Bianca Hajek

Dynamic and knowledgeable healthcare professional with extensive experience in pharmacy practice, regulatory compliance, and clinical research. Proven expertise in communicating complex clinical concepts, medical terminology, and safety protocols to diverse audiences with empathy and clarity. Brings a strong foundation in patient and staff education, detailed documentation, and industry standards.

Holds an M.S. in Regulatory Affairs & Health Policy, a B.A. in Psychology, and active PTCB certification, with a strong commitment to mentoring and shaping future healthcare professionals.

Regulatory Compliance Coordinator (Clinical Protocol Data Management) at Atlantic Health System (2025-04 – Present)

Manage regulatory submissions and documentation throughout the life cycle of clinical studies, ensuring compliance with FDA, IRB, GCP, and institutional standards. Serve as liaison between investigators, sponsors, and regulatory bodies. Maintain audit-ready records and promote best practices in healthcare documentation and compliance.

Pharmacy Technician / Regulatory & Compliance Specialist at Life Science Pharmacy (2018-04 – 2025-04)

Designed and delivered comprehensive staff training programs, onboarding new hires and mentoring team members on clinical workflows, and safe medication handling. Enforced rigorous, continuous compliance with USP standards, state boards, and federal regulations across all pharmacy operations, compounding processes, and documentation. Partnered directly with pharmacists to oversee daily operations, optimize workflow efficiency, manage inventory control, and ensure accurate record-keeping.

Pharmacy Technician / Regulatory & Compliance Specialist (Per Diem) at Life Science Pharmacy (2025-04 – Present)

Administrative Assistant at Life Science Pharmacy (2014-06 – 2018-04)

Supported pharmacy operations through scheduling, documentation, and patient communication while developing strong organizational and interpersonal skills.

Master of Science in Regulatory Affairs & Health Policy – Massachusetts College of Pharmacy and Health Sciences (2022)

Certificate in Public Health Fundamentals and Principles – University at Albany (2020)

Bachelor of Arts in Psychology – Russell Sage College (2017)