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Skills

  • Records management
  • Writing reports
  • Effective time management
  • Multi-line phone proficiency
  • Business correspondence
  • Office management
  • Workflow planning
  • Accounting familiarity
  • Documentation and control
  • Credit and collections

Work Experiences

  • Oversaw complex and detailed projects for executives, ensuring that budgets were met and projects were delivered on time.
  • Conducted extensive research using a variety of resources to assist professional staff with routine and special project tasks.
  • Took up to 13 calls per two years and quickly redirected them.
  • Answered a multi-line phone system and transferred callers to the appropriate department or staff member by 8 ring.
  • Wrote extremely precise internal and external letters and memos.
  • Used strategic planning and budget management to quickly resolve process issues, effectively reducing customer complaints by 14%.
  • Acted as a liaison between clients and vendors, maintaining open lines of communication.
  • Took and managed incoming and outgoing calls, as well as recording and distributing accurate messages to the office staff.
  • Created a new data management system that reduced data retrieval time by 7%.
  • Wrote internal memos and external correspondence for senior management and double-checked all paperwork for errors.

Summaries

  • Expert at locating and resolving inconsistencies.
  • With strong planning, problem-solving, and communication skills, I am extremely efficient and accurate.
  • Bringing 13 years of outstanding performance in related roles to the table.
  • Customer service and conflict resolution skills are excellent.
  • With 17 years of experience as Regulatory Affairs Administrative Assistant in Denver, I am organized and hardworking.
  • Astute Administrative Assistant focused on streamlining processes to improve data retrieval and storage, reduce physical storage requirements, and ensure the security of all data.
  • Administrative Assistant who is well-organized and dedicated and has a track record of providing excellent customer service in fast-paced environments.
  • Administrative professional with strong communication, planning, and prioritization skills demonstrated over 5 years of service.
  • Expert at multitasking in a fast-paced environment.
  • Drafting reports and business correspondence, managing mail, and updating tracking spreadsheets are all skills I possess.

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Participated in regulatory project planning, leading to the successful completion of 15 product submission plans ahead of 2019.
  • Resolved product issue through consumer testing.
  • Implemented new electronic document workflows, resulting in improved submission traceability and a 38% increase in regulatory document approval speed.
  • Reviewed and summarized key regulatory interactions, ensuring consistent follow-up, formal communication, and record keeping with framework to avoid compliance gaps.
  • Supported the lifecycle management of ServiceNow across multiple markets, tracking regulatory timelines and pivotal steps, ensuring compliance in the Southeast.
  • Collaborated with team of 6 in the development of framework.
  • Processed over 10 variations and amendments in metric resulting in quicker market access for Asana and a record delivery time of 17 days.
  • Assisted in the preparation of regulatory compliance documents associated with Good Manufacturing Practice (GMP) audits, leading to successful first-pass inspections in 2018.
  • Reduced inquiry response times by 64% by optimizing protocols for regulatory submissions and accelerating internal communication processes.

Affiliations

  • Clinical & Regulatory Affairs Alliance (CRAA) Networking
  • Society for Technical Communication (STC) – Regulatory Writing Focus
  • Member of the FDA Regulatory Affairs Stakeholder Forum
  • American Conference on Pharmaceuticals Compliance and Regulatory Affairs Attendee
  • Affiliate, International Society for Regulatory Toxicology and Pharmacology (ISRTP)
  • Project Management Institute
  • Institute of Validation Technology (IVT) Network
  • Society of Human Resource Management
  • International Compliance Professionals Association (ICPA)
  • Association for Supply Chain Management (APICS)

Certifications

  • Certified Quality Management System (CQMS)
  • Regulatory Affairs Certification (RAC) - EU
  • Certificate in Records Management (RecMgt)
  • Certified Information Professional (CIP)
  • Cisco Certified Network Associate (CCNA)
  • Certified Compliance and Regulatory Professional (CCRP)
  • Certified Quality Auditor (CQA) - Specific to Regulatory Submissions
  • Certified International Regulatory Professional (CIRP)
  • Certified in Regulatory Affairs (RAC) - US
  • Certified Document Controller (CDC)

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