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Regulatory Affairs Project Manager


R&D Project Manager – Life Sciences

The Project Manager is responsible for the overall planning, management, and completion of customer implementation projects with infrastructure projects, enterprise software implementations, or other GxP related systems projects. In this role, you will work closely with the key stakeholders at the client site and manage the full project life cycle in which a successful customer implementation is achieved.

Specific knowledge and experience in Regulatory, R&D, RIM is required. Pharmacovigilance experience is a plus!


  • Develops project plans that establish clear roles and deliverables agreed upon by the Customer and team members which identifies and sequences the activities needed to successfully complete the project.
  • Assigns, schedules, reviews, and monitors project work to ensure that progress is within expected guidelines and is completed on time, within budget (per order and SOW) and meets established quality standards.
  • Organizes and manages recurring project team meetings between Core Informatics and customer team members to review the plan and deliverables.
  • Maintains effective communication and working relationships with customers and project team members.
  • Obtains ongoing feedback from client in terms of project management performance and key performance indicators being met.
  • Develops and captures metrics to support continuous evaluation of active and complete projects to support process improvement around cost estimation, time estimation, and other relevant factors that impact execution.
  • Participates in the establishment of good project management practices by defining and documenting policies and procedures, creating standard documents (templates, etc.).
  • Effectively manages resource demand across multiple projects in line with priorities and risks.
  • Additional responsibilities as deemed necessary by supervisor.

Required Qualifications

  • 5+ years of IT project management, infrastructure or enterprise software implementations or upgrades, or other GxP related system projects in the R&D / RIM/ Regulatory environment. Pharmacovigilance/Safety is a plus!
  • Bachelor's Degree or equivalent experience
  • Strong understanding of Information Technology and delivery of enterprise software to customers.
  • 2+ years in client facing role
  • Proficient in creating and making presentations to key stakeholders and upper management.
  • Expertise and experience managing complex, high-value projects
  • Considerable ability to establish and maintain effective working relationships across internal groups and customer representatives.
  • Considerable problem solving and decision-making skills.
  • Formal training in project management and tools like Microsoft Project, SmartSheet, etc. to create and manage project plans in terms of WBS, milestones and resource management is a plus.

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NNIT A/S - hurtigt overblik

IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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