*Hybrid 3 days/week to EITHER Rahway, NJ or West Point, PA
*12 month contract but renewing yearly
Our client's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.
Job description
- Collaborate with cross functional team members and support drug-device combination product program technical and engineering leads to develop and maintain project timelines.
- Track project milestones, deliverables, and risks; prepare reports/dashboards/risk register that summarize key progress and issues on development programs across different device project teams, including preparation and presentation of routine updates to management.
- Support teams through the effective execution of management-approved strategic plans for assigned projects; this includes ensuring key milestones are tracked, risk management plans are fully developed, deliverables/decisions are agreed upon and adhered to, communications within and external to the team are clear and effective when significant program deviations are encountered.
- Support teams through scenario planning to evaluate the pros and cons of proposed scenarios, identify constraints and trade-offs between different scenarios, and provide new/updated timelines as needed.
- Ensure project data are accurately reported in databases and understood by development team members and governance forums, including information used to derive costs, schedule, resources, and any other data pertinent to creation and management of project plans.
- Ensure that team meetings have structure and clear purposes and goals; facilitate meetings, issue meeting minutes and clearly communicate decisions and action items to team members and relevant parties outside of the team.
- Collaborate with project managers of the Development and Commercial Team and other working group and sub-team leads to integrate their timelines with the device development timeline.
- Provide input/direction on program timeline needs to internal and external sites and integrate timelines from suppliers and sites into the device development timeline.
- Develop and manage material demand schedule and interface with external partners & sites to ensure availability of materials needed to support product development and commercial capability build activities.
- Take relevant training courses to increase knowledge of the discipline of project management and understanding of drug-device combination product development in the pharmaceutical industry and to improve leadership skills.
Requirements
- BS/MS with 5+ years of medical device/pharmaceutical/biotech industry experience, including 3+ years project management related experience.
- Project management experience and/or certification.
- Must have good skills with electronic tool/software including MS Office, MS Project, Power Apps and Power BI.
- Understand the medical device and drug development process well and be good at data analysis/summary. Demonstrated experience/skills on risk identification, analysis and mitigation.
- Experience with medical device design controls and risk management is a plus.
- Excellent communication and interpersonal skills in addition to proven experience negotiating, managing change, goal setting, planning and organizing, teamwork, addressing difficult situations and understanding technical information.
- Strong conflict management skills to drive consensus among internal team members/functional leaders in accomplishing project and business goals.
- Demonstrated strong ability to work independently and accomplish goals in team settings; experience in leading task forces for assigned work. Proven ability to effectively keep projects and assignments on track or properly rescoped with management approval.
- Can relate project details to larger divisional/corporate strategies, as appropriate, to provide context to team.
- Demonstrate good judgment and creativity in team environments. Be agile to identify the potential risk and can provide innovative solution to handle the challenge/issue.
- Knows when and how to speak up and appropriately raise issues to the team and management.