Associate Director, Global Regulatory & Safety Resume Example
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ASSOCIATE DIRECTOR, GLOBAL REGULATORY & SAFETY
Professional Summary
- Business strategist and technical architect poised to contribute unique blend of leadership in technical analysis, solution architecture and design, along with commitment to excellence by ensuring that projects support strategic business objectives within scope, budget, and schedule.
- Digital CapabilityManager offering 16 years of success leading all phases of diverse technology projects.
- 14 years of technical leadership experience in the Biopharma R&D IT, Healthcare IT, Life Sciences and Regulatory Management industry.
- Program Manager with experience in planning and managing multimillion-dollar projects, aligning business goals with technology solutions to drive process improvements, competitive advantage and bottom-line gains.
- Expert in agile and waterfall project management methodologies; managed large project teams and known for high-quality deliverables that exceeded timeline and budgetary targets.
- Excellent communicator; leveraged technical, business and financial acumen to communicate effectively with client executives and their respective teams.
- Creative thinker and analytical problem-solver with demonstrated ability to manage projects from planning through execution/completion under the pressure of fast-paced, time-sensitive environments.
- Expertise in designing 5-year digital capability roadmaps in line with business roadmap & enterprise architecture strategy, focusing on speed, quality, & cost.
- Ability to achieve successful consensus among differing priorities and stakeholders in IT and Business communities.
- Relationship building, cross-functional / multi-site matrix management and team building experience.
Skills
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Work History
Associate Director, Global Regulatory & Safety06/2020 to Current
Tsr, Inc. – Devens , MA
Tsr, Inc. – Devens , MA
- Implement and support strategic information systems that globally enable Enterprise Architecture & Platforms (EA&P) to develop and execute innovative medical IT strategies to rapidly deliver safe and effective medicines to patients.
- Proven abilities to plan, manage, deliver, and support strategic digital capability programs, from concept initiation through delivery and steady-state operations.
- Strong practical working experience with Regulatory, Medical and Commercial capabilities with demonstrated command of key concepts, systems and processes.
- Support experience in dealing with complex technical issues and working with key business stakeholders to develop and provide solutions for short-term remediation and long-term strategy.
- Monitor financial health of projects/program and oversee portfolio lifecycle costs
- Coordinate plans and activities that ensure the success of an evolving GRSS operating model, including integration efforts resulting from M&A activities.
- Instantiate and lead the PMO team to Initiate, Plan, Execute and Close PMO managed projects.
- Lead initiatives that drive the strategic portfolio of work across the organization.
- Create and publish routine dashboards and reports that effectively communicate progress, risk and achievements of the overall project.
- Support planning of internal and external events, people engagement activities, as well as executive level presentations and tracking mechanisms to ensure communications of progress and risk mitigations to stakeholders (internal and external).
Digital Capability Manager10/2011 to 05/2020
Fiserv, Inc. – Lincoln , NE
Fiserv, Inc. – Lincoln , NE
- Manage cross-functional teams including technology leaders across analysis, architecture, build, quality assurance, deployment and support teams on project execution.
- Guide, coach and lead project teams, delegating tasks and evaluating performance and progression of project pace.
- Lead infrastructure feasibility analysis, generate cost / risk / performance estimates for new initiatives.
- Facilitate Regulatory and Security Risk assessment and remediated assets as needed.
- Provide technical leadership on projects, ensure cross project/team information sharing, and mature Solution Architecture in compliance with Enterprise Architecture guidelines.
- Set and track KPIs to drive team performance and to manage risks.
- Experience in evaluating commercial products (e.g., software packages) and services and influencing the negotiation process for vendor products.
- Liaise between business and technology units to manage delivery schedules for applications.
- Manage deliverable estimates, negotiated resource conflicts, and manage resource pool on projects in alignment with best practices and methodologies.
- Generate earned value management data capture metrics and reports for management.
- Partner with IT Business Partners to define, plan for, prioritize, deliver & support strategic digital capabilities and ensure maximum value is achieved.
- Direct multiple work stream project plans into a cohesive whole by building and executing integrated project plans.
- Evaluate project and program performance periodically with key performance indicators and develop action plans to achieve performance goals.
Program Manager04/2007 to 09/2011
Kion Group – Plano , TX
Kion Group – Plano , TX
- Lead projects involving software solutions (SaaS model) facilitating point-of-care electronic Prior Authorizations for drugs, medical procedures, lab tests and DME process, claims review, ePrescriptions, and EMR.
- Lead multiple software technical infrastructure projects though full project life cycle stages from analysis through transition to support.
- Provide status updates on project progress, risk management, change requests and technical issues to management.
- Manage cross-functional project teams of analysts, designers, architects, developers, SMEs, management, peers and other stakeholders by building strategic work relationships.
- Aggressively drive program-level decisions and progress through development of risk response plans and needed executive escalations when critical risks were identified.
- Assist Change Control Board in maintaining the Project Change Management log documenting changes along with the potential impact to schedule / scope / cost.
- Proactively identify new business opportunities with existing clients based on business process and application knowledge.
Software Analyst01/2005 to 02/2006
Refinery Inc – City , STATE
Refinery Inc – City , STATE
- Lead testing of regulatory software solutions and related services for the Life Sciences industry.
- Lead a team of Quality Assurance analysts in the Quality Control department to create detailed test cases with complete coverage of functional and technical requirements.
- Strong knowledge of lifecycle linking, XML creation and paper requirements, traditional submission product requirements, eCTD submissions and updates for regulatory compliance.
- Demonstrate strong understanding business context, analyze business requirements, functional specifications and detailed design documents.
- Strong hands-on experience with using Documentum for retrieving, storing, updating and maintaining version control for all project related documentation using both the Web and Desktop clients.
- Champion the importance of product quality by executing on testing as an embedded member of a Scrum team.
- Collaborate with stakeholders, engineers, and developers as part of the development life cycle.
- Facilitate all phases of tests from planning, developing, executing and revising plans and scope.
Accomplishments
- Creative thinker and analytical problem-solver with demonstrated ability to manage projects from planning through execution/completion under the pressure of fast-paced, time-sensitive environments.
- Business strategist; plan and manage multimillion-dollar projects aligning business goals with technology solutions to drive process improvements, competitive advantage and bottom-line gains.
Education
Master of Science: Computer ScienceFlorida State University-
City
Bachelor of Technology: Computer Science & EngineeringGMR Institute Of Technology-
City
Certifications
- Certified Project Management Professional, PMP
- Certified PMI – Agile Certified Practitioner (PMI – ACP)
- Certified SAFe Agilist, Scaled Agile, Inc.
- Certified Salesforce Administrator, Salesforce.com
- Certified Salesforce Developer, Salesforce.com
- Certified SAS Developer, SAS
Affiliations
- Member, Project Management Institute
- Member, Project Management Institute – New Jersey Chapter
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Resume Overview
School Attended
- Florida State University
- GMR Institute Of Technology
Job Titles Held:
- Associate Director, Global Regulatory & Safety
- Digital Capability Manager
- Program Manager
- Software Analyst
Degrees
- Master of Science : Computer Science
Bachelor of Technology : Computer Science & Engineering
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