Job description
Johnson & Johnson Family of Companies
Title: IFU Program Lead/Operations Lead
Location: Spring House, PA
Duration: 1 year
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.
Candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.
Summary:
The Program Lead shall oversee and coordinate the activities associated with the Primary Container and Device (PC&D) Instruction for Use (IFU) program. The Program Lead will be responsible for the planning, development, and project management of RND instructions for use.
The individual will be the single point of contact within PC&D for IFUs and working with internal and external stakeholders to ensure that the IFU needs of the clinical portfolio are met within the project's timelines.
Responsibilities:
- Oversee the activities of an (internal and external) graphics art and IFU development teams.
- Review proposals and ensure they are consistent with project and business needs.
- Review project requests and determine the project stakeholders to support.
- Work with combination product development teams to create project schedules with key milestones.
- Project management the development and delivery of instructions for use to be used in clinical trials or potentially commercial applications.
- Establish and maintain program budgets and report periodically to internal stakeholders.
- Review IFUs and ensure best practices are followed and consistent with Janssen internal guidelines.
- Develop written procedures and documents to support the implementation of the IFU development program.
Qualifications:
- BS/BA in Engineering, Business, Project Management, or other similar degree
- Have experience managing outside contractors and review proposals
- Experience in developing instructions for use in the pharmaceutical or med device setting
- 5+ years in leading team
- Knowledge of PowerPoint, Excel,
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