• Applications for authorisations, significant variations, variations, renewals, notifications• Application of PSUR’s• Control of expert informations, patient informations and packaging components• Submissions for pricing and reimbursement• Batch release and quality assurance

CARDIOMETABOLIC CARE AND DERMATOLOGY• Business Development: Establishment and cultivation of contacts to key opinion leaders• Product specific medical training of the sales staff• Marketing Support, preparation of advertising and information material for medical experts• Customer information management, medical and scientific research responses• Presentor at scientific symposiums• Communication with Merck Corporate regarding medical-scientific interests• Investigational Set-up of Investigator Sponsored TrialsCARDIOMETABOLIC CARE, NEUROLOGY AND ONCOLOGY• Operational set-up of clinical trials phase II to phase IV in CH• Pharmacovigilance: Adverse reaction reporting

CLINICAL AND PRE-CLINICAL RESEARCH• Organizing and reviewing of expert reports and the completion of application dossiers• Drafting Investigator’s brochures• Designing and planning of phase I, phase II and phase III studies including consulting with internal experts, clinical research organizations (PD, PK, statistics, regulatory) and key opinion leaders in European Clinical Pharmacology, Dermatology, Neurology and Immunology• Drafting of clinical trial protocols and reviewing of clinical trial reports for regulatory submissions• Co-ordination and monitoring of key studies essential for regulatory submission• Co-ordination, planning, monitoring and evaluation of pre-clinical in-vitro and in-vivo functional assays in cooperation with several university clinics in Europe• Drafting Research and Secrecy Agreements including financial contracts in co-operation with the legal departmentCHEMICAL DEVELOPMENT / CHEMICAL MANUFACTURING CONTROL• Co-ordination and planning of validation of analytical methods and stability studies of active product ingredients and investigational drug products according to ICH-Guidelines• Control of chemical / pharmaceutical documentation for regulatory submission

• Post Marketing Authorization Applications: Notifications of changes• Up-date of expert and patient informations of registered drugs• Pharmacovigilance: CIOMS-Line-Listing and serious adverse event reportingCLINICAL AND PRE-CLINICAL RESEARCH• Co-ordination and monitoring of clinical studies• Co-ordination and monitoring of pre-clinical in-vitro and in-vivo functional assays in cooperation with several university clinics in EuropeCHEMICAL DEVELOPMENT / CHEMICAL MANUFACTURING CONTROL• Reviewing and control of batch documentation of active ingredients• Reviewing / control of batch documentation of medicinal drugs