Experience

ECLEVAR

• France
• Medical Device
• 1 - 100 Employee

• Medical Writing Director

  • Sep 2022 - Present



NAMSA

• Principal Medical Research Scientist, Regulatory

  • Nov 2016 - Sep 2022

• Principal Medical Research Scientist

  • Nov 2016 - Sep 2022



Pharmaceuticals and Medical Devices

• Hamburg und Umgebung, Deutschland

• Clinical and Regulatory Affairs Expert

  • Oct 2016 - Oct 2016



Bayer AG

• Berlin und Umgebung, Deutschland

• Clinical Trial Coordinator

  • Mar 2016 - Oct 2016



Waldemar Link GmbH & Co. KG

• Germany
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Clinical Affairs Manager

  • Sep 2012 - Sep 2016

  • Medical writing - Preparation of the Clinical Evaluation Reports for class 2a, class 2b and class 3 medical devices according to MDD 93/42/EC and MEDDEV 2.7.1 • Performing of the literature search, screening and identifying of all relevant scientific literature • Responsible for creating clinical strategy, planning and management of all LINK products including clinical studies related management of contracted organizations conducting studies in foreign countries (IITs studies) • In collaboration with the Marketing, negotiate and administer all activities with Contract Research Organizations concerning contracts and activities including adherence to SOPs, protocols, and medical evaluation according to parameters of each trial • Managing together with outside legal counsel the completion all clinical aspects of PMA, IND, and/or 510K regulatory applications coupled with international regulatory submissions to appropriate agencies inclusive of CE mark application. Participate in clinical development activities and strategies • Design of clinical trial with Clinical Research Organizations (CRO). Monitor and analyze clinical trial data and direct the disposition of results • Perform site initiations, monitoring visits, close out visits as required • Responsible for device clinical trial activities and reporting of any and all clinical data in regards to regulatory compliance



UT Southwestern Medical Center

• Dallas, Texas, Vereinigte Staaten

• Scientist

  • Apr 2012 - Jul 2012

  - Develop or provide protocols, guidelines, implementation plans (FDA, GCP Regulation) - Participate in studies with single or dual modalities, timelines and study specific deliverables, facilitates regular meetings with the sponsor and study team and implementation of clinical study - Several Seminars und Presentations - Develop or provide protocols, guidelines, implementation plans (FDA, GCP Regulation) - Participate in studies with single or dual modalities, timelines and study specific deliverables, facilitates regular meetings with the sponsor and study team and implementation of clinical study - Several Seminars und Presentations



CRS Kiel

• Kiel

• Clinical Project Manager

  • Mar 2008 - Dec 2011

  •Develops and oversees study operations plan(s) •Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials •Participates in study data review and assists with patient narrative writing and other data review activities as assigned •Internal training courses and Presentations (GCP, AMG, EKG, Diabetes Mellitus, AIDS, Tumors) •Develops and oversees study operations plan(s) •Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials •Participates in study data review and assists with patient narrative writing and other data review activities as assigned •Internal training courses and Presentations (GCP, AMG, EKG, Diabetes Mellitus, AIDS, Tumors)



Training Academy

• New Zealand
• Education Administration Programs
• 1 - 100 Employee

• Management Trainee

  • 2007 - 2008

  •Marketing, Project management, Public Relations, Accounting system, Company management Personnel, Technique of Management •Marketing, Project management, Public Relations, Accounting system, Company management Personnel, Technique of Management



Nursing Station

• Nurses

  • 2001 - 2007

  Temporary employment Documentation, Planing and Coordinating Temporary employment Documentation, Planing and Coordinating



Institute for Medical Genetic of Berlin

• Berlin

• Research Assistance

  • Jan 2006 - Oct 2006

  •Molecular Biological - Methods •Functional role and mutants Production of ANK - Protein (progressive ankylosis •Molecular Biological - Methods •Functional role and mutants Production of ANK - Protein (progressive ankylosis



Medical University of Dusseldorf

• Scientific staff

  • May 1999 - Nov 2000

  Medical University of Dusseldorf •Metabolism and Gastrointestinal Disorders •Presentation on Diabetes Mellitus I and II Medical University of Dusseldorf •Metabolism and Gastrointestinal Disorders •Presentation on Diabetes Mellitus I and II