Project Manager, Combination Products Development

• The Project Manager, Combination Products Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.). The Project Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

location: North Chicago, Illinois
job type: Contract
salary: $75.00 - 95.70 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
Summary of Responsibilities and Accountabilities:

• The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio.

Responsibilities include:

• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
• Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
• Representing the R&D organization to cross functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions

qualifications:

• Required: Bachelor's Degree in Engineering or related technical field
• Certification: Project Management Professional (PMP) Certification preferred, but not required
• 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
• Leadership of technical professionals; proven effective leader to cross-functional teams
• Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.
• Requires an in-depth understanding of the pharmaceutical and device product development cycle.
• Design history file, project management and product development experience is essential.
• Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.

#LI-ST1

skills: Project Management, MS-Project, PMP, Chemistry Manufacturing and Controls (CMC)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.