Summary

• Over 8 EIGHT Plus years of experience with experience working within top global and national Pharmaceutical companies like Pfizer, Novartis Consumer Health, GSK Consumer Health, Ranbaxy, Eli Lilly, UCB, Merck, Actavis, Celgene
• Adept at performing given tasks within the time constraints coupled with the ability to identify improvements and resolve work issues
• Provided demo to 30 clients.
• Provide response to RFP
• Define Architecture for in house and hosted system.
• Define integration strategies between any publishing systems with EDMS systems.
• Conducted business process, administration, and technical training to clients while also accomplishing more than 10 projects as a project manager.
• Excellent Business writing skills in writing Business requirements document, User requirement Specifications, Functional Specifications, Systems Design Specification SDS
• Thorough exposure of conducting sessions and interviews with Subject Matter Experts SME and data stewards to understand the business process, business rules, and data requirements.
• Worked in complete project life cycle of Analysis, Design, Implementation, Integration Testing, and Functional testing.
• Involved in User Acceptance Testing and training of end users.
• Experience of creating applications that are 21CFR Part 11 compliant.
• Experience in coordinating and managing onsite and offshore development team, testing team.
• Good understanding of FDA ,EMEA, Canada, Japan, Gulf Countries , Paper and NeeS submission Information Technology Architecture

Technical skills

Professional Experience

Confidential

Senior Implementation Engineer, Technical Lead

Responsibilities:

• Employ installation of software packages at the customer site while following the regulatory system development procedure as well as analyze the system's requirement and plan.
• Define architecture on local and global bases.
• Create integration architecture for information system.
• Depending on the business and technology requirements create interoperability between systems.
• Work with business, IT and Vendors to come up with new revised architecture for development, Validation and Production environment.
• Transfer US, EU, JP, CA, CH submissions to eCTD tool, ensuring maintenance and integrity of data through SQL script and manual testing.
• Collaborate with customer's business and technical personnel to track necessities to a technical tactic and modify scripts according to specifications while studying its requirements.
• Guarantee completeness, accuracy, and validation of files through the use of software development lifecycle. Gather and assess requirements in collaboration with pharmaceutical clients and render timely resolutions to secure client satisfaction.
• Managed Onshore and Offshore team to create and deploy prequalified images for development, UAT and production environments.
• Confer with IT and Validation teams in getting qualified system to be accessible for in-house implementation of SaaS projects.
• Team up with clients and the Recombinant Team to determine scope, time and source estimates, schedule, and costs. Identify system deficits and provide responsive business outcomes to client's needs while verifying process workflows and technical qualifications.
• Supervise overall phases of project business plan as well as complete budget estimations. Ensure overall success of project completion and communicate with the project team members/staff and stakeholders.
• Utilize strong technical, analytical problem solving and presentation skills and broad knowledge of several IT fields and matters.
• Track business issues during project life cycle in time and provide bug number to clients as required
• Carry out implementation, validation and business procedure workshop as well as trainings through site-to-site visitation approve documentation validation when needed in a project.
• Analyzed existing Business units, Business process, System/ Application and there Interfaces with their capability through one to one interview with SMEs, open-ended discussions, brainstorming sessions, and prototyping
• Mainly assisted with documenting processes, used Validation methodology to write the Descriptive User requirements and designed Functional specifications.
• Served as a liaison between the internal/external business community and the IT organization in order to provide technical solutions to meet user needs.
• Worked with Associates and understood the business rules, systems and integrated them into the requirements document.
• Created workflows, context diagrams, and other industry standard documents to represent client's business processes.
• Analyze case report forms CRF data using extensive knowledge of phase I, II and III clinical trial studies.
• Conducted Risk Analysis to identify the risks associated with developing the application
• Responsible for creating maintaining Requirement Traceability Matrix in order to track the process.
• Provide response to Request for Proposals RFP from clients for new business opportunities
• Draft Statements of Work SOW , including defining the scope and approach, for client engagements
• Provide software demonstrations on the software solutions group products eCTDXPress, ISIPublisher, VLM, ISIToolBox, FirstDoc and CRFTrack
• Work with the sales specialists and professional services team to develop implementation, Validation and delivery models for solutions
• Provide feedback to the product development team on product enhancements from the sales cycle

Career Highlights:

• Provide Demo on Publishing Products to Pharmaceutical clients
• Work with Account Manager and Sales Specialist to close deal
• Work with client IT and Business team to finalize the architecture before the project startup.
• Displayed adeptness in 21 CFR Part 11 guidelines and GAMP4/5. Attended to client's needs regarding electronic and paper submissions US, EU, AU, CH and JP .
• Have Validated 20 project following validation IQ/OQ/PQ protocol
• Conducted business process, administration, and technical training to clients while also accomplishing more than 10 projects as a project manager.
• Traveled and closed projects in over 10 states and 2 countries, providing contribution to business team responsible for more than 12M in software and service sales yearly.
• Generated statement of work SOW and proposals to be submitted and approved by stakeholders author request for proposals RFP for clients and provide resolutions to their needs.
• Thorough knowledge on implementing publishing products on SaaS system and on Premise system.

Environment: MS Visio, MS Word, Case Complete, Snagit, SharePoint, Documentum, Windows 2003/2008, Oracle/SQL.

Confidential

Technical Lead

Responsibilities:

• Wrote master validation plans, user requirement specifications URS , functional requirement specifications FRS , system design specifications SDS , master test plan, master validation plan, validation protocols IQ/OQ/PQ , Data Migration script, traceability matrix and summary of reports in compliance with GxP.
• Analyzed existing Business units, Business process, System/ Application and there Interfaces with their capability through open-ended discussions, brainstorming sessions, and prototyping
• Mainly assisted with documenting processes, used agile methodology to write the Business Requirements documents and designed Functional specifications.
• Served as a liaison between the internal/external business community and the IT organization in order to provide technical solutions to meet user needs
• Participated in design review meetings and translated the requirements to the developers and guided the team when issues related to business requirements arose.
• Worked with Associates and understood the business rules, systems and integrated them into the requirements document and assisted in generation of test cases and test data.
• Created workflows, data diagrams, and other industry standard documents to represent client's business processes.
• Conducted JAD sessions between the business users, Developers, testers Subject Matter Experts to resolve bottlenecks.
• Conducted Risk Analysis to identify the risks associated with developing the patches, and formulated a Mitigation Plan to eliminate or reduce risks of high severity and any major effects.
• Played an active role in the UAT
• Responsible for creating maintaining Requirement Traceability Matrix in order to track the development and QA process.
• Interacted closely with QA to finalize the Test strategies and maintained quality assurance using HP Quality Center.
• Provided production support pre prod and post Prod issue management and defect tracking.
• Assumed full responsibility in the implementation, product support, system architecture, data migration and validation of information acquired.
• Performed data migration through the use of eCTDXPress import functionality and SQL script. Studied and approved validation of data.
• Sustained important data and documents with update in the support knowledge base with solutions, status, and implementation records.
• Generated SOP's for services department investigated, analyzed and resolved deficiencies linked with the project and participated in the company's software products improvement with main focus on system architecture and packaging. Examined plans and SOWs and provided support for new clients identified business opportunities with existing clients
• Drafted, reviewed and approved Data migration plan ,Implementation plan, Validation plan for projects

Career Highlights:

• Acted as the main technical consultant all throughout the project life cycle. Provided recommendations for changes and improvements of environments while developing and employing IQ OQ PQ protocols, UAT plans, and summary reports.
• Distinguished improvements to develop processes and enlarge efficiency and productivity. Defined business process together with the clients in accordance with the agency guidelines FDA and EMEA produced business roadmap and released all IQ OQ PQ on time.

Confidential

Technical Lead

Responsibilities:

• Compiled Vision and Scope documents to better define the rationale for the project.
• Updated the Functional Requirement Specifications FRS based on User Requirement Specification URS .
• Gathered and articulated business requirements from users and SME interviews and maintained the document repository on Requisite Pro.
• Good knowledge of clinical trial development processes- eCRF, CDISC, SDTM, ODM, Safety, Regulatory Compliance
• Used guidelines and artifacts of RUP to strategize the implementation of Rational Unified Process effort in different iterations and phases of software development life cycle SDLC .
• Assisted with/facilitated mapping of to-be processes and worked on the gaps of as-is to to-be processes
• Recommended revised and/or improved business processes for the new SDMMIS implementation.
• Collaborated with the customer to develop acceptance test criteria.
• Wrote requirements for the designing data marts that were used as the source for the various reporting systems in the company.
• Performed testing on a data warehouse platform, including data integrity and data validation.
• Performed Data Analysis and Data validation by writing Sql queries using TOAD.
• Worked with the DBA and developers to identify bottleneck and performance issues of the ODS population and work together to resolve the issues.
• Knowledge of RDBMS concepts and exposure to various databases systems like Oracle and MS SQL Server
• Collaborated with the project team to achieve customer and team objectives.
• Constructed eCTDs including new drug applications for US regions and generated test bed to implement complete operational requirement of newly deployed software documents.
• Produced electronic and hard copies of several documents, such as SOPs, work instructions, forms, logs, templates, and flow charts of products. Managed change control files, tracking of deviations, and investigations and various documents when needed.
• Transferred all FDA submissions into eCTDXPress tool complying with 21CFR Part 11 and GAMP4 guideline. Reinforced handling of master documents according to approved processes: conducted training for business consumer on merchandise functionalities.
• Developed tracking databases, as required and uploaded final and approved documents into electronic document share site, Livelink 9.5. Assisted with electronic document management implementation as well as training and program management maintenance.
• Assumed full responsibility in supporting the quality functions in the eCTDXPress and ISIPublisher presentation. Ensured adherence to internal procedures in handling document control to QA R D for daily work priorities. Supported the Regulatory Affairs applications.

Environment: SOA, SQL Server 2008, MS-Office, MS Visio, RUP.