Silke Schwarz Email and Phone Number

I am highly motivated, targeted and innovative scientist with strong interest in Clinical Research, Quality Assurance and Regulatory Affairs (medical device and drug approval and national and european marketing authorization procedures). Based on my previous professional experience with more than 14 years of extensive research experience as well as more than 10 years as head of laboratory, and professional training at Pharmaakademie GmbH & Co KG as CRA, I am convinced that I can make a valuable contribution toward reaching your companies goals. Some of my qualifications, experiences and interests I point out here:• EU regulations, directives, guidelines (AMG, 726/2004, ICH- GCP, GCP, GMP, Declaration of Helsinki, RL 2001/83/EG)• Medical devices: MPG, MSPV, RL 93/42/EWG und RL 90/385/EWG; MDR 2017/745/EU• DIN EN ISO 13485 / 14155 / 14971• Authorization/ Approval of medicinal products for human as well as veterinary medicine• Generation and handling of essential documents (TMF, ISF, ICF, CRF, IB, study plan, CTD and IMPD)• QA/QC (SOP´s, audits and inspections)• Pharmacovigilance reporting obligations (AE, sAE, SUSARs)• Project management• Handling of IMP• Clinical study design, Monitoring of clinical trials• Submissions for ethics committees and federal agencies as well as local authorities• Data management, biometric basics, evaluation of clinical trials, statistics• Healthcare management and economicsSince the focus of my research was on implant materials developed as Class III non-active medical devices, Regenerative Medicine and Tissue Engineering, I am also familiar with• Conducting internal audits• Document processing and production (SOP´s)• Submissions for ethics committees and local authorities• Biological envaluation of replacement matrices: DIN EN ISO 10993 and DIN EN ISO 11737-1• Tissue engineering procedures of cartilage, bone and tendonsBesides this, I have excellent verbal and written communication skills and I am highly experienced in maintenance of contact to and between collaborators. I have a well developed expertise in supervision and training/teaching of students, scientific, medical and non-medical staff. As a driven researcher engaged in accurate and detail-oriented handling of scientific data, I am adept in data evaluation and scientific writing. My strengths include effective time management, strong interpersonal, social and team-oriented skills and characterize me.