R&D Project Manager
Lean way of Managing Workforce
Athens, Attica, Greece
πριν από 5 μέρες

Description

lmw is seeking an R&D Project Manager on behalf of a generic manufacturing company based in Athens.

Responsibilities

  • Manage CMC activities for assigned projects at all stages of R&D.
  • Establish strategies that meet project and regulatory requirements.
  • Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers.
  • Liaise with service providers to monitor progress against milestones, as well as resolve technical, quality or resource issues smoothly.
  • Review and manage technical data and documentation to ensure timely action, compliant storage and efficient retrieval.
  • Prepare project updates, presentations and reports for both internal and external stakeholders.
  • Prepare regulatory documentation (non-clinical and quality modules) and support regulatory submissions.
  • In collaboration with Procurement, identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness.
  • Organize quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list.
  • Support the development, implementation, maintenance and monitoring of quality systems to ensure compliance with GLP, GMP and GDP requirements.
  • Manage standard operating procedures relating to pharmaceutical quality.
  • Requirements

  • 3+ years of experience in an R&D department
  • Bachelor's Degree in Chemistry, Pharmacy or relevant, a post graduate degree will be highly valued
  • Robust knowledge of non-clinical safety studies, CMC activities, and regulatory requirements
  • Expertise in project management within a multi disciplinary R&D environment
  • Experience in managing international relationships with external project partners and service providers
  • Fluency in English
  • Expert use of MS Suite, as well as a planning software
  • Availability to travel abroad when required
  • Benefits

    The company offers an international standards work environment with real opportunities for career development.

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