The Clinical Affairs Project Manager with minimal direction, the Medical Writing and Clinical PMS Project Manager manages activities of one or more Clinical project teams engaged in the design, implementation, and modification of projects that span across functional organizations. The PM ensures projects are completed on time and according to strict deadlines, within budget, and meet technical and scope requirements of the assignment. This includes coordinating the efforts of internal team members and third-party contractors or consultants in order to deliver projects according to plan. The Project Manager will also plan and oversee the project quality control throughout its life cycle. Requires professional expertise and interpersonal skills to manage multiple projects and interface positively with personnel from all company business units.

• Collaborates with all levels of stakeholders to establish objectives, timelines, milestones, and budgets for the global Clinical Medical Writing and Post Market Surveillance (MW & PMS) department.
• Establishes, communicates and tracks tasks necessary for successful project or program execution.
• Resolves issues and ensures task completion by establishing priorities and reaching compromise with team members and functional managers.
• Recommends project or program decisions, procedures, or policies to higher level management.
• Develops project plans and mechanisms for monitoring project progress and for intervention and problem solving as well as associated communication tools.
• Analyzes gathered data for decision making in conjunction with management.
• Supports the team members in the proper tracking of project activities.
• Reports out regularly on the status of projects, issues and mitigations.
• Develops and manages policies and procedures that affect project management.
• Where required, negotiate with other department managers for the acquisition of required personnel from within the company or external to ensure project tasks can be completed as planned.
• Identifies and resolve issues and conflicts within the project teams.
• Proactively and positively manages changes in project scope, identifies potential crises and device contingency plans.
• Coach, mentor, motivate and supervise MW&PMS project team members and contractors and influence them to take positive action and accountability for their assigned work.
• Supports the MW&PMS SMEs as needed during Audits.
• Maintains a calendar of Audits to be supported by the MW & PMS organization.
• Coordinates and drives timely MW&PMS actions resulting from Audits (NCs, CAPs, CAPAs and similar).
• Coordinates MW&PMS activities to meet Notified Bodies submissions as planned.
• Supports the team during NB Review question rounds, keeping Team Members motivated to perform and deliver according to high quality output expectations and strict turnaround timelines.

Your Background

• Requires a bachelor’s degree in Engineering or related field.
• Must have 5 years of experience in the position offered or related.
• Must have:
  • 5 years of experience with project management principles.
  • 5 years of experience with project management software.
  • 3 years of experience with medical device industry.
  • 2 years of experience with personnel management.
  • 2 years of experience with clinical studies practices and MDR regulation.

Travel Expectations

• Telecommuting / remote work permitted throughout the U.S.
• Role requires 10% domestic travel.