client is looking for a Project Manager with medical regulatory and R&D experience around medical device manufacturing projects. They will assure the development of multi-level project planning to achieve short and long-term business objectives and track/report on all key product development and regulatory compliance programs.
Day to day responsibilities will include but not be limited to:
- Interfaces with cross functional teams (regulatory, quality, R&D, systems engineering, manufacturing, supply chain etc.) to ensure programs meet divisional goals.
- Guides development and documentation in line with QMS, standard operating procedures, specifications and test procedures.
- Participates in review boards for CAPA, complaints, business unit planning, and others as necessary.
- Reviews and provides functional approval for project and quality system documentation.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Proven experience working independently, leading and driving project deliverables while holding project team members accountable.
- Demonstrated proficiency of project charter, schedule/critical path management, budget, scope and risk management using the Project Management framework- PMBOK/PMI guidelines
- Strong ability to manage global projects with teams located in various sites and/or countries
- Ability to effectively communicate detailed information and strategic decisions, and respond to questions from project stakeholders of all levels
- Ability to draw out organizational requirements from and intelligently drive decision making with stakeholders
- Ability to direct and influence others to work within and deliver under rigorous timelines
- Commitment to sharing information transparently with team members and stakeholders at all levels
This role is based in Princeton, NJ with the expectation of extension into 2021.
The role will be reporting into the PMO and they are looking for candidates that would have the following experience in order of priority:
1. Project Management in the medical device domain specifically (no exceptions here)
2. They will be involved in a facility/lab expansion - so they would like the candidate to have quality and safety ISO standards around setting up a new lab environment (running clinical trials).
3. Experience with cross functional teams (reporting into the leadership team(s) and providing project status).
4. Experience with budgeting, contract mgt., status reporting.
The role will work with teams in Chicago and Ottawa - so a small amount of travel may be required (up to 20%) once the covid pandemic is under control).
They are looking for a candidate that has 5-7 years of experience and would by-pass the educational requirements if the candidate has the necessary professional experience.
Regards,
Shankar
Source Consulting
508-417-8385
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