Business Project Manager, Risk Management Submissions
Newark Metro Area, NJ
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
Track record of successfully coordinating a decentralized network of colleagues
Experience in supporting process development and impact assessment