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Project Manager Medical Devices

X4 Group
Job LocationCambridge
EducationNot Mentioned
Salary£50,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Project Manager needed to join a Medical Device company I am working with based in Cambridge. This is an exciting and unique opportunity to join a highly energized medical devices technology company at a strategic inflection stage with near-term evolution into a full delivery turn-key operation in providing auto-injector device development alongside GMP facility fill & finish capabilities. There is exceptional scope to develop and influence company success and benefit directly from the opportunity.Job purpose

  • To act as the strategic and operational champion, and team orchestrator, in leading across a matrix of technical experts in developing and delivering drug / device combination medical autoinjectors to appropriate medical device standards.
  • To take overall responsibility for the coordination of successful initiation, planning, execution, monitoring, controlling and closure of projects.
  • To ensure that projects proceed in a state of control and complete within the agreed time frame, quality, budget and scope.
  • To take ownership of project communications, driving internal / external engagement and collaboration with stakeholders and clients.
    • Key Responsibilities
  • Responsible for the scoping, planning, executing, monitoring & control of project plans for customers ensuring that detailed activities are suitably, realistically and accurately forecasted for resource and timelines.
  • In partnership with the matrix team, develop, implement and maintain the project plan as accurate. Orchestrate and champion plan progression with delivery risks identified and mitigation plans in pace to mitigate delays, scope change or cost increases.
  • Pre-empt development activity requirements and champion their planning and delivery.
  • Evaluate, highlight and escalate unresolved issues or potential barriers to project progression, representing the voice of the customer where appropriate.
  • Be the “grease and the glue” of the project team, facilitating the operational conduct and development tasks and forming the cohesive bond between functional team representatives.
  • Design and deliver management update reports focussing on near-term critical path activities and requirements for achievement and delivery of milestones.
  • Maintain the strategic alignment of projects by focussing activities and operational delivery on critical path and challenging the internal team on necessary decisions to keep delivery on track within approved budgetary / resource parameters.
  • Utilise appropriate project management methods and standards, implementation of good project management practice, and soft skills for team collaboration, motivation and efficient performance.
  • Demonstrate a solid comprehension of client requirements in controlling operational delivery, stakeholder communications and scope emphasis.
  • Ensure project associated documentation are completed and maintained to required standards; quality of technical files and regulatory dossier associated documentation is to required standards and supports license approvals.
  • Manage the interface with suppliers including CMOs, CROs and regulatory consultants to ensure that the scope of work is appropriate to meet the project objectives, is clearly communicated and timelines for deliverables are met. Ensure that internal requirements are clear and championed to prevent deliverable delays.
  • As appropriate, partner with Business Development in the consideration and development of proposals for new business, and external company due diligence.
    • Personal characteristics
  • Self motivated and proactive nature
  • Demonstrates leadership qualities
  • Thrives in an open and less structured environment of a young technology company
  • Open, honest, inclusive, personable
  • A team player with good interpersonal and communication skills
  • Willingness to Travel
  • Resourcefulness
  • Smart appearance and highly professional manner
    • Experience/Skills Essential
  • 5 - 10 years’ experience at project manager level or above in a drug development or industrialisation role within the Pharma R&D or Medical Device Industry
  • Experience in project management of pharmaceutical drug development programmes including formulation and clinical trials to regulatory approval, and close partnership with major functions within the industry (commercial, R&D, IP, legal, finance)
  • Degree qualification in a science or technology subject
  • Comprehension of, or accreditation within, a Project Management training environment (eg PMI PMBOK, PRINCE2, APM, PMP)
  • Strong written and verbal communication skills
  • Strong planning skills
  • Strong analytical and problem solving skills
  • Strong IT user skills
  • Ability to undertake risk analysis and of risk management
  • Experience of dealing with suppliers and customers at a technical level
  • Good presentation skills
    • Desirable
  • Experience in management of drug device combination projects
  • Experience in sterile product development / manufacture
  • Experienced in master validation planning and execution
    • Please get in touch with Robbie Knight at if you think you could be a suitable fit for this position.

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