Medical Director (Rheumatology) in Germany

Job Title: Medical Director (Rheumatology)

Overview:
Our client, a leading global contract research organisation provides comprehensive, integrated drug development, laboratory and life cycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. With offices in 46 countries and more than 15,000 professionals worldwide, they apply 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.

Basic Purpose and Objective:
The Medical Director 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:
* 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 prioritise sensitive complex information, and problem solve
* Ability to exercise creativity and judgement
* Expert knowledge regulations governing adverse event reporting
* Understanding guidelines for marketing authorisation submissions and international guidelines for conduct of clinical studies
* Assertive in sponsor discussions
* Understanding bio-statistics, data management, and clinical operations' procedures
* User level computer application knowledge (Microsoft Word, Excel, PowerPoint, Adobe Acrobat, etc.)

Location: Fully remote; home based from any location across the EU.

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.