Posted to MedZilla on 8/20/2017


ProClinical

England, Medical Director (EMEA/APAC) - Remote based ME_KH_12917-MZ


 
 

ProClinical is seeking a Medical Director (remote based) for a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. With offices in 46 countries and more than 15,000 professionals worldwide, this global CRO applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Job Overview:

  • Provides medical review and analysis of pre-approval serious adverse events, post-approval ICSR and
  • periodic safety reports as well as other client deliverables (labelling reconciliation documents, CTD
  • modules, REMS, RMP and CSR) to ensure company SOPs, client directives, and regulatory requirements
  • are followed. Other responsibilities may include attending and presenting at investigator and sponsor
  • meetings, providing medical consultation to clients, investigators and project team members and support
  • business development activities. Medical Directors also serve as mentors to PVG colleagues.

Skills and Requirements:

  • MD degree or equivalent
  • Active medical licensure (preferably in country of residence)
  • Several years of relevant experience such as pharmaceutical industry or CRO, in clinical development or pharmacovigilance or significant clinical trial experience as a principal investigator, and experience treating patients in a clinical setting.
  • Fluent in spoken and written English
  • Fluent in spoken and written English
  • Strong medical knowledge
  • Strong analytical skills
  • Strong negotiating and influencing skills
  • Reliable and self-motivated
  • Excellent oral and written communication skills
  • Excellent interpersonal and team building skills
  • Ability to work independently, analyse and work with attention to detail, process and prioritize sensitive complex information, and problem solve
  • Ability to exercise creativity and judgment
  • Expert knowledge regulations governing adverse event reporting
  • Understanding guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
  • Assertive in sponsor discussions
  • Understanding biostatistics, data management, and clinical operations procedures
  • User level computer application knowledge (Microsoft Word, Excel, PowerPoint, Adobe Acrobat, etc.)
  • Ability to mentor effectively on global medical processes in both one-on-one and in group settings.
  • Overall knowledge of the drug development process

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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