional Specification FS, Design Documents DS, Test Plans, Requirement Traceability Matrix RTM, Test Cases, Text Summaries, GxP Compliance Report Generation, Software Generation, IQ, OQ, PQ, DQ.
Testing Tools
Rational Test Manager, Mercury Test Director, Win Runner, Load Runner, Rational Robot
Education:
Masters of science in Computer Science from Silicon Valley University, San Jose, CA. (2017)
Bachelor’s in civil engineering from JNTU University, India – Hyderabad (2014)
Professional Experience:
Velocity Data Solutions (Client - Innowi, Santa Clara CA). April 2024 - present.
Lead Business System Analyst
Responsiblities:
Lead end-to-end requirements gathering sessions through interviews, document analysis, surveys, and workflow assessments, ensuring alignment with stakeholder needs.
Develop comprehensive requirements specification documents, user interface guides, business process workflows, and functional/ technical documentation.
Identify opportunities for process optimization, redesign business methodologies, and introduce innovative solutions to meet long-term strategic objectives.
Conduct needs assessments, impact analyses, and organizational readiness evaluations to enhance program and system efficiency.
Design and develop interactive dashboards
and reports using Tableau and Power Bl, providing real-time business intelligence and performance insights.
Extract, clean, and transform data from SQL Server and Oracle databases for analytical reporting.
Implement calculated fields, parameters, and LOD expressions in Tableau for advanced data visualization.
Integrate Power Bl with Azure DevOps to track sprint velocity, burndown charts, and team performance metrics.
Manage small to medium-scale projects, ensuring timely and cost-effective delivery.
Collaborate closely with development
teams throughout the project lifecycle, facilitating UAT testing sessions with stakeholders.
Prepare and deliver executive-level project
updates, highlighting key milestones, challenges, and solutions.
Environment: MS Access, Outlook, Waterfall, Agile, Adobe Photoshop, Kneat, Servicenow, SQL, Jira, Confluence, Sharepoint and other MS Office tools.
Indegene (Client - Abbvie), Chicago, IL BSA Delivery Lead – AEM/.NET/SITECORE Jan 2022- to-Jan 2024
Responsibilities:
worked with cross functional teams in transition projects with competitor vendors.
worked with cross functional teams for gathering requirements, execution of gathered requirements, and also worked with top tier management to provide my sense of understanding on implementation of planned projects.
Worked on platform migration project from Site-core to AEM where we migrated 300+ sites from Sitecore to AEM and I was a part of this execution in terms of Lead Business Analyst role.
Worked with different execution teams and involved with planning, testing and development of site migration projects.
Worked on migration SLC documentation, Decommission SLC documentation.
Worked with new BSA’s in team to train them and get them upto speed in understanding broad process of SLC documentation.
worked with Adobe Team and Business to identify the gaps in the requirement and fine tune the requirements so that they fit in web platform’s framework.
Worked on SLC documentation Process to identify the risks and defects by collaborating with DAST.
Worked on Service-Now for ticketing purposes and reviewing knowledge base.
Used different Teams and Smartsheet channels to communicate project status within the Abbvie team.
Used Jira/Smartsheet/Confluence as a Project Management tool for project planning, roadmap and dev. Team alignment on the requirements.
worked with cross functional teams, brand teams and clients to see if requirements are properly met.
worked to improve the current Processes and workflows within the AEM.
Communicate with Dev team for appropriate delivery of the enhancements/requirements.
worked on Content Management platforms
Understanding of templates, components, and authoring requirements in a CMS
Worked on demonstrating newly design sites/functional updates to the testing teams.
Worked on creating Test cases for user testing referring the FRD’s in KNEAT.
Environment: MS Access, GxP, Adobe Experience Manager (AEM), Outlook, Veeva CRM, Veeva Vault, Waterfall, Agile, Adobe Photoshop, Kneat, Servicenow and other MS Office tools
UPM Pharmaceuticals, Bristol,TN October 2021 – Dec 2022 Sr. Business Analyst- AEM
Portal Systems – Adobe Experience Manager (AEM) – EDW – EMR Systems Implementation
UPM Pharmaceuticals is a Bristol, Tennessee-based independent contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries. UPM provides high quality pharmaceutical drug development services that include formulation development, AEM, cGMP manufacturing and packaging, analytical method development and testing from concept through commercialization. The system majorly maintained a record of all the accounts and respective contacts and opportunity details of the UPMS clients. The system had an extended functionality of maintaining a close eye on the clients with more than 5K opportunity amount.
Responsibilities:
Conducted meeting with Clinical, Biotech and Pharma experts for gathering current requirements and future goals.
Responsible for reviewing and approving glass syringe product transfer activities from R&D to Commercial Operations.
Responsible for gathering business requirements into Adobe Experience Manager (AEM) functional components.
