SENIOR PROJECT MANAGER
For this position, we are looking to hire a hands-on member of the team, responsible for planning and execution of product development project(s). This person will be responsible for creating and maintaining the project plan and schedule. After the plan has been created, they will ensure that it is kept current, reflects any authorized changes, and that change implications have been thoroughly understood across all departments as well as senior management. This position will work with all functions in the organization and will be expected to grasp general knowledge across multiple disciplines.
We are looking for a bright, curious, energetic, enthusiastic individual with attention to detail with Project Management. They must be be able to work effectively in a fast paced, informal, entrepreneurial, medical device/drug development company.
Lead a cross-functional team and/or sub-team(s) that may include representatives from Pharmaceutical Development, Electronics, Software (embedded firmware and mobile applications), Mechanical, Manufacturing/Supply Chain, Quality, Regulatory or Clinical functions to meet the objectives of a given project relating to the development of an electromechanical drug delivery system with a companion mobile application
Develop comprehensive project plan(s) that identify objectives, deliverables and schedule for new product development projects.
Track and report progress against project plan, communicate risk areas
Confer with project personnel to identify and resolve problems
Conduct and document Design Review meetings, planning meetings, and other cross functional meetings as needed, ensuring action items are completed in a timely and effective manner.
Minimum of a BS in Science or Engineering or a medical discipline.
5-10 years’ experience in the pharmaceutical and/or medical device industry with significant project management experience and exposure to the regulatory approval process.
Experience managing drug delivery system development and/or electromechanical product development programs, including electronics, software and mechanical, is desired.
Fields of Expertise:
Project management in an FDA regulated environment; strong competence in the use of Project Management tools.
Demonstrated leadership skills.
Proven capacity to build strong relationships across multiple functional areas.
Excellent planning, analytical, organizational and time management skills
Demonstrated success with scheduling and managing complex projects and cross-functional project teams
Excellent verbal and written communication skills
Demonstrated competence with Project Management tools including MS Project, Excel, and Power Point
Ability to travel about 5-10% of the time, both domestic and international
Interested in the Sr. Project Manager role? Please submit the following application form.