Our customer is an ambitious, independent service provider in pharmaceutical development, international regulatory affairs and drug licensing located in Southern Germany between Basel and Freiburg. The clients are pharmaceutical and biopharmaceutical companies of all sizes from Europe and abroad. Our customer is highly committed to the success of his clients, and works to highest quality standards. To further strengthen his Medical Team, we are now searching exclusively for a senior medical expert with regulatory and development expertise.
The Medical & Preclinical Team is an international group of experienced professionals, trained in clinical and veterinary medicine, in biology and pharmaceutical sciences. Extensive practical and scientific experience in academia, industry and clinical medicine makes this team a competent partner for making our client´s development projects successful. Their mission is to develop a tailor-made way forward for each individual project throughout the preclinical, clinical, and authorization stages of development.
As a senior medical expert you will support our clients in a wide range of clinical development activities. As a member of our Medical and Preclinical Team, you will be responsible for pharmaceutical and biopharmaceutical projects in different therapeutic areas and different phases of development. Amongst others you will be involved in processes such as:
Regulatory and clinical development planning
Scientific Advice procedures
Consultation with regulatory authorities
Preparation of CTD and Product Information
Answering questions of authorities to submitted documents
Conducting systematic literature searches
Feasibility Assessment and Due Diligence for In-Licensing candidates
Clinical Trial planning and management, evaluation and interpretation of results
We´re looking for a senior medical expert, preferably a physician, with specific expertise in development of medicinal products
Experience in clinical trials Phase I to IV (academia, industry, CRO) and/or writing documents needed for regulatory purposes
Qualification in Pharmaceutical Medicine and/or experience in Clinical R&D or Regulatory Affairs
Be part of a high class and independent regulatory Affairs Consultancy with a nice Team and a great infrastructure.
Moritz von der Brelie
Senior Manager Business Development Schweiz