Responsible for compiling reporting status and critical issues to management and customers. Provides analysis for project plans and schedules to identify critical path(s), optimize plans, facilitate discussions between team members.
Leads programs with high resource requirements, risk, and/or complexity
Leads customer and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned projects/programs.
Drives transparency of program workloads, financial, commitments, and expectations.
Build, track, and manage program schedules in Microsoft Project.
Maintain the program related data within the West Project Management System.
Monitor resource needs and issues, work closely with resource managers to develop action plans to ensure program commitments remain on track.
Manage cross-project and program dependencies, escalating to the Research and Development management as needed.
Analyze, Forecast and Report the program budget.
Ensure Research and Development programs are planned properly, including financials, resourcing, scheduling, and the business case, in support of quality deliverables.
Define, drive and manage change management and communications activities that support assigned programs.
Lead/support the development of business cases on assigned programs and track ROI for business initiatives including cost, benefits, and risk.
Additional Responsibilities
Compliments team deficiencies and drives financial accountability.
Build and maintain strong relationships with customers, business partners, functional managers, and other senior level executives.
Solves complex problems with broad business impact.
Champion of the Research and Development PM/PDP process and methodologies.
Communicate Research and Development PM/PDP key messages, goals, and objectives to functional team members in their local geographies or business units.
Education
Bachelor's Degree Engineering (Preferred Biomedical or Industrial Engineering) required
License and Certifications
Program and Project Management\Certified Project Management Professional (PMP)-PMI preferred
Work Experience
Minimum 8 years successfully managing global large-scale, high-risk programs required
Program Management experience with matrix and cross-functional project teams required
Medical Materials, Medical Device and/or Drug Delivery Systems product development preferred
Prefillable syringe industry experience preferred
Preferred Knowledge, Skills and Abilities
Working knowledge of applicable federal and international regulations such as 21CFR Parts 210, 211, and 820. cGMP manufacturing experience preferred.
Proficient with Microsoft Office suite software, project management software such as MS Project.
Knowledge and demonstrated experience managing projects or programs in the medical device and pharma manufacturing industries, knowledge of applicable federal and international regulations.
Experience and capability at delivering written and verbal reports to senior and executive management.
Demonstrated ability to manage multiple globally dispersed individuals and disciplines. Must possess the ability to influence others without direct authority.
Requires specialized depth and breadth of expertise in industry, Program Management, and business acumen.
Works independently, with guidance only in complex situations.
Cultivates teamwork through leadership and fills knowledge/skill gaps on project teams as needed.
Communicates complex concepts; anticipates potential objections and influences others to adopt a different point of view
Interprets internal/external business challenges and recommends best practices to improve products, processes or services
Drives/Supports functions with the preparation of business cases, plans, budgets and artifacts necessary to comply with the Portfolio Management Process.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.