Project Management

Pranav Garg, MS, MBA

**** ****** ******, ******* ** 93458

407-***-**** *******@*******.***.***

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OBJECTIVE

Utilizing 5 years of Healthcare and Business development experience to help the clients to analyze current operational procedures, identify problems and handle the specific requirements driving corporate strategy towards competitive advantage. Possessing excellent communication and professional skills while working in both structured as well as unstructured environment. I am a Self Starter and Quick Learner with Excellent Verbal and Written Communication skills.

CORE COMPETENCIES

Organizational and Strategic Planning CRM Experience Detail Oriented

Project Management (PM) Cross Matrix Team Management Presentation Skills

BUSINESS ANALYTICAL SKILLS

o Project Management (PM) Experience within the Pharmaceutical Industry.

o 3+ Years of experience with Clinical Trials in a CRO.

o Conducted clinical monitoring visits to facilitate pre-study, initiation, interim and close-out.

o CMC practices of Small Molecules by implementing strategy and serving as the regulatory representative between the Research Team and the relevant regulatory authorities along with coordinating various CMC aspects of regulatory submissions.

o Experience in documenting the business requirements acquired both from end users and stakeholders.

o Strong knowledge of ICD-10 and HL7

o Good understanding about GCP/ICH/FDA regulations and related industries, such as Pharmaceutical and medical industry.

o Extensive experience with analysis and review of Business and Functional Requirement Documents.

o Experience in general engineering and science principals and laboratory skills.

o Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements across Project Life Cycle.

o Experienced in Software, Algorithms, Chemical and Biochemical technologies as they pertain to the design, integration, evaluation and commercialization of diagnostic systems.

o Change management process including resourcing, scheduling and scope for the assigned project.

o Architectural and product knowledge of Documenting ECM platform, including Content Management, Records Management, and Business Processes of Management components.

o Experience in configuring and maintaining Defect Tracking system using mercury quality center (10.0 Version).

o Excellent communication skills with the ability to communicate with both business and development teams.

TECHNICAL EXPERTISE

Rational Tools Rational Rose, Clear Quest, Requisite Pro

Microsoft Tools MS Office Suite, MS Visio, MS Project

Databases MS SQL Server, MS Access, Oracle

Languages C, C++, SQL, Basic, VB, XML, Java EE

Methodologies RUP, SDLC, UML, Agile

Testing Tools Rational Test Manager, QTP, Mercury Quality Center

PROFESSIONAL EXPERIENCE

Orlando Regional Medical Center, FL (Sep 2011-April 2012) Medical Ed Analyst

Project Management (PM) in a Healthcare setting involves planning, organizing, securing, and managing resources to achieve specific goals and commercialization, which in my current Biologics project is to establish the ways of internal and extramural funding through ORMC's Educational Department. This project was aimed at creating collaboration between Orlando Health and Valencia College. The PM with my team was done through budgeting, creating smaller sub-research projects and workflow charts to specify business process supported by individual grants. Responsible for approval of FDA and international submissions, CDISC, filing, compliance and communications.

Experience with state advocacy plan along with development of both short term and long term advocacy programs. Assisted in coordinating efforts between patient advocacy, state, society and other like organizations to ensure quality patient care at the local level through ORMC setting. Knowledge of Federal and Florida state rules.

In order to simplify the project, WBS scheme was incorporated by successively subdividing it into manageable components in terms of size, duration, event, segment and responsibility, which include all steps necessary to achieve the objective. I started the PM with five process groups which included:

• Initiation: This is where I explained the basic objective of creating sources of Internal and Extramural Funding through various foundations in the State of Florida.

• Planning: Interacted with the scientists and corporate team in order to define the scope of funding and gather User Requirements and feasibility studies of these foundations. Subsequently upon conducting interviews with them and analyzing their current funding patterns I created Requirement Specification Documents which included expenses for Inventory, chemicals, fixtures and equipments, pre-paid expenses, transportation costs, building depreciation, salaries etc. For planning purpose I identified used cases and thoroughly studied them for Business Requirements.

