Please note you must be able to work in the EU without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@ipharmconsulting.com or call UK: +44 (0)20 7551 0802 / EU: +31 20 809 0665.
i-pharm consulting is collaborating with a global contract research organisation concerned with providing comprehensive, integrated drug development, laboratory and lifecycle management services. Due to their continued growth, they are now looking to appoint a medical director specialising in Endocrinology an initial 12-month. Join them on their mission to enable their customers to make the world healthier, cleaner and safer.
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.
Education and Experience:
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.
Understanding guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
In-depth understanding of processes for medical monitoring services; ability to represent these processes at client meetings and identify any non-standard processes, and to identify any services out of the scope of the contract
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.