Clinical Research - Head of Gastroenterology II (m/f/d)
Clinical Research - Head of Gastroenterology II (m/f/d)
Dr. Falk Pharma GmbH
Freiburg im Breisgau
Teilweise Home-Office
Schnelle Bewerbung
Participation in reviewing the clinical sections of regulatory submission dossiers, documents for scientific consultations (e.g., Scientific Advice, PIP, benefit dossier, etc.), or orphan drug applications in consultation with the Head of Clinical Research * Participation in coordinating and drafting responses to clinical deficiency letters in regulatory procedures in consultation with the Head of Clinical Research * Solid knowledge of regulatory requirements for conducting clinical trials * Several years of management experience - As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis.
Participation in reviewing the clinical sections of regulatory submission dossiers, documents for scientific consultations (e.g., Scientific Advice, PIP, benefit dossier, etc.), or orphan drug applications in consultation with the Head of Clinical Research * Participation in coordinating and drafting responses to clinical deficiency letters in regulatory procedures in consultation with the Head of Clinical Research * Solid knowledge of regulatory requirements for conducting clinical trials * Several years of management experience - As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis.