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Remediation Project Manager (REF10620T)

Company: ProPharma Group
Location: Lawrence
Posted on: June 21, 2022

Job Description:

Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.Job DescriptionThe Project Manager is responsible will assist and manage several remediation workstreams in response to a FDA warning letter. the candidate will needs to have specific Project Management of warning letter remediation experience. The expectation will be this person will work with the project teams and the laws firm to drive the remediation workstreams to conclusion. This person will need to have a high level QA background as well. This project is onsite in Lawrence, KS and duration is 3 months+.Essential Functions Include

  • Oversee planning, direction and coordination of strategic projects from initiation through implementation.
  • Lead cross-functional teams to establish new or enhanced products, services, capabilities or processes.
  • Work with leadership to define project scope, objectives, and outcomes for each initiative through formal charter, project plan, and other supporting documentation.
  • Identify colleagues required to participate in project teams (in conjunction with leadership and subject matter experts).
  • Develop detailed project plans including (but not limited to), milestones, tasks, responsible parties, timing, and dependencies.
  • Communicate project status to leadership and other stakeholders, including timely escalation of issues.
  • Establish and maintain all project-related documents and artifacts in a central location (e.g., SharePoint).
  • Monitor progress of project activities, identify risks and issues in a timely manner, collaborate with colleagues to resolve issues, and adjust project plans as needed.
  • Liaise with Business Systems Analysts on requirements gathering and documentation in support of IT-related initiatives.
  • Ensure projects are delivered on-time and meet agreed standards or quality.
  • Evaluate project outcomes in conjunction with leadership.
  • Provide project status updates on a weekly basis.
  • Provide project-related support to leadership in preparation for executive-level meetings.
  • Other duties, as assigned.Qualified Candidates Must HaveQualifications
    • Bachelor's degree in health administration, business or related field.
    • Must have Project Management of warning letter remediation experience
    • Minimum of 3 to 5 years project management experience.
    • Industry experience in pharmaceuticals, healthcare or related business.
    • Experience in operations, quality, project management, or related fields.
    • International work experience a meaningful plus.
    • Ability to facilitate and lead cross-functional meetings with C-level participants and subject matter experts.
    • Strong analytical and presentation skills.
    • Excellent written and oral communication skills.
    • Detail-oriented, conscientious and extremely well organized.
    • Ability to exercise considerable judgment, maintain confidentiality, and act in a diplomatic manner.
    • Ability to manage multiple competing priorities.
    • Ability to work extended hours, weekends, and holidays pursuant to industry demands.
    • Willingness to travel.Additional InformationWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Lawrence , Remediation Project Manager (REF10620T), Executive , Lawrence, Kansas

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