IT Project Manager – Regulatory Affairs

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Company: JBS Technologies
Location: Pittsburgh, PA

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Role : IT Project Manager – Regulatory Affairs
Location : Pittsburgh, PA
Duration : 12+ Months
MOI : Phone/Skype

Responsibilities

  • Leads the creation of project management plans that clearly define the project scope, assumptions, risks and overall project approach including project resource needs, high level timelines, and project communications.
  • Develops and administers project budgets, schedules, and performance standards. Coordinates and responds to requests for changes from original scope.
  • Assigns duties, responsibilities and scope of authority to project personnel. Directs and coordinates activities of project personnel to ensure the project progresses in scope, on schedule and within budget.
  • Drives compliance with the IT Quality processes and SDLC process, including the IT change management and quality/testing process.
  • Analyzing scope of work to define the project goals, prioritize the project activities as per the project plan and manage resources.
  • Enforcing Systems Development Life Cycle standards and required regulations to projects.
  • Collaborating with key users of various business functions and harmonizing the business processes for various functions of R&D and manufacturing facilities across geographies.
  • Driving the project delivery to ensure conformance to predetermined schedule, budgets & milestones of the projects.
  • Communicates project status to project steering committee and other stakeholders as appropriate. Manages project issues/risks in a timely manner and appropriately escalating when necessary.
  • Provides leadership and motivation to project management resources. Mentors, coaches, and trains others in project management best practices.
  • Collaborates with solutions lead and business partner to ensure technologies are meeting the requirements.

MUST HAVE SKILLS

  • Prior experience of working with Regulatory Affairs required. Pharmaceuticals industry experience is required.
  • SDLC experience
  • PMP certification preferred.
  • Must possess extensive knowledge of project management concepts, practices and procedures as they relate to the delivering IT project.
  • Must understand and apply all the Project Management Body of Knowledge Competencies.
  • Must be a self-starter and able to multitask. Achieves high results through people and works well in and appreciates the value of a globally diverse management, employee and contractor environment.
  • Ability to work well in a team setting and independently. Performs well under pressure. Shows diplomacy, tact and good judgment when conflict arises.
  • Proactively plans for managing and mitigating project risk. Can see the larger picture, able to identify patterns or connections between situations not obviously connected; able to identify key issues in complex situations.
  • Possesses a clear vision of project direction/outcome and ability to communicate this vision; instils a sense of project ownership.
  • Work effectively in a highly matrixed environment where resources report to both functional and project leads. Has ability to manage expectations of project sponsor and stakeholders regarding scope and deliverables.
  • Must possess strong written and verbal communication skills and be detail oriented.

Job Type: Contract

Experience:

  • Pharmaceuticals: 2 years (Required)
  • IT Project Management: 5 years (Preferred)
  • Regulatory Compliance: 2 years (Required)

Location:

  • Pittsburgh, PA (Required)

Contract Length:

  • 1 year
  • More than 1 year
  • Varies