Under general supervision, provides project planning and project management logistical support for designated projects within Operations. Coordinates launch activities for new products once they have been filed with the appropriate regulatory agency. Responsible for preparing, tracking, and updating project plans, timelines, and resource plans. Responsibilities include scheduling, chairing, and documenting project team meetings as well as preparing and updating status reports to ensure timely and cost-effective achievement of project milestones. Identifies customer issues that could harm customer relations and elevates to the senior management team for resolution. Additional responsibilities include coordinating and facilitating sensitive client communications for contract manufactured products.
Essential Job Functions:
· Responsible for all project planning and coordination activities for Company owned commercial products, contract manufactured products, and new products in late stage regulatory review.
· Responsible for coordinating project management activities for other high level Operations projects such as DEA, Florida Department of Business and Professional Regulations, and other projects that are essential to the success of the Company.
· Prepares project plans based on input from the departmental team members using Microsoft Project for designated projects.
· Prepares timelines and resource plans.
· Prepares project reports for senior management and clients as required.
· Tracks tasks and completion status for designated projects.
· Schedules and coordinates project team meetings and issues associated agendas/minutes.
· Maintains an understanding of contractual and regulatory obligations as they apply to designated projects.
· Provides project planning support including development and updating of associated planning tools.
· Provides logistical and administrative support for senior management as needed.
· Collects and assembles data into reports as required or directed by management and/or the customer.
· Coordinates RFQ activities between the customer and the Operations team to ensure proper costing for contract activities and tracks progress of these projects to coordinate invoicing activities with Finance when the projects are complete.
· Interacts and coordinates with the Operations team to ensure internal and external customer expectations are well defined and commitments are achievable and met.
Required Knowledge and Skills:
The incumbent must be able to interact and communicate effectively with colleagues at all levels of the organization. The incumbent must be extremely organized and must be able to coordinate and handle multiple projects at the same time. Strong computer skills are required. Previous experience with Microsoft Project (or equivalent planning tool) is essential. Excellent oral and written communication skills required. Strong mathematical skills required. Working knowledge of FDA regulations and cGMPs requirements will be provided by Aveva in order to fulfill job requirements.
Bachelor Degree in Science, Business, Engineering, or related discipline with a minimum of 2 years of project management experience. Relevant experience in the Pharmaceutical, Biotechnology, or Medical Device industry a strong plus. Proficiency in Word, Excel, and PowerPoint a must. Proficiency in Microsoft Project a strong plus.