Sr Project Mgr, R & D
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Advanced Surgery, a leading business unit of Baxter Healthcare, offers a broad portfolio of surgical products and services to provide the quality, consistency, and support that healthcare providers depend on: flowable hemostats helping surgeons control bleeding, surgical sealants, soft tissue regeneration through biologic patches and meshes, orthobiologics bone-graft substitutes, and microsurgery focused on blood vessel and nerve repair. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
The Senior Project Manager (Sr.PM) will provide business and technical leadership for major, high complexity new product development programs. The Sr.PM will lead project teams through all phases of Baxter development process in compliance with US, EU, Japan, and other country regulatory and MOH agencies. This person will interact frequently with and influence executive level stakeholders. The Sr. Project Manager will make project completion, budget, and resource commitments and manage stakeholder expectations with regard to deliverables and funding during the programs. They will participate in organizational issue resolution and will lead teams through the identification of risks / issues and implementation of mitigations. This person will be a key member in developing core team and project management capabilities across the business unit.
Essential Duties and Responsibilities
· Lead the strategic planning, initiation, execution, and launch of new products and product extensions
· Leads team in defining project, developing goals and milestones, and ensures project scope is defined and controlled
· Must have experience with medical device development, 21CFR 820.30 and ISO 13485 at a minimum
· Understanding of ISO 14971 Risk Management and ability to drive team to success with Product Design Owner
· Must have experience working with, and basic knowledge of Engineering, Quality, Manufacturing, Supply Chain, Marketing, and Finance
· Sr PM works closely with Global Marketing and should have product launch experience
· Must be able to lead project teams of functional SMEs, wide range of knowledge, skill level, and communication levels, and bring out the best performance in non-reporting line personnel
· Interprets project strategy and helps translate into tactical actions and technical solutions
· Provides bi-weekly and monthly status updates to management
· Must be able to present project, discuss, and defend project at appropriate level to BU President and leadership team
· Must be able to simplify the complex and communicate to wide range of stakeholders and audience
· Responsible for developing project plan (project contract with management)
· Accountable for core team performance, creation and management of project schedule, execution of the project, and budget commitments and track spend monthly
· Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
· Ensures identification and communication of project risks, development of risk plan and leads core team in the proactive management of risk response strategies
· Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
· Critically evaluate existing processes, identify inefficiencies, recognize opportunities and optimize, where necessary
· May provide direct supervision of individuals and/or manage consultants
· Train / coach / mentor team members and other functional areas in systems, procedures and tools related to the project.
· Lead team through development of a project portfolio and establish and lead governance mechanisms to effectively manage the portfolio
Qualifications For This Role
· Basic knowledge of submission management processes, registration tracking, eCTD and Document Management Systems is highly desired
· Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
· Expertise in all aspects of project management with the ability to manage multiple priorities and projects
· Excellent oral and written communication and presentation skills
· Solid problem solving and analytical skills, and appropriately use data to make or recommend business decisions.
· Capable of recommending innovative solutions to complex problems
· Understanding of drug and/or device development processes, Quality Management Systems, Good Manufacturing Practices, Good Laboratory or Clinical Practices, and applicable regulations
· Effectively Demonstrated ability to supervise and develop others
· PMI (e.g. PMP, PgMP) or equivalent certification desired
· Travel up to 30%
Education and Experience
· A minimum of an Bachelor’s plus 7 years project management experience and 10 years of product life cycle experience with demonstrated success leading medical device/clinical drug development projects
· A degree in Engineering, Chemistry, or Science field is required
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.