Helena Daniels
Bismarck,ND
Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Experienced administrative professional knowledgeable about registrations, audits, inspections and other [Type] industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.
Overview
13
13
years of professional experience
Work History
Business and Regulatory Analyst
CHI ST. Alexius Health
01.2016 - 10.2024
- Responsible for developing and maintaining files for budgets, contracts, letters and mailings
- Creating budget templates, letters and mailings
- Completing fiscal management of accounts receivable/payable, deposits, cost accounting of expenses in reference to each study
- Creating reports as needed
- Reconciliation of payments and services back to invoices and contracts
- Quarterly and final audits of each study to no incoming or outgoing payments were misses
- Prepared and submitted regulatory file applications and supporting documentation.
- Organized and detail-oriented with a strong work ethic.
Research Assistant
CHI St. Alexius Health
01.2014 - 01.2016
- Responsible for front desk duties, answer phones, greet visitors, create letters, mailing and other duties as needed by office staff
- Worked directly with manager to review and edit contracts and budgets
- Monitored project timelines, ensuring timely completion of tasks while maintaining high-quality output.
Pharmacy Technician in Training
CHI St. Alexius Health
01.2012 - 01.2014
- Preparing medication orders for loading into medication distribution systems
- Checked inventory for medication outdates
- Organizing and replacing supplies
- Performed various pharmacy operational activities with strong commitment to accuracy, efficiency, and service quality.
- Demonstrated strong attention to detail in the accurate preparation of medication labels, ensuring clear instructions for patients and healthcare providers alike.
- Counted, measured and compounded medications following standard procedures.
Education
No Degree - Business Management
University of Mary
Bismarck, NDSkills
- Microsoft Office 365
- Compliance Monitoring
- Documentation Review
- Audit Coordination
- Payment Processing
- Communication Skills
- Data Entry
- Attention to Detail
- Multitasking
- Regulatory Submissions
- Relationship Building
Timeline
Business and Regulatory Analyst
CHI ST. Alexius Health
01.2016 - 10.2024
Research Assistant
CHI St. Alexius Health
01.2014 - 01.2016
Pharmacy Technician in Training
CHI St. Alexius Health
01.2012 - 01.2014
No Degree - Business Management
University of Mary
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