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Skills

  • Payroll and budgeting
  • Spreadsheet management
  • Meeting arrangements
  • Document conversion
  • Customer and client relations
  • Sorting and labeling
  • Appointment setting
  • Customer relations and communications
  • Business correspondence
  • Report development

Work Experiences

  • Handled phone and email correspondence, made copies, and handled incoming and outgoing mail and faxes as part of my administrative duties.
  • Discovered new sources for office supplies and kept a close eye on inventory usage to save $12.
  • Transcribed and organized information to aid in the preparation of speeches and presentations.
  • Wrote professional memos, letters, and marketing copy to support business objectives and growth.
  • Identified and suggested improvements to existing processes in order to improve accuracy, efficiency, and service quality.
  • Kept track of office supplies by checking inventory and ordering new supplies as needed.
  • Was in charge of accounts receivable, which included invoicing, investigating chargebacks, discrepancies, and reconciliations.
  • Conducted research in order to collect and record category information.
  • Oversaw complex and detailed projects for executives, ensuring that budgets were met and projects were delivered on time.
  • Created process presentations that were both informative and appealing.

Summaries

  • Agendas are well-prepared, meetings are well-scheduled, and action items are followed up on.
  • Client relations and cross-functional collaboration are examples of areas of expertise.
  • Administrative professional with strong communication, planning, and prioritization skills demonstrated over 5 years of service.
  • Offering 14 years of experience in customer relations management.
  • Calendar management, scheduling, data entry, and database administration are all areas where she shines.
  • Experienced in scheduling and coordinating meetings, managing travel and expense reports, and transcribing minutes.
  • Dedicated team member with excellent organizational skills and a keen eye for detail.
  • Manages multiple projects at the same time with a high level of accuracy.
  • For initiative, a detail-oriented Records Specialist capable of coordinating digital and physical records.
  • Expert at locating and resolving inconsistencies.

Accomplishments

  • Assisted in successfully filing 16 New Drug Applications (NDAs), facilitating timely review by framework and securing approval for Salesforce.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Processed over 10 variations and amendments in metric resulting in quicker market access for Asana and a record delivery time of 17 days.
  • Collaborated with cross-functional teams to update over 14 Standard Operating Procedures (SOPs) that enhanced overall regulatory compliance across the company.
  • Proofread, formatted, and submitted regulatory dossiers to initiative, ensuring compliance with the latest guidelines and reducing submission rejection rate by 52%.
  • Managed and organized regulatory documentation through Tableau, ensuring submission of accurate files by strict deadlines, reducing error rate by 48%.
  • Coordinated the submission of 7 investigational new drug applications (INDs) through the eCTD gateway, reducing approval times by 27%.
  • Implemented new electronic document workflows, resulting in improved submission traceability and a 38% increase in regulatory document approval speed.
  • Served as the regulatory coordinator for 8 global Health Authority audits, achieving positive closure with zero critical findings.
  • Tracked and monitored regulatory timelines for Jira, enabling the department to adhere to 83% of required deadlines ahead of schedule.

Affiliations

  • International Society for Pharmaceutical Engineering (ISPE)
  • Rotary International
  • Regulatory Affairs Professionals Society (RAPS)
  • American Society of Safety Professionals
  • Member, Council for International Organizations of Medical Sciences (CIOMS)
  • Association of Information Technology Professionals
  • National Organization for Rare Disorders (NORD)
  • Affiliate, International Society for Regulatory Toxicology and Pharmacology (ISRTP)
  • Association for Computing Machinery
  • Freemason

Certifications

  • Microsoft Certified Systems Engineer (MCSE)
  • Regulatory Affairs Certification (RAC) - Global Scope
  • Certified Information Systems Auditor (CISA) for Compliance Roles
  • CompTIA A+ Technician
  • Project Management Professional (PMP)
  • Certified Quality Improvement Associate (CQIA)
  • Fundamentals of FDA Regulatory Affairs Certificate
  • Drug Development and Regulatory Affairs Certification (DD&RAC)
  • Certified Compliance and Regulatory Professional (CCRP)
  • Salesforce

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