Led internal audits and quality improvement initiatives, identifying compliance gaps and implementing corrective measures in outpatient settings.
Developed and enforced healthcare compliance protocols, ensuring alignment with CMS Star Ratings, Leapfrog, NHSN, and other quality metrics.
Provided data evaluation and analytics to interpret performance metrics, supporting strategic decision-making and regulatory submissions.
Collaborated with clinical teams to enhance patient safety protocols, ensuring compliance with HIPAA, FDA regulations, and other healthcare standards.
BIOPHARMACEUTICAL STRATEGY AND OPERATIONS INTERN
Pharmacompany (Gore and Company)
Boston, MA
03.2024 - 05.2024
Conducted analysis of clinical trial data using advanced statistical methods and visualization techniques to support regulatory submissions
Collaborated closely with regulatory affairs teams to align analytical insights with regulatory requirements and strategic business objectives
Presented findings and recommendations to stakeholders, enhancing regulatory strategy development and decision-making processes
REGULATORY AFFAIRS AND STRATEGY INTERN
Takeda Pharmaceuticals
Cambridge, MA
07.2023 - 09.2023
Conducted in-depth analysis of clinical trial data, aligning findings with regulatory requirements to support FDA submissions.
Collaborated with regulatory affairs teams to develop compliance strategies that met CMS Star Ratings, Leapfrog, and NDNQI standards.
Presented analytical insights to stakeholders, contributing to the strategic direction of regulatory initiatives.
Additional Experience: CO-DIRECTOR
SRC Dance Studio
Aldie, VA
02.2018 - 12.2022
Managed all aspects of studio operations, including customer service, staff training, and compliance with safety regulations.
Developed and implemented marketing strategies to increase enrollment, enhancing the studio's reputation and financial performance.
Led initiatives to improve the customer experience, resulting in increased satisfaction and retention rates.
POST MARKET SAFETY AND COMPLIANCE INTERN
Takeda Pharmaceuticals
Cambridge, MA
05.2022 - 09.2022
Supported the development of study protocols and SOPs in accordance with GCP and FDA guidelines, ensuring rigorous compliance.
Facilitated communication between regulatory and clinical teams, addressing challenges to maintain study integrity and regulatory compliance.
Managed adverse event reporting, ensuring accurate documentation and adherence to healthcare regulatory standards.
RX ASSOCIATE
CVS Healthcare
South Riding, VA, And Boston, MA
04.2019 - 06.2020
Managed outpatient pharmacy operations, ensuring compliance with CMS and FDA guidelines while delivering exceptional patient and customer service.
Conducted training sessions for pharmacy staff on healthcare regulations, customer service best practices, and patient engagement techniques.
Developed and implemented strategies to improve patient satisfaction, aligning with CMS Star Ratings and HCAHPS metrics.
Led initiatives to optimize workflow efficiency and enhance compliance with regulatory requirements, resulting in improved patient outcomes.
ASSISTANT CLINICAL TRIAL MANAGER
Cape Coast Teaching Hospital
Ghana, Africa (Remote)
05.2019 - 05.2020
Led the development and execution of comprehensive marketing strategies, aligning business objectives with actionable plans to drive organizational growth
Established key planning artifacts and delivery roadmaps, ensuring progress tracking and strategic decision-making support across cross-functional teams
Supported senior leadership in producing essential planning materials and facilitating alignment across the organization, enhancing operational efficiency and effectiveness
Additional Experience: PATIENT CARE ASSISTANCE
INOVA
Alexandria, VA
07.2016 - 09.2018
Assisted in creating a positive environment for patients, family members, and staff by providing excellent customer service.
Maintained accurate records of all patient care activities using electronic health record systems.
Collaborated with multidisciplinary teams in order to provide comprehensive patient centered care.
Education
Doctor of Pharmacy (PharmD) -
Massachusetts College of Pharmacy
Bachelors - Pharmaceutical Sciences
Massachusetts College of Pharmacy
Skills
Presentation and Communication Excellence
Medical Writing and Document Quality Assurance
Compliance and Risk Mitigation Procedure development
Project Management
Efficient SOP/GCP/ICH/ FDA Regulatory submission knowledge
Knowledge of Huron Group Principles of Patient Engagement
Strategic Planning and Execution
Clinical Trial Management
Operations Management and Optimization
Data Analysis and Insights Generation
Proficiency in Microsoft Suite (Excel, Powerpoint , Teams, etc)
Quality Improvement Initiatives Development & Implementation
Data Evaluation & Analytics for Healthcare Quality Metrics
Strategic Planning & Execution in Clinical and Outpatient Settings
Patient Experience Enhancement & Customer Service Excellence
Team Leadership & Staff Training
Certification
Six Sigma Green Belt Certification (2024 Candidate)
Medical Affairs Competency Certification (MACC), includes certification in Compliance, Regulatory Affairs, Drug Development process, and Clinical Trials
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