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Skills

  • Drug product lifecycle management
  • Clinical trial optimization
  • Budgets
  • Relationship development
  • Process improvement
  • Adverse event reporting expertise
  • Project organization
  • Due diligence for M&A in pharmaceutical sector
  • Initