Vacancy caducado!
Please note that this is a 1 year contract position.Need onsite at least 2 days a week.Non-negotiable skills: Project management, presentation development skills, and financial reporting.Ideal candidate will have experience in developing instructions for use and have a good understanding of the regulatory framework associated with IFU and label development. Additional the candidate will have experience managing external contractors including reviewing proposals and financial reporting. Required QualificationsBS/BA in Engineering, Business, Project Management, or other similar degreeHave experience managing outside contractors and review proposalsExperience in developing instructions for use in the pharmaceutical or med device setting5+ years in leading teamKnowledge of PowerPoint, Excel,This job description is relevant to the contract IFU Program Lead role for the Primary Container and Device (PC and D) group within Research and Development.The Program Lead shall oversee and coordinate the activities associated with the PCD Instruction for Use 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 and 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.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 internal guidelines.Develop written procedures and documents to support the implementation of the IFU development program.Applicants must provide their phone number. Reference job number A3369.
Vacancy caducado!