MF Malaysia: Clinical Research Unit Manager (Penang-based)

Clinical Research Physician
  • TypeFull Time
  • SectorClinical Research
  • SeniorityManagerial
  • LocationMalaysia
  • RoleMedical Officer

The company

One of Malaysia’s leading pharmaceutical manufacturing company with the focus of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally.

 

The Job

Overall ownership of clinical studies for the organization including effective management of research projects studies. Some key areas:

 

  • Management of all clinical sites from start up to close-out
  • Lead the Clinical Research Unit team to achieve key performances
  • Work on Management proposals for new projects by conducting scientific and feasibility review of new projects
  • Plan, manage and review research projects’ execution to ensure they are within approved budget, resources & timeline
  • Develop new study protocols, research proposals, research budget and to review projects for cost impact and risks for unplanned deviations
  • Prepare and manage submissions for the EC (Ethics) and RA (MOH/Country) submissions
  • Manage and follow up IND submissions, Orphan Drug applications and maintenance of regulatory and ethics approval
  • Identify, collaborate and manage project progress with external contract research organization, collaborators and project managers to new project start-ups and support research project for product development
  • Internal collaboration including agreements review with Legal Department, study documents and drug dossier with Regulatory Affairs, drug safety issues with Clinical Research Physician and new research findings and technical responses to support Marketing team on products of interest
  • External collaboration with regulatory consultants e.g USA agents and EU representatives
  • Manage external stakeholder communications for international studies (CRO or collaborators)
  • Attend meetings to secure successful regulatory applications such as Orphan Drug Designation and Pre-IND meetings with US FDA

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