Responsible for gathering business requirements into Adobe Experience Manager (AEM) functional components for online query experience.
Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
Modified and developed new reports and a few dashboards using Tableau tool with enhanced visualization of the data.
Key support for data entry and maintenance for hospital application " Echo"
Extensively involved in every phase of the RUP process starting from Inception to Transition
Implementation and maintenance requirements of Conformiq products tackle the challenges of traditional test automation and enable your organization to test.
Worked on Veeva CRM application support.
Created quotes on the Salesforce platform with CPQ software for client requirement.
Interacted with users for verifying User Requirements, managing Change Control Process, updating existing Documentation.
Working to gather Requirements for migrating of Content from Portal to Adobe AEM and functionalities including multi-site management and multi-channel management and Digital Asset Management.
Management of patient profile transfer (PPT) reports created by data team by verifying the associated data.
Developed Tableau visualizations and dashboards using Tableau Desktop.
Captured enhancements for Veeva Events Management, including Veeva CRM and Veeva Vault.
Designed and implemented basic SQL queries for reports and data validation.
Installed and configured version 6.3 of Adobe AEM Web Content Management System.
Create new privilege forms for providers of all departments for newly acquired hospitals using Echo.
Participated as a core team member of a Clinical Development initiative to create an architectural business end-to-end solution for clinical trials as a standard for all remote data capturing clinical trials.
Responsible for Reviews, edits and formats all GxP Audit reports.
Worked on Veeva CRM Functionalities, Salesforce and has knowledge of Veeva Vault.
Participates in User Acceptance testing of new enhancements to the Salesforce platform.
Provide support for Manufacturing/ Quality Systems like Laboratory Information Management System (LIMS) and Open Array Manufacturing Order Processor.
Conformiq products fit the needs of Agile software development by adapting quickly to new product requirements.
Worked with life science organizations to analyse their current infrastructure and provide suggestions for new ways to bring efficiency.
Implemented Salesforce/Veeva CRM application.
Responsible for gathering business requirements into Adobe Experience Manager (AEM) functional components for new online shopping experience.
Created action filters, parameters, and calculated sets for preparing dashboards and worksheets in Tableau.
Performed User Acceptance Testing (UAT) for various web based and database related applications.
Worked on implementing continuous improvements to the Quality Systems required to execute and implement current good manufacturing practices (cGMPs) related to the manufacturing of finished medical devices.
Maintain revised and updated privilege forms in Echo for multiple facilities.
Developed custom templates, components, and widgets using AEM and integrated Components.
Tests and analyzes samples for GxP, or Research.
Design, develop and implement solutions for the Salesforce/Apttus CPQ/CLM system deployed on the Salesforce platform.
Provisioned in SFDC and Veeva CRM applications.
Performed requirements modeling and developed analysis diagrams, activity diagrams, sequence diagrams, state diagrams, data models, and use-case realizations using RUP tools in Agile/Scrum.
Created custom reports and enhanced Salesforce.com environment as per user needs using Apex and Visualforce Pages.
Responsible for managing and enhancing multiple instances of Veeva Vault.
Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance.
Experience with data visualization tools Tableau and Qlikview and power BI
Gathered requirements and designed an inventory control system for the R&D labs, for chemical and biologics, integrated into the ELN/ electronic lab notebook project having many EHS/Environmental Health and Safety implications.
Used AEM tool for designing the checkout components and for better management of the data.
Created and documented Salesforce application requirements by working with end users and key stakeholders.
Installed and configured version 6.3 of Adobe AEM Web Content Management System.
Defined charter, scope, schedule, and resources for projects productizing R&D programs, managing (and often defining and delivering) customer needs via marketing requirement documents (MRD) and product requirement documents (PRD) with program milestones, user documentation and QA, increasing profitability while building a best practices organization.
Analyzing requirements and implementing solutions to build the tool in AEM.
Find and update correct NPI numbers for providers in Echo that do not have NPI on record.
Performed VEEVA CRM compliance business rules testing.
Prepared UAT Materials, including the UAT Process, UAT Test document which would include step-by step process for UAT as well as all the tests that would cover all requirements.
Wrote FDA21 CFR compliant test plans, test scripts and completed executions of IQ/OQ/PQ.
Worked with Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards to capture, store, preserve and deliver content and documents related to organizational processes with Every Document Now Available (EDNA).
Environment: MS Access, MS Visio, SQL, GxP, Adobe Experience Manager (AEM) 6.4, Outlook, Veeva CRM, Veeva Vault, Waterfall, GMP/GDP/QMS 21 CFR:820, Agile, Adobe Photoshop and other MS Office tool
Alexion Pharmaceuticals inc., Boston MA April 2020 – September 2021 Sr. Business Analyst- AEM
Patient Portal – Adobe Experience Manager (AEM) & Scheduling Systems
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. I worked on requirements gathering, analysis, design and implementation.
