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Business Project Manager, Risk Management Submissions

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -122019-26052 Region: Newark Metro Area

Job Description


The Business Project Manager, Risk Management Submissions, is accountable for providing project management support for the creation, review and submission of Risk Management material to global health authorities. This includes, but is not limited to, project planning, directing and managing project execution, monitoring and documenting project work, and scheduling of all project activities. The PM is accountable for ensuring that all workstream plans are effectively and efficiently executed and delivered successfully against expectations, remaining on-time and within scope. The PM is responsible for providing necessary updates and input into status report meetings to support successful delivery of submissions to global health authorities.


5+ years of experience in Project Management, with progressively increasing responsibilities in delivery and project management


Experience communicating with all levels of the organization; familiar with change management principles

Experience working in complex, cross functional, multi-cultural and global environments

Pharmaceutical/Biotechnology industry experience.

Expertise in MS Project, Excel, and other project management tools


Risk Management/ Pharmacovigilance experience

Risk Management Document submissions (REMS, RMPs, aRMMs)

NDA/MAA submission experience

PMP or similar certification

Process mapping

Track record of successfully coordinating a decentralized network of colleagues

Experience in supporting process development and impact assessment

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