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Global Regulatory Affairs - Project Manager

Company: TalentBurst, Inc.
Location: Princeton
Posted on: September 21, 2022

Job Description:

Job Description

Role: Project Manager
Contract Length: 12 months with possible extension
Weekly Commitment: 40 hours
Location: Princeton, NJ (Zip Code: 08540) area preferred for occasional meetings but open to 100% remote ;

Description:
* Drive Global Regulatory Affairs projects and process improvement activities
* Actively engage and collaborate with the Global Regulatory Affairs Project Coordination and Compliance Lead and other GRA leaders to achieve the goals set out in the department
* Employ solutions to enhance processes, technologies, and activities
* Lead cross-organizational activities and ensure that team members are aware of and meet all expected deliverables and outcomes
* Develop, manage, and drive timelines and milestones for projects
* Raise new ideas and facilitate meetings to brainstorm and create solutions, as appropriate
* Responsible for coordinating and facilitating cross functional meetings and teams
* Manage and facilitate initiative and project team meetings with traditional project management deliverables such as creating and managing project reports, presentations, materials, meeting agenda and meeting minutes/outcomes and follow through on all deliverables
* Develop and maintain a project plan for all assigned projects
* Proactively identify activities that need to be completed and action them accordingly
* Ensure plans are implemented in accordance with timelines and any issues, challenges or deviations are escalated for resolution in a timely manner and ensure alignment of team activities
* Prepare presentations for meetings, cross functional forums and leadership requests
* Provide project management support for various GRA functions
* Support efforts to develop and maintain key performance indicators
* Interface with senior management on various projects and initiatives

Possesses the Following Knowledge, Education, and Experience Required to Fulfill the Contract:
Skills
* Required: Minimum of 3 years project management experience.
* Preferred:
* Knowledge of the drug development process and/or Regulatory Affairs.
* Demonstrated contributions that have helped innovatively transform processes, technology, roles, organizational activities and collaborations
* The candidate should have exceptional oral, written communication skills, presentation skills and be knowledgeable with software applications that will be regularly used (in particular; Excel, MS Project, SharePoint, Microsoft Teams and PowerPoint).
* Certification in project management (PMP) is desired but not required.

Knowledge
* Knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.

Education and Experience
Basic Qualifications
* Bachelor's degree or equivalent experience in life sciences, scientific, engineering field. Prior experience working in the pharmaceutical/biotech industry required.
* Experience managing cross-functional project teams

Keywords: TalentBurst, Inc., Trenton , Global Regulatory Affairs - Project Manager, Executive , Princeton, New Jersey

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