SUMMARY:

• 9+ years of professional experience as a Project Manager, Scrum Master and Release Manager along with Delivery Management in Pharma Regulatory Affairs and Confidential across Consumer, Pharma and Medical Devices sectors and IT industries (especially in Infrastructure and Application management services) with excellent understanding, analysing, and documenting Business and Project Requirements, Functional Specifications, Business Process Flow, ITIL operations and Business Process Mapping.
• Excellent Analytical skills to understand the business process and Functionality, Requirements and to translate them to system requirement specifications
• Excellent understanding of Pharma R&D, regulatory and Operations along with IT - SAP (ERP) and BI project implementations
• 9 years of team manager experience in assigning, directing work, appraising performance and guiding for professional development of the team.
• Rewarding and disciplining team along with issue resolution and problem-solving sessions. coaching and mentoring team for project planning, review, risk management & problem- solving approaches to ensure global alignment of work practices through adoption and use or business processes, technology tools and continuous improvements

SKILLS & ABILITIES:

• Project Management
• Leadership
• CLINICAL TrIALS MANAGEMENT
• SAP
• SPSS
• VENDOR MANAGEMENT
• AI / Machine Learning
• CMC, Labeling & Publishing
• Costing & Budgeting
• Pharmacovigilance & Drug Safety
• Risk Management
• Strategy Development
• Stakeholder ManageMent
• ITIL Operations
• MS Visio / Business Analysis

EXPERIENCE:

Project Leader

Confidential

Responsibilities:

• Leading AI / Machine Learning project for Global Translations within J&J and its subsidiaries especially for Labeling, PV and Drug Safety areas
• Define technology strategy for business partners Manage business expectations and keep business aligned to business requirements
• Understand competition and how they use technology
• Oversees internal and external collaborations
• Provide input to PLOs for future requirements, especially key business capabilities, and the associated value to the Product Line as an input to shape the product strategy

Investment manager

Confidential

Responsibilities:

• Defines priorities for business and associated technology investments
• Actively participate in steering major strategic IT programs to drive successful implementation and business value realization
• Accountable for all aspects of delivery
• Accountable for operational IT expense
• Review high level business case, budget forecast, budget tracking (baseline Vs actual) and financial metrics
• Understands core internal IT products and ability to drive business value
• Drives business partners towards standard solutions
• Coordinates with other BU BTLs
• Customer Focus & Management
• Direct collaboration with customers to enable and support strategic programs
• Continuous improvement of the IT operating model
• Business Process Improvement
• Identify process pain points and early improvement opportunities
• Build business case for improvement initiatives (e.g., impact, feasibility, and investment required)
• Create implementation plans for improvement initiatives including timeline, owner, and key milestones along with IT service offering through designing and implementing a Service Catalogue following ITIL principles

ProGRAM Manager

Confidential

Responsibilities:

• Responsible for one of the in-house performance management application development, enhancements and deployments working as Release and Deployment Manager along with ITIL operations with IT service catalogue development detailing Level I and Level II activities through service now platform.
• Managing project around systems, data architecture and IT security
• Responsible for multiple projects simultaneously. These will be projects involving the update or replacement of server technologies for a variety of business and / or technical support systems
• Working collaboratively with all participants in software development project and is supportive of developers and testers as they set up their build dev/test environments
• Building the IT Release Calendar in working closely with the IT release Coordinators from different portfolios across IT and centralizing view of all releases
• Assisting in managing projects and interdependencies to ensure milestone adherence to ensure the integrity of the release can be measured
• Managing risks and resolving issues that affect release scope, schedule and quality
• Measuring and monitoring progress to ensure application releases are delivered on time and within budget, and that they meet or exceed expectations
• Coordinating release content and effort based on the service request backlog, pending service requests, third party applications, or operating system updates
• Communicating all key project plans, commitments, and changes including requirements, QA plans, schedule, and scope changes and other release details and to the Business as required
• Managing relationships and coordinating work between different teams at different locations
• Producing Deployment, Run Books, Implementation Plans and Release Reporting
• Negotiating, planning and managing all release activities
• Working with project teams to understand impacts of branches and code merges
• Leading and coordinating Go - Live activities including the execution of the deployment Plans and checklists
• Participating in release meetings to discuss release scope and/or roadblocks
• Maintaining a release repository and manages key information such as build and release procedures, dependencies, and notification lists

PROJECT MANAGER

Confidential

Responsibilities:

• Responsible for the development, deployment and management of the Project Management Office supporting both internal development and client-based Medical and Regulatory affairs solutions, methodologies, training and project support.
• Managing a portfolio of clinical and regulatory projects, ensuring coordination of shared resources, common activities, and other dependencies across projects
• Developing and managing program financials including forecasting, profitability, invoicing and expense management
• Responsible for the successful planning, implementation and execution of assigned clinical projects
• Actively provide guidance & review of the scope of work, objectives, timelines, quality of deliverables, and other clinical projects
• Oversee & manage clinical project development to ensure data quality and integrity
• Assigning, and directing work; appraising performance & guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
• Coach and mentor employees around project planning, project review, risk management and problem-solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees
• Identifies unusual or significant risks encountered during a clinical project and proposes strategies for preventing or correcting them
• Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps Working with individual staff to identify any quality issues within the study and coaching on the resolution of issues, including implementation of corrective action plans and escalation
• Collaborate with other management and leadership team members to proactively identify the project and or individual needs and resourcing solutions to manage study issues and obstacles
• Work with the client & Senior Management to ensure that project budget(s) meet financial and company goals (targets), with a focus on proactively ensuring adherence to change control processes
• Facilitate hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans
• Review and assess project profitability through the identification of “out of Scope” activity in a timely manner and supporting continuous process improvements
• Worked on 510K submission for one of our clients for their medical devices

