SUMMARY

• Over 10 years of certified Project Management Professional wif results oriented, excellent analytical, facilitation and strategic planning skills in large scale enterprise - wide diverse industrialsectors.
• Managed cross functional teams wifin matrix environments in simple to complex organizations through effective relationships.
• Worked in project/program environment from conceptual stage to project close-out - Initiated, planned, executed/controlled, and closed projects to scope, quality, budget and schedule requirements while effectively managing changes to meet stakeholders’ expectations.
• Proactively established and managed internal stakeholder and leadership relationships to ensure alignment for outcomes, managing expectations, driving alignment and managing issues as necessary.
• Defined Critical Success Factors (CSFs). Brought about agreement on the project goals wif management, project sponsors, and other stakeholders.Developed clearly defined plans wif assigned responsibilities and accountabilities, managed the project scope effectively and ensured management support through effective engagement.
• Facilitated work breakdown structure (WBS) sessions wif cross-functional teams and built WBS wif all dependences.
• Identified and managed risks associated wif successful project delivery such as areas of conflict that could present concerns vi a vi safety, quality, cost or time over-runs
• Conductedreviews/negotiations of vendor proposals, large contracts, product/services implementation, integration, ensuring on time delivery and project progress towards the goals through efficient and reliable metrics and documentation
• Experienced in conducting JAD (Joint Application Development) sessions, requirements workshops, brainstorming sessions, and requirements ralkthroughs for review and approval
• Facilitated gate reviews, coordinated wif multi-disciplines ensuring compliance wif job specifications.
• Prepared Work Packages, Invitation to Bid (ITB), technical bid evaluation, negotiation and performance evaluation of contractors in coordination wif disciplines, and As-Built documentation.
• Analyzed look-ahead schedules and executed as per plan. Ensured sound planning wif focus on envisioning problems and took necessary proactive measures.
• Reviewed reports supervised and monitored progress for project deliverables.
• Conducted team meetings, weekly collaboration/review meetings on project work activities to ensure support of project milestones, coordinated wif field personnel to formulate mitigation and recovery strategies.
• Strong ability to express business and projects’ goals to colleagues and management and communicate proactively at all levels of the organization.
• Planned and executed cost savings strategies: Resource optimization; Contract procurement strategy; Value Engineering etc.
• Carried out Management of Change (MOC): Resolved site issues by arranging design changes and obtained approvals, prepared trends for the capture of design changes; prepared change orders.
• Actively engaged in noledge sharing through seminars, collection, validation & implementation of lessons learned, best practices.
• Adopted partner initiatives and other systemic improvements incorporating intelligent, proactive value-adding approaches/work practices that avoid rework.
• Mentored junior employees and other technical staff in effective project delivery - compliance wif project plans and procedures, applicable standards, quality excellence, managing time efficiently and saving company resources.
• Resolved conflicts successfully for win-win outcomes built and sustained team environments among project stakeholders.

PROFESSIONAL EXPERIENCE

Regulatory Affairs Project Manager

Confidential, San Jose, CA

Responsibilities:

• Facilitated product development and global registration through the efficient preparation, management, and tracking of regulatory documentation and systems.
• Provided strategic guidance to partnering business lines to drive excellence in the design, implementation, and delivery of high-quality global regulatory submissions wifin required timeframes.
• Served as the primary point of contact for the project and/or submission teams when significant planning effort and oversight was required.
• Managed the compilation and publishing of key regulatory submissions for US and Europe and the emerging markets for clinical trials and aligned wif marketing applications.
• Developed strategies for submissions to FDA and other regulatory agencies. Provided regulatory risk assessments and options to product development teams.
• Prepared FDA submissions necessary for new product approval/clearance and product continuance:
• 510(k) Premarket Device Notification
• Pre-market Approval Applications (PMAs) of Devices and Supplements
• Investigational Device Exemptions (IDE) submissions

Confidential

Program Manager

Responsibilities:

• Formulated, organized and monitored inter-connected projects through computer simulation studies, bench scale testing, pilot testing and final deployment.
• Decided on suitable strategies and objectives and coordinated cross-project activities for optimal program performance aimed at maximizing Return on Investment (ROI) and regulatory compliance.
• Applied change management, risk management and resource management.
• Resolve projects’ higher scope issues, adopting Agile approaches.

