R&D Project Manager (Information Technology)

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics

A Brief Summary

As a R&D Project Manager, you'll play a pivotal role in bringing new products to the market to make a positive impact on our customers – to make them live better, feel better and look better. The Project Manager reports to the Head of Injectables Project Management-US and works within our Project Management team in Raleigh, North Carolina.  This person will lead and support new/ongoing development projects, towards achieving the project milestones while ensuring the work meets Design Control requirements. The role requires excellent Project Management skills, a good understanding of Design Control procedures/requirements, and close collaboration with other cross functional teams (Product Development, Tech Transfer, Clinical Science & Operations, Regulatory Affairs, Quality, Product Safety, Marketing, and Medical Affairs) within Merz, external suppliers and consulting partners.  The ideal candidate will have a thorough understanding of Project Management practices, principles, and tools for medical device projects.  In addition, the candidate should have strong problem solving and communication skills with the drive and hands-on leadership qualities needed to deliver on challenging project goals.

Essential Duties and Responsibilities

• Project Planning:
  • Effectively lead, guide, manage, and mentor a team of internal and external cross functional resources to deliver the set project milestones to support the required regulatory submissions.
  • Responsible for the planning and coordination of all project team activities, translating strategy into cross-functional integrated project plans.
  • Prioritize the project tasks by identifying the critical path, remove any obstacles or barriers, resolve issues or conflicts to progress the project.
• Budget Management: 
  • Define, monitor, and manage project budgets, including quarterly forecasting and monthly budget reporting.
  • Assist, as needed, the respective functional team member with contracting process for outsourced activities including review and approval of the contract as necessary according to the approved project budget.
• Risk Management:
  • Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies.
• Resource Management:
  • Manage resources within a project team, when needed, negotiate with respective functional groups for the acquisition of required personnel for the project.
• Communication:
  • Facilitate project team meetings, set agendas, publish meeting minutes, follow-up on action items, and maintain required project documentation.
  • Develop presentations and communicate project status against key project milestones and budget for a broad set of stakeholders
• Other Task:
  • Lead ad-hoc projects and/or multidisciplinary task forces for ongoing development and/or refining of processes as needed.
  • Motivate and mentor the team to achieve set project objectives. 

Job Related Qualifications / Skills

Professional Experience

• Required: 
  • At least 5 years of experience in pharma, medical device product development
  • At least 2 years of experience in the role of Project Manager/Leader of cross-functional projects

Knowledge, Skills, and Abilities

• required:

  • Thorough understanding of Project Management practices, principles, and tools for medical device/drug/consumer product development projects

  • Good experience with Design Control, ISO 13485, ISO 14971 and other applicable standards

  •  project management skills in leading multi-disciplinary, multi-regional teams to meet project goals

  • Knowledge across the entire product development process from concept phase through design and development, design transfer, regulatory submission and approval, and launch

  • Expert knowledge of MS Excel, Outlook, PowerPoint, Word and proficient in MS Project

  • Proven experience managing multiple projects and/or programs concurrently

  • Demonstrate strong interpersonal, leadership, self-starting, oral/written communication skills
  • Demonstrate advanced skills as a team leader, motivator, and in conflict resolution
• Preferred:
  • Good working knowledge of regulatory filing requirements as they pertain to medical device product development
  • Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
  • Demonstrated ability to monitor, manage, and grow diverse external partnerships (CMO management)
  • Professional Project Management related certification (PMP, IPMA, or similar)

Education

• Required:
  • Minimum Bachelor's degree in scientific, engineering, or health care discipline
• Preferred:
  • Advanced degree in scientific, engineering, or health care discipline or MBA

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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. 41 CFR 60-1.35(c) Research and Development