PROGRAM MANAGER WITH DEVICE, CMC Based in Gaithersburg (potential to work from home 1 day a week) preference is to be onsite, open to PM candidates that are strong even if they don't have a lot of Device experience; a baseline knowledge of Device with very strong PM skills may be able to work too. Has potential to go perm if it's the right fit. Project Description:
AND PHARMACEUTICAL EXPERIENCE
The Project Manager (PM) consultant will support 2 to 3 projects depending on the stage and complexity level of the program. Project assignments will include pipeline, life cycle management, technology and/or continuous improvement initiatives. In this role the PM will work with limited direction and will effectively prioritize and manage their workload to meet Team goals. The PM is expected to support project activities with the flexibility to coordinate meetings and travel to enable global time zone interactions dependent on project needs.
In partnership with the Device Lead & the CMC Project Manager, the Device Project Manager will facilitate translation of the device strategy into a plan and drive execution at the Team level together with the Device Lead. The Project Manager responsibilities will focus in 3 key areas to enable execution of the device strategy within the agreed-upon constraints of scope, time and cost:
- Facilitate effective planning with the Team to define development plan, timelines, critical path and identification of resources responsible to execute to plan.
- Drive execution of Team activities to meet project and design control deliverables.
- Facilitate project team communications and collaboration, in partnership with the Device Lead and CMC PM, to promote a collaborative team environment and maintaining positive team dynamics, decision making and on time execution.
- A variety of processes and tools will be used to manage the information flow & meetings (communication), team dynamics, budget, schedule, compliance and project risk management.
- The PM will also collaborate with Device Development (DD) leadership and cross functional leadership to help further define best practices for the Device Development PM function and drive consistency and alignment between project teams and to new Device PMs.
- Depending on projects and team locations, PMs may be required to coordinate meetings before 8 AM to accommodate international time zones. Limited travel is expected, and any travel will require prior management authorization. The PM is expected to enroll in the required training based upon business and project need.
Scope of Accountabilities & Activities:
- B.S. or B.A. degree (preferably in science or engineering discipline) and 7 to 10 years relevant business and/or technical experience in the medical device, pharmaceutical or biopharmaceutical industry preferably from a multi-site global company.
- 5 years Project Management experience in combination products
- Qualified candidates must have a proven track record leading development projects and an in-depth knowledge to apply project management methodologies and Design Control requirements.
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, ever-changing, team-based environment.
- Excellent written and verbal communication, listening, negotiation, presentation, organizational and relationship-building skills required.
- Proficiency with Microsoft Office suite and tools.
- Some travel expected dependent on project assignment.
- Expertise in the drug development process - demonstrated practical experience and knowledge of medical device development and commercialization.
- Ability to integrate science, drug and device development knowledge and regulatory expectations to execute project plans.
- Knowledge of relevant regulatory and Health Authority requirements and expectations applicable to drug development and design control requirements.
Collaboration and Teamwork
- Team building: Assess team dynamics and lead team development activities to enable high performing team environment
- Establish relationships and network with other stakeholder teams and PMs as needed
- Develop and adapt project communication tools (e.g. timelines, dashboards) to drive awareness of project progress & risks.
- Facilitate timely project decision making, problem solving and conflict resolution
- Liaise with other teams and sub-teams to address cross-functional activities, issues & risks.
Project Process Management
- Strategic Direction: Leads translation of strategy into project plans and deliverables, communicates plans to the team as well as Device Development leadership and key stake holders as appropriate
Project Planning & Execution
- Schedule: Develop, monitor, and control the detailed Device Team project schedule.
- Oversee project plan execution for deliverables and milestones.
- Lead project deliverable integration with Teams associated with the product deliverables.
- Meetings: Facilitate Device Team meetings with meaningful desired outcomes, minutes & follow ups as needed.
- Knowledge Management: Ensure team access to all relevant project information
- Project Issue & Risk Management: Facilitate resolution of Team issues and conflicts
- Work with Device Development Management and PMs to refine DD PM process
This 10+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: URL blocked - click to apply
ALPHA'S REQUIREMENT #19-01212
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE