- Directly manages all aspects of the project life cycle and works with matrix IT partners to oversee all system development life cycle (SDLC) phases of a project.
- Rigorously manages priorities and scope to ensure commitments are achieved within agreed upon time, cost, and quality parameters.
- Develops communication plans and interfaces to execute on responsibilities.
- Ensures that the project is executed and managed according to Otsuka’s Standard Operating Procedures, Working Practices, processes and tools.
- Escalate unresolved issues to the project Lead, and Steering Committee leadership
- Identify, track, and resolve project issues in a timely fashion
- Develops the project charter, integrated project plan, resource plan, risk plan, and related project management artifacts.
- Publishes periodic project status reports.
- Manages the project change control process
- Travel (approximately 10%)
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Knowledge, Skills, and Competencies
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Required:
- Demonstrated 7 + years Project Management experience in Life Sciences managing cross functional and/or global projects from beginning to end
- Knowledge of the Life Sciences industry in the context of applying information technology and services,
- Knowledge of system development lifecycles (SDLC) with general understanding in the areas of application development, database, and system design.
- Strong Vendor Management and Business Liaison skills
- Knowledge of regulated environments, FDA regulations, including 21 CFR Part 11, quality standards, validation lifecycles, ICH guidelines, including GCP, GLP and GAMP
Domain Knowledge:
- Expertise in implementing WinNonlin, NonMem, PKS (Phoenix) and other Pharmacokinetics applications in Pharmacology domain preferred
- Experience in managing vendor Experience with the Pharmaceutical industry computerized system solutions in general (Clinical Trial Management, Regulatory Affairs/Submissions, Data Management, and Clinical Safety).
- and contractor resources and interacting with Pharmaceutical Research and Development Business groups
Preferred:
- Skilled in the use of Relational Databases, Defect Tracking, and Configuration Management
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Education and Related Experience
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- Proven ability to quickly earn the trust of sponsors and key stakeholders; mobilize and motivate teams; set direction and approach; resolve conflict; deliver tough messages with grace; execute with limited information and ambiguity.
- Ability to navigate a highly matrixed organization effectively.
- Strong organizational and follow-through skills
- Demonstrated experience working in a Global Cross-functional environment.
- Solid influencing skills to help drive consensus.
- Sound business and technical acumen.
- Experience with stakeholder management.
- Focused and versatile team player that is comfortable under pressure.
- Ability to communicate at all levels with clarity and precision both written and verbally.
- Demonstrated Project Management skills (PMP Certification a plus)
- Analytical, Problem Solving, and critical-thinking skills.
- Ability to evaluate cost-benefit analyses
- Bachelor’s degree in Computer Science, Engineering, Business or a closely related discipline.
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