Responsibilities:
Proven ability to apply best practices, work in the Salesforce governor limits and devise innovative solutions to meet project's requirements.
Partner with Compliance and Legal leadership to understand business capability needs and priorities; partner with other Alexion IT functions as well as external vendors to identify next-generation solutions.
Working on change management with end-users related to new capabilities being developed or on-going changes to the Salesforce platform.
Performed under Regulatory Compliance (GxP, FDA/GLP).
Responsible for using AEM tool for better management, documentation, and delivery.
Used AEM tool for designing the checkout components and for better management of the data.
Work with Echo business team to learn any new task assigned to me in Echo application.
Expertise in Veeva Vault configuration, presently working as Veeva Vault consultant to end-to-end product and then implementing in the environment.
Developed Tableau workbooks from multiple data sources using Data Blending.
Lead and own business architecture by articulating business strategy and gaining IT alignment to business capability demand.
Identify process improvement opportunities and propose implementation of advanced features to drive additional business benefits from existing solutions and investments.
Work with the development team to configure Veeva as per requirements.
Involved in integration of Salesforce/ Apttus CPQ/CLM with third-party domain using web services.
Partner with Enterprise Architecture to develop detailed, integrated Compliance and Legal systems roadmaps covering the entire data Lifecyle from data capture to data reporting and data retirement.
Worked as Salesforce.com CRM and Veeva CRM that includes Administration, Configuration, Implementation, Development and Support activities.
Thorough knowledge of ECHO reporter functionality
Developed simple to complex visualization reports using Tableau as well as DOMO.
Oversight and execution of a risk based GXP Supplier and Partner management program including Pharma covigilance and IT software / software as a service (SaaS) provider.
Utilize Adobe Experience Manager (AEM) to analyze and resolve issues reported by end users.
Act as an end-to-end service broker to the Compliance and Legal teams for the entire systems development life cycle (SDLC) - from business case development to solution selection to project delivery to benefit realization and system support.
Accountable for business-facing activities such as demand management, business case development, requirements management and user acceptance testing (UAT); partner with other IT functions for all aspects of technical delivery such as build, code and unit/ system integration testing.
Managed and supported Salesforce integrated applications related to field services, licensing and customer support.
Simplified asset management approval process by integrating Veeva PromoMats with CRM.
Leads the design of database queries, and reports on the HEDIS measures, QST, ECHO & Quality Metrics suite of reports.
Responsible for Trouble shooting and debugging any kind of issues in AEM environments.
Worked on various Veeva Modules like - Accounts, Order Management, Sample Management, Inventory, Calls, Engage Meeting, CLM, Consent Capture, Approved Email, Marketing Event, Call Objectives, Survey, Territory Assignment, Coaching Reports etc.
Design solutions using custom or existing systems in partnership with Compliance and Legal to meet the needs of the Compliance and Legal community, with partners like commercial, medical, and others as required.
Conduct thorough analysis of the current system and schematics and provide upgrade assessment to AEM 6.0.
Provide IT leadership and guidance while communicating IT vision and strategy across all levels effectively.
Multi-year road-mapping, budget forecasting (Capex/Opex) and budget management
Managed Approved E-mail content development and integration into Veeva CRM.
Validated end-to-end data analytics echo system. Employee objective & development planning, performance & compensation assessments, career.
Coordinate with Project Manager, Business, Developer, team and function as team player.
Report Defect during Testing cycles and Analyze defects by determine their severity and reproduce rate.
Involved in Tableau Administration to schedule reports and assign rights to the users to view the reports.
Work in partnership with core AE's to provide expert CPQ knowledge and support to Grow business
Creation of process flow for SFDC in to CPQ, Service Cloud to OMS
Manage, and execute on Salesforce configuration projects of varying complexity to ensure the smooth operation of our day-to-day function.
Utilize Adobe Experience Manager (AEM) to analyze and resolve issues reported by end users.
Help in Development POC for various modules of Veeva.
Logistics price calculator application in Salesforce using Visualforce, JavaScript & Apex
Team management and work assignments for cases in SFDC
Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
Wrote SQL queries using MS Access for data manipulations.
Worked on Veeva CRM Functionalities, Salesforce and has knowledge of Veeva Vault.
Be supported by marketing, outbound lead generation team and entire echo-system, including field sales and pre-sales consultants.
Worked on Software Development Life Cycle (SDLC) process in the areas of Analysis, Design, Implementation and Testing of Software Applications using Java/J2EE technologies.
Create custom workflows using AEM 5.6.
Creation and maintenance of reports to support the business in Salesforce.
Key resource to capture, analyze, review & document compliance & ad hoc requests requirements.
Track and communicate test results and issues encountered with Developers.
