Kristi Covalciuc
Clinical Trial and Managed Access Leadership
- Role
- Associate Director Trial Delivery Leader, Medical Affairs, Managed Access at Johnson & Johnson Innovative Medicine
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
Experience
Associate Director Trial Delivery Leader, Medical Affairs, Managed Access
Johnson & Johnson Innovative Medicine
Jun 2022 — Present · Broomfield, CO, US
Leading the planning, execution and oversight of global managed access, pre-approval and post trial access programs with a focus on hematology and solid tumor therapeutic areas. US oversight for all cross-therapeutic pre-approval and post trial approval access programs.
Education
University of Colorado Anschutz
Public Health
1998 — 1999
Iowa State University
Bachelor of Science - BS, Biology
Skills
- Crf Design
- Ophthalmology
- Vaccines
- Gastroenterology
- Clinical Operations
- 21 Cfr Part 11
- Infectious Diseases
- Oncology
- Protocol
- Medical Devices
- Clinical Research
- Edc
- Therapeutic Areas
- Ich-Gcp
- Patient Recruitment
- Ctms
- Validation
- Regulatory Submissions
- Medical Writing
- Endocrinology
- Dermatology
- Immunology
- Clinical Development
- Cardiology
- Diabetes
- Asthma
- Clinical Data Management
- Oracle Clinical
- Pharmaceutical Industry
- Sop
- Fda
- Hypertension
- Pharmacovigilance
- Nutrition
- Biotechnology
- Neurology
- Drug Development
- Cancer
- Gcp
- Biopharmaceuticals
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