Confidential

Project Manager/Sr. Project Engineer

Responsibilities:

• Prepared economic justification for projects,developed design basis and scope of work.
• Implemented project management procedures established in the business area, prepared project execution documents and reports.
• Defined the scope of work to be provided to potential contractors in RFP and performed technical bid evaluations.
• Developed project related documents such as project charter, scope of work, AFE, communication plan, HSE plan, quality plan, procurement plan, schedule & cost estimates, risk plan, etc.
• Coordinated wif discipline resources in developing project deliverables.
• Responded to contractor’s RFIs, concerns/questions on queries and procedures.
• Coordinated wif the contractors to ensure compliance to applicable safety requirements and procedures.
• For Tax Credit Claims on projects, examined reports & projects’ documentation, providing relevant input & write-up.
• Disseminated regulatory and societal implication of projects’/program information to project stakeholders.
• Conducted coordination and alignment meetings wif project stakeholders.

Confidential

Project Manager/Sr. Project Engineer

Responsibilities:

• Provided project management services, coordinated overall planning & scheduling, in creation of project manhours estimation and budgets, and monitored project progress milestones and cost performance.
• Coordinated preparation and delivery of project deliverables including design documents, EWPs, CWPs & bid packages.
• Coordinated wif Supply Chain Management, Vendors, Disciplines and Client including through MRs, POs for timely delivery of products and services.
• Conducted weekly & monthly progress meetings, resolved day to day issues and prepared reports as per agreed project procedures.
• Implemented effective Change Management: Trends, Engineering Change Notifications and Change Orders ensuring the required input from project disciplines.
• Arranged and participated in HAZOP meetings and 3D Model review sessions and coordinated implementation of recommendations.

Confidential

ASPEN SAGD Development

Responsibilities:

• Worked wif client in defining the scope and developing project plans and estimates.
• Provided necessary project management support to disciplines in facilitating generation of project deliverables (IFR, IFD & IFA) and cold eye gate reviews.
• Conducted project meetings wif discipline leads and clients for coordination in keeping the project on track.
• Led project team Project Execution Plans (PEP), Invitation to Bid (ITB) packages, Work breakdown structure (WBS), Environment Health & Safety (EH&S) Plan consistent wif regulatory compliances and As-Built documentation.
• Reviewed look-ahead schedules and executed assigned work portion as per plans, in support of project milestones.
• Reviewed reports, supervised and monitored progress for project engineering deliverables from EPC contractors, managed cross-functional discipline teams to approved scope, schedule, quality and budget.
• Prepared Class V cost estimate (+/- 40%) for overall annual budget approval and Class II (+/- 10%) cost estimation for each project to receive AFE.
• Participated in the annual budget planning for funds approvals to achieve company’s medium/long-term business plan.
• Coordinated technical review of contractors’ base design, detailed design packages, material submittals, shop/fabrication & vendor drawings, technical specifications, field change notifications (FCNs), technical queries (TQs) etc.
• Participated and Implemented Hazard Operability (HAZOP) recommendations on projects.
• Established and monitored project KPI’s and developed plans to meet them.
• Reviewed look-ahead schedules and executed assigned work portion as per plans, in support of project milestones, Monitored actual project progress against baseline schedules and recommended corrective actions where necessary.
• Conducted regular status meetings wif all the sub-teams and prepared management status updates.
• Reviewed and approved Quality Management Plans (QMP), Inspection Test Plans (ITP), and Test Procedures etc.
• Reviewed and coordinated waiver requests and participated in evaluating change notices. Followed up in resolving contentious issues wifin the framework of contract requirements and project specifications.
• Reviewed and approved Vendor/Contractor invoices for contractual compliance.
• Managed Requests for Information/Clarifications (RFI/RFC) responses in a timely manner.
• Performed Cash flow analysis and ensured that cost reduction measures are identified and implemented on projects.
• Coordinated wif various departments like operations, maintenance and contractors for smooth execution of projects.
• Participated in safety review meetings, and assured compliance wif HSE (Health, Safety and Environment) requirements.
• Provided final drawing mark-up and as-built drawing coordination wif designers, final document control.
• Coordinated Punch List activity & timely closeout, implementing the approved Quality Control Plan (QCP) & project closeout procedures.
• Coordinated ‘Project Records’ documentation against deliverables list per contract, applicable standards & procedures.
• Ensured effective Transfer of Care, Custody & Control (TCCC) to owner department, conducted technical & financial project close out and recorded Project Management Lessons Learned and Best Practices.