Creation of Opportunities and Cases in SFDC and following the same for resolution.
Managed system upgrades, enhancements, and maintenance in a cGMP environment
Close Defect after fixes and by re-testing it in third part Reporting Tool called Paragon.
Leading team to map requirements, writing test scripts, performs as QA review and gives related guidance to write and execute test scripts using Quality Center.
Validating the data that arrives from different data sources and generating the reports in Salesforce.com for the next day’s Lead assignment.
Created action filters, parameters, and calculated sets for preparing dashboards and worksheets in Tableau.
Reviewed training materials for accuracy related to Salesforce CPQ functionality.
Worked on Apttus CPQ configuration and integration.
Implemented and customized Salesforce customer relationship management (CRM) for Marketing, Sales and Case Management also implemented sales cloud and service cloud to improve customer retention and service delivery process improvement.
Created test cases and test plan for Echo-CIS Interface process and also executed all test cases using manual and automated tools.
Used Adobe Dynamic Tag Management (DTM) and integration of AEM with Adobe Analytics and Adobe Target.
Make the system available in Salesforce 1 Mobile and lightning to adopts new features in Salesforce and retire from old like Enterprise Territory Management2.0 and Collaborative Forecasting etc
Reviewed and developed the Standard Operating Procedures (SOP’s) for the different functionalities and areas of compliance and doing risk management.
Configuring and creating SAML packages for AEM service provider.
Execute of system test scripts for both a web application & content management system.
Authored Test Summary Reports and Trace Matrix.
Designed and Developed Test automation Strategy for Quick Test Pro and Quality Center.
Configured Shared Object repository and used SQL/PLSQL Oracle products for query management.
Identifies and gathers requirements and builds out solutions to address issues within Salesforce CPQ.
Daily update on Sales Force (SFDC) about the activities every day.
Developed custom Apex classes for Visual force page custom controllers using Salesforce.com, IDE and Apex Enhancement.
Environment: MS Office, DCTM WebTop, eRoom, HP Quality Center, Veeva CRM, Veeva Vault Sales Cloud, Salesforce CPQ, Apttus, HP QTP, LIMS SQL*LIMS, DQL, TOAD, AEM 5.6/ 6.0, Apttus X-Author GxPharma, Arbortext, XML, HTML, Oracle, SQL, MS-Project, Windows 2000.
Actavis Parsippany, NJ April 2018 – March 2020
Business Analyst Pharmaceutical
Inventory Management Systems & Enterprise Data warehouse Projects - Pharma.
Inventory Management System was built using visual basic.NET as the front end and SQLServer 2000 as the backend. All the applications were designed and tested according to 21CFR and FDA rules. I was also involved in Verification and Validation (V&V) engineer on a Blood Sugar Test Meter for diabetes patients. The device was to be used along with Lilly’s drug delivery device. The data captured by the meter will be eventually migrated to the Desktop computer via docking station. This application was used to monitor the blood sugar levels of the patients. Interface application software was developed to manage Blood Sugar readings for patients.
Responsibilities:
Planning, preparation and submission of dossiers for NDA and BLAs and variations (labelling review, new indication, change of manufacturer and/or primary packaging site and/or release site, change in primary packaging material, shelf-life extension, change of specification limits, etc.)
Prepared and published post-approval supplements, amendments such as PAS, Annual reports, CBE-O, CBE-30s.
Coordinated with project manager to write the Validation Master Plan (VMP)
Handle daily maintenance tasks associated with Salesforce.com
Wrote the Installation Qualification (IQ) & Operational Qualification (OQ) Test Plan
Performing tasks of Batching, Scanning, Indexing, Importing, Searching, Rework and generate excel reports.
Coordinating the various departments and functional areas for the progress of study documentation, package creation and data entry activities.
Used TIBCO and Informatica for doing ETL operations as required.
Worked in SCRUM/AGILE and acted as SCRUM MASTER to conduct daily operations.
Team player in project management for meeting the deadlines and support with clinical study reports.
Conduct sponsor study startup process, set-up of trial master file (TMF), site selection and assist management of vendor contracts, budget and RFP/vendor proposal process.
Worked on various Salesforce.com standard objects.
Implementation, migration, custom development, and validation of Oracle-based Laboratory Information Management System (LIMS) using SQL* LIMS.
Involved in defining, documenting, and execution of the overall OQ process including the base LIMS and additional customized portions of LIMS
Coordinated with System analyst and Network administrator to make the server and machines qualify through complete Installation Qualification (IQ) and Operational Qualification (OQ) procedures
Involved in developing local level Standard Operating Procedures (SOP’S) for hardware and software maintenance, user account policies
Preparation of documentation for Archival, in accordance with company SOPs and industry standards.
Review and approve vendor responses to quality assurance audits for appropriateness,