Confidential

PROJECT MANAGER

Responsibilities:

• Responsible for planning and directing deployment of third party’s Pharmacovigilance (PV) Case Processing and Reporting services which will impact stakeholders across different PV functions and country sites
• Provide formalized, continuing work direction and leadership to assigned teams of Subject Matter Experts (SMEs) and PMO project staff including scheduling, assignment, and review of project work. Responsible for appropriateness, applicability and quality of each aspect of project
• Develop workable plans with key stakeholders to both meet Drug Safety PV business needs and deadlines as well as manage cross-functional relationships
• Identify compliance and quality risks to PV that can occur during project implementation phase and immediately after, and lead risk management planning
• Work with Drug Safety PV management to escalate and resolve outstanding issues to keep teams and project productive
• Provide consulting for solutions specific to issues that arise from PV outsourcing, PV database migration, and harmonization of both
• Outline areas of PV process improvement, transformation, and efficiency planning to increase overall productivity
• Manage project scope and requirements along with contract and account commitments, avoiding unexpected or unnoticed scope-creep
• Utilize PMO Framework when collaborating with team
• Determine the resources (time, money, equipment, etc.) required to complete the project and ensure that all projects are delivered on-time, within scope and within budget
• Determine success criteria with which the project will be evaluated at completion
• Review project schedule with senior management and all associates affected by project activities
• Coordinate internal resources (including business stakeholders and business system administrators) and third parties/vendors for the flawless execution of projects
• Establish a communication plan to update project stakeholders on the progress, changes or escalation of the project and project plan
• Mentor CLIENT associates in project management methodologies and practices
• Significant accomplishments:
• To improve project management services, built an operational PMO from the ground up in 8 months and deployed a Project Management Methodology based on the principals and best practices of the Project Management Institute. Optimized efficiency by 60% and resulted in an increase of sales by around $4 million within 12 months.
• Provided quality oversight on 18 project teams producing 100% on time performance to promise date and budget resulting in $5 million of additional business.

PM Consultant

Confidential

Responsibilities:

• Lead one of the Pharma Regulatory project operations and different activities including
• Regulatory product lifecycle maintenance activities of product renewals, variation filing, PSUR submission through liaising with different internal and external stakeholders to ensure quality submission readiness by the time
• Provide project-specific regulatory technical expertise & co-ordination oversight for key client’s projects along with directing other GRAs assigned to support projects of responsibility
• Collaborate extensively with people throughout the company, with clients & with regulatory authorities
• Assist in identifying & recognizing out of scope activities in a contract in a timely manner & liaise with line manager to follow all aspects of contract modification including project budgeting, forecasting & risk management
• Selection & onboarding process of new candidates through profile review and Interview process
• Develop training plan and strategy for the project team with the collaboration of HR
• Ensuring team have enough resources, training and materials to do their job

PROJECT LEAD

Confidential

Responsibilities:

• During testing phase of programming created procedures and documentation on 115 tasks related to process flows. This dual process ensured that all tasks where able to be performed with customized program and the staff has documentation to perform the tasks effectively. Each task included: Overview, Responsible Parties, Frequency, Reports, Retention, Procedures, and Oversight like that of a IT service catalogue.
• Facilitated professional training with 35 employees on all tasks assigned to their role. Every task was assigned to a primary, secondary and oversight person trained and capable to perform tasks as needed. Training was performed in multifunctional groups, departments and individual as needed for successful implementation. By supplying suitable documentation and training was able to effectively complete transformation into new ERP system.
• By working with programmers, managers and accounting the team converted old system data into new system. Being the primary point of contact ensuring that all parties were working together on a common goal was paramount in the success of the implementation.
• Developed ERP security protocol for all departments and positions to ensure control on all processes both in staging and real - environments.
• Successfully completed pilot project with Zero-defect and 99.99% right first time and implemented business analysis tool for Confidential customers and accounted for accuracy increase by 25%.

Confidential

Team Manager

Responsibilities:

• Responsible for leading a Sales team & Operations team, developed and delivered the company’s business strategy along with part of budgeting in a specified business unit through project management techniques and principles.
• Ensured that existing and new customer relationships are strengthened to continue growth, and to achieve revenue and profit targets.
• Conceptualized and managed employee engagement process and initiatives.
• Provided independent oversight of various risks to the top management on day-to-day basis.
• Complaints handling & Review Branch Operations reports.
• Branch Merchandising & co-ordination with Marketing at product level.
• Served as Confidential for Customer Care Measure (CCM) and managed the score to reach all-time high during my tenure.
• Acted as a POC for ERP integration and system maintenance within the area.
• Analysed the attrition reasons by using Fish Bone methodology and suggesting recommendations to improve the retention rate.
• Acted as a liaison between business owners and project teams.