Job Title: Medical Director Endocrinologist EMEA
Location: Remote UK- EU BASED
Contract: 12M - freelance/umbrella
Hours: 40 hours per week - full time
Pay: 200-210EUR per hour
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 firstname.lastname@example.org 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.
Knowledge, Skills and Abilities:
- Must be board certified or equivalent in Endocrinology.
- Fluent in spoken and written English
- Strong medical knowledge
- Expert knowledge regulations governing adverse event reporting
- 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
- 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
80% Project Related Medical/Safety Support:
- Minimize potential risk to clients by managing all medical aspects of contracted tasks. This includes, but is not restricted to, the monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication per protocol restrictions and unblinding requests, etc.). Scope of work also includes discussion with principal investigators and clients of all medical concerns raised during a study by using proper medical judgment, interpretation and decision.
10% - Business Development:
- Present standard medical/safety processes to prospective clients at business development meetings, and communication with medical communities to explore and expand business. This includes participation in business development opportunities (e.g., networking) at educational conferences and meetings.
- Collaborate with bidders in establishing parameters for business deliverables.
- Participate in strategy calls, proposal development, feasibility activities and bid reviews.
10% - Business Administration:
- Contribute to PVG-Departmental initiatives, process improvements and training.
- Attend MD allocation calls, appropriate project billing, submitting expense reports, arranging travel for business in collaboration with company travel
- Carry cellular phone 24/7 for 24 hours a day coverage of assigned studies including weekend/afterhours calls from our answering service.
- Pursue continuing medical education credits as required to maintain active medical licensure.