Boston, MA, West Chester, NY OR Newark DE
Relocation Assistance OR Remote Option Available
Competitive Salary + 10% target bonus, 401K Match, Great Benefits
We have an immediate opening for an experienced Project Manager with a longstanding client; a multi-billion ($8B+) global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's lives. A lot of the work they are currently doing is completely next-generation new product development, very exciting cutting edge products.
We are looking for a very strong Project Manager to coordinate complex work across Core Teams (R&D, Manufacturing, Labeling, Technical Writing, Quality/Regulatory, etc). This position is responsible for managing the development and release of all deliverables on new product development teams for a major development program. This position is responsible for developing and maintaining detailed project plans, project budgets, and design control documents (e.g. project plan, design input requirements, design outputs, verification plan & report). This position will be responsible for managing and delegating tasks to assigned resources to ensure high quality, on-time completion of design outputs and project deliverables. This position operates as a strong project manager, strong leader, independent subject matter expert, knowledgeable resource, facilitator and coach.
This role works in the complex world of Product Labeling but does not require expertise in this area. You will work closely with cross-functional core team member to ensure successful completion of deliverables.
- Represent the project core team, working with cross-functional team members to ensure successful delivery of new product packaging, instructions for use and customer required documentation.
- Create, manage and maintain project schedule and budget for Product Labeling deliverables.
- Create, manage and maintain all required design control documentation.
- Oversee and delegate tasks to the team of Technical Writers, Graphic Designers and Proofreaders supporting project deliverables without direct line authority, to ensure deliverables are met.
- Identify critical path activities and work with various functions to eliminate road blocks throughout the project lifecycle.
- Actively participate in project team meetings to ensure successful completion of deliverables using standardized project tools and content management systems.
- Responsible for delivering standardized format and content for Product Labeling, providing support, direction and guidance to Technical Writers as necessary.
- Manage and oversee the development and release of each product labeling document from draft through release to customers.
- BA/BS required, Project Management Professional (PMP) certification preferred, but not required
- 6-9 years of experience as a Project Manager, Project Planner or Project Analyst, with a minimum of 3 years as a mid-level Project Manager, or higher, in an FDA regulated design control environment.
- Thorough knowledge and understanding of FDA design control requirements required.
- Experience as a Technical Writer and/or direct experience in the delivery of customer documentation desired - not required
- Understanding of product labeling processes and workflow, and relevant manufacturing processes desired - not required
- Leadership skills and ability to motivate a team without direct line authority.
- Positive attitude and ability to develop effective relationships with all levels of personnel.
- Experience working in IVD, medical device, pharmaceutical or other regulated industry strongly desired.