Job Description :
Regulatory Affairs Project Manager
Pittsburgh, PA
6+ months
Phone and Skype
The top skills are:
Top 4
1. Must have pharmaceutical experience.
2. Must have knowledge of the SDLC ( Software Development Life Cycle)
3. Must have strong people skills - understand that people have multiple views, but the ones that matter are only superiors
4. Would love to see people with Regulatory Affairs experience.
The full job description can be found below:
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 Mylan 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.
Qualifications:
Minimum of a Bachelor''s degree (or equivalent) and minimum of 6 years of project management experience required. Master’s degree preferred. Related education/and of experience may be considered.
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.
Prior experience of working with Regulatory Affairs required. Pharmaceuticals industry experience is required.
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
Thanks and Regards,
Shivangi Singh | Team Lead | KPG99, INC
Certified Minority Business Enterprise (MBE)
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