Project Coordinator at Franklin Lakes

Job Description

Description As a member of the BD Pharmaceutical Systems - Self Administered Injectable Systems (SAIS) business, you will have the unique opportunity to play a vital role in the rapid scale-up of an exciting new business platform that will be a key contributor to BDs future growth. Our mission is to become a world-class, customer focused organization that will have a significant impact in improving how patients receive drugs for their chronic conditions. You will have the advantage of combining the best of both worlds: the agility and creativity of a high-growth, start-up environment, and the backing and resources of a Fortune 500 company. We are actively recruiting high caliber talent across multiple functions that share our passion for excellence. We seek highly innovative, talented individuals motivated to design and build this family of self-administered injection products from the ground up. If youre interested in being part of the team bringing exciting, revolutionary products to the self-injectable market, read on... The Project Coordinator position reports to the Manager of R&D within the Self Administration Injectable Systems (SAIS) organization, and will consist of the following key responsibilities: GENERAL SUMMARY The primary role is to provide project management support. The scope of support will include but is not limited to the following:1) Managing the creation and approvals of Design Control Documentation2) Managing and updating Design History Files3) Helping manage internal and external communications.This person will be an integral part of the product development team and will continually interface with key functional areas to help maintain cross functional project alignment and focus on key project issues, deliverables, and tasks. RESPONSIBILITIES - Creation and management of Design History Files in accordance with unit and corporate quality systems procedures- Management of project document approvals process- Communication with supplier vendors- Implementation of new, integrated business processes- Help update the Design & Development and Project Plans- Collect/Acquire the project team updates and incorporate those into unit reports and presentations- Assist in creating/utilizing tools to support project metric reporting to key stakeholders- Support the project teams to track, update, and refine project tasks, resources and activities- Assist the Project Technical Lead in collecting, analyzing, and updating the project plan related to their area of responsibility- Support teams during unit, corporate, customer and regulatory audits.- Support Program Manager in documenting, refining, and rolling-out key processes and procedures within the department- Assist the Program Manager in creating and updating the Stakeholder communication Tools.- Support managing and updating of the units SharePoint data sites- Support and guide project teams on the proper use of meeting management tools and techniques- Manage project activities within the project team in line with project objectives and deliverables.- Ensure close working relationship with the project Core Team Leader, Core Team Members and Extended team members- Ensure project documentation and compliance is commensurate with BD corporate and site expectations.- Provide support for key project activities, project phase and technical reviews.- Provide support for training / development of project team members.- Provide support for graphics approvals to ensure compliance to BD Identity guidelines.- Ensure compliance with BD quality policies, cGMP, procedures and practices through appropriate communication and training.Additional information on competencies required- Good level of project management skills.- Effective communication, presentation and documentation skills.- Well organized and effective at maintaining confidential information- People management skills.- Knowledge of GMP, Quality and Regulatory requirements for the medical device industry preferred- A desire and tenacity for learning and problem solving- Process Oriented and capable of developing processes- Detail Oriented yet can manage to the big-picture- Demonstrated ability to meet deadlines EXPERIENCE - Proven track record in documentation and project management - Advanced MS Office and MS Project Skills preferred - A General Understanding of Regulatory requirements surrounding Medical Devices Qualifications - Associates Degree required, Bachelors degree preferred in Engineering or related technical field

- A minimum of 3-5 years of experience in the Medical Device Industry

Job Requirements

 
Country: USA, State: New Jersey, City: Franklin Lakes, Company: Becton Dickinson.