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Program Manager

RaleighMerz North America



The Program Manager will lead programs within the Merz strategic areas of focus (Neuroscience and Aesthetics). This responsibility will require strong project management skills. The Program Manager will lead Research and Development programs of drug/biologic/medical device/consumer products, with emphasis on Class 2 and Class 3 medical devices, by establishing and leading an effective multidisciplinary project team in order to meet program goals.
  • Facilitate the project team to identify and execute an efficient development plan containing activities which will successfully meet the desired product profile and that will support the required regulatory submission(s)
  • Draw upon medical device, consumer product, and/or drug development skills and experience to effectively drive product development
  • Develop and maintain documentation inclusive of, but not limited to, agendas, decisions/actions, design control documents, design history files, plans, presentations to governing committees, project charters, status reports, and timelines for assigned projects
  • Manage project budgets, including quarterly forecasting and monthly accruals
  • Identify, with the project team, potential line extensions for currently marketed products and provide project management input into potential acquisitions as requested
  • Communicate project status and information to international and local management teams
  • Effectively facilitate the identification of program risks and mitigation strategies, resolution of issues and removal of barriers to progress the product development activities
  • Assist with the contracting process for outsourced activities in collaboration with the corresponding functional team members
  • Participate in regulatory agencies meetings and submissions as requested
  • May act as the key contact person and interface to internal/external customers
  • May participate in multidisciplinary task forces for ongoing development and/or refining of processes



Requirements:
  • Bachelor’s degree in science, engineering, or health care discipline
  • Demonstrated project management ability in coordinating multi-disciplinary team to deliver projects within timelines and budget
  • Working knowledge of the regulatory requirements as they pertain to product development and clinical trials (e.g. cGCP, GMP, design control, risk management)
  • Have demonstrated skills as a leader, motivator, and in conflict resolution and problem solving
  • Experience with Microsoft Project/Office
  • PMP certification is preferred



Requirements for Senior Program Manager:
  • At least 8 years of experience in medical device R&D product development including at least 5 years in the role of Project Manager
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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