Global Submission Project Manager

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Date: May 15, 2019

Location: Raleigh, North Carolina, US

Global Submission Project Manager

Raleigh-Durham, NC or Atlanta, GA

The Submission Project Manager role is focused on the delivery of a project or set of responsibilities that will further the value creation for patients.  This is typically captured via the five stages of a project: setting the goal with the sponsor, defining the project strategy, planning the project, executing against the plan and closing out through lessons learned and measuring the impact.

The Submission Project Manager Skill set requires using standard project management tools such as a project charter, scope of work, budget, resources as well as scenario planning, risk/opportunity assessment, trade-off analyses, and partnering with stakeholders to appropriately prioritize and execute the project. These deliverables contribute to the company’s success and depending on the project, may take a long-term view. 

Additionally, the Submission Project Manager requires working knowledge of the Common Technical Document, Drug Development and Regulatory Filing procedures.

 

Operationally, the Submission Project Manager will be focused on driving the submission team in alignment with the Project plan, including meeting outcomes/actions, budget preparation (where applicable), challenging of resource estimates and utilization, and on adherence to agreed timelines. The Submission Project Manager acts as champion for Project Management techniques and processes, coaches team members in these areas and shares lessons learned for continuous improvement.

 

MAJOR ACCOUNTABILITIES

 

  • Collaborate on the development of strategic plan (charter) for the project. 
  • Identify internal team synergies and/or conflicts early and propose solutions in agreement with stakeholders.
  • Ensure operational initiatives aiming at rapidly piloting, developing and establishing efficient paths to market for new solutions.
  • Stakeholder management with relevant interfaces in and outside of the organization, including management of external partners as needed
  • Scenario planning for the asset/project – ensuring flexible and agile use of resources and funding. 
  • Representation of the project at “Governance” (e.g., PVU or GRA Leadership Teams), when requested.
  • Plan, track and monitor project progress across all Submission aspects, identifying problems, forecasting risks, and proactively seeking resolutions.
  • Ensure communication, alignment and integration between sub-projects, across Practices and other stakeholders incl. priority setting of different activities and deliverables
  • Budgeting: Regular forecasting and review cycles, align with Finance on budget process & timelines and secure execution and tracking within missions/sub-teams.
  • Track and monitor performance of the team/project against annual and long-term objectives (resourcing, information gathering, data analysis, draw conclusions and status reporting).
  • Meeting Management incl. setting agendas, minutes and follow up on key actions with stakeholders
  • Train others in the team on project management concepts and processes as appropriate.  Ensure onboarding of team members.
  • Manage project tools, e.g. Integrate, SAP, SharePoint, Integrated Project Plan as required by the project.
  • Create communications for internal and external stakeholders (content perspective) incl. information gathering, making sure strategic concepts are in alignment.
  • As member of the PM CoE, drive best in industry practices by contributing lessons learned, challenges, solutions and involvement in process improvement projects.

 

Experience

 

A university graduate (Bachelor’s required, Master’s Preferred) with a minimum of 5 years working experience from either a cross-functional role or from a line function. Has worked in a global environment with matrix structure and/or project organization with strong project management experience, in the pharmaceutical industry, CRO or comparable partner organization for drug development.

 

Specific skills

 

  • Project Management techniques & people management in projects
  • Working knowledge of the Common Technical Document, drug development processes and Regulatory Filing Procedures
  • Financial knowledge (e.g. in budgeting, forecasting & KPIs)
  • Commercial/business acumen
  • Excellent self-management, priority setting and planning skills
  • Skilled in communication and influencing across the organization
  • Establishes/maintains working relationships, sensitive to group dynamics
  • Excellent in relevant IT solutions  
  • Very good English literacy
  • Facilitating/negotiating skills
  • Manage uncertainty and risk
  • Manage conflicts


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