- Title: Project Manager
- Code: RCI-5134
- Posted Date: 09/15/2020
- Duration: 6 Months
Talk to our Recruiter
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Candidates will be working remote foreseeable future. Person could remain remote for the duration of the assignment.
- Running remediation activities in a regulatory affairs
- Working with 15-20 people delivering documentation for product remediation
- Project plan
- Hold weekly meetings with core team to drive timelines and completion of times
- This is not an IT PM role. Not following agile or waterfall. Not systems based
- PM is highly desired. In a technical field of regulated environment
- High level of communication skills
- Medical device or pharma PM experience
- Technical expertise
- Development work to execute a product launch
- Strong communicator
- Highly organized
- MS project, SharePoint, MS Suite that includes outlook
- This person will be required to report out to leadership. (manager director level)
- BA is required
- 5+ years of experience in a PM leadership role in a regulated environment
- Focusing on leadership on small projects and leading a team through successful milestones
- Technical background
- Medical/Pharma experience
- Manages complex device projects within the B/U.
- Assures the development of multi-level project planning to achieve short and long-term business objectives
- Develops, tracks and reports on all key project deliverables.
- Keeps senior management team informed of progress and issues.
- Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects.
- Ensures project teams have appropriate resources to perform assigned tasks.
- Interfaces with appropriate internal and external resources to ensure intellectual property is protected.
- Reviews protocols and reports to support regulatory submissions.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international 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.
- Performs other related duties and responsibilities, on occasion, as assigned.