• Execution: Using various online tools, I was able to formulate laboratory marketing (flyers and posters), which increased our visibility by 65% in the Central Florida market, managed financial data set which was effective in creation of budget for the grants, Healthcare Office Management for the development of research proposals, submission of accounting budget forms to ensure compliance with sponsors and organization-wide policies and procedures. Responsible for high quality sourcing deliverables - spend & cost analysis, bid analysis, evaluation scorecards, risk analysis, and sourcing recommendations.

• Monitoring: In collaboration with my Science Director, I was able to document a detailed report at the end of each testing phase. Additionally I created the Master Test Plan that defines the how this educational program will be a great asset to the organization and would generate roughly $50,000 for this relatively smaller department. Additionally conducted market-intelligence activities including supply market research, identification of trends and best practices.

• Closing: The project is still ongoing with other teams working on it.

Our project followed the ISO 10006:2003, for Quality management systems and guidelines for quality management in projects to deliver output to various internal and external customers.

UCF College of Business Administration, FL (Aug 2011-Present) Business Instructor

Developing several examination question datasets with focus on entrepreneurial track and business ethics using MS Excel and Blackboard Enterprise Vista 8 while being responsible for keeping the knowledge of UCF policy and guidelines. Design and implementation of statistical outcome of the results in the form of grade reports, graphical inference, assessment data analysis and assisting students with change and career development opportunities to think “out of the box”.

Life Sciences Business Unit, FL (Dec 2009-July 2011) Scientific Consultant

• Project Management (PM) principles applying a standardized and evolving set of project management principles as contained in NIH guidelines for testing and validation of BAX mutants through experiments for the provisional filing of Patent with the Office of Commercialization.

• Created Requirement Specification Documents (RSD) for cancer registry after interacting with the scientists and end users to analyze their current systems.

• Completed validation of JASCO Spectropolarimeter J-815 and Langmuir Blodgett Trough KN 0044 for new electronic documentation system.

• Performed experiments and feasibility studies to file Provisional Patent in the biotechnology industry with exposure to both development and commercial phases of product lifecycle (Pro-apoptotic peptide based drug).

• Participated in teams for relevant CMC drug development regulations and guidelines.

• Conducted the validation of HPLC Systems using cGMP guidelines, quality and regulatory assurance, developed and executed though pharmacy, institutional and formulary process.

• Automated paper-based quality system for Good Manufacturing practice Guidance for Active Pharmaceutical Ingredients.

• Involved in Validating Biological Systems using cGMP guidelines (analytical, quality, process development) developed and executed validation guidelines for testing the GMP, GCP and GLP sensitive experimentation.

• Created Patent Commercialization Requirements and converted them into Experimental System Requirement Specifications.

PepsiCo Summer Job, NY (May 2008-Aug 2008) Summer Analyst

Performed the experiments on food spoiling bacteria and assisted the scientist in conducting qualification tests at each stage of the process implementation, aggregate spend reporting, confirming that all components of new system were functioning to specifications and in compliance with NIH regulations. Communications reports using MS excel for business processes.

• Analyzed functional requirements and details design of the application and its interface.

• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, including: Validation Plan and Protocol, Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.

• Facilitated (JAD) Joint Application Development sessions to identify business rules and requirements and then documented them in a format that can be reviewed and understood by both business people and technical people.

• Created targeted Questionnaires for end users to gather requirements.

• Studied and analyzed competitor’s applications and brainstormed to gather effective requirements for a quality product.

• Tested the final application for Usability testing to verify whether all the User Requirements were catered to by the application.

• Involved in preparing a simple and detailed User manual for the application, for an intended novice user.

Education

BS in Biotechnology

MS in Biomedical Engineering

MBA in Management/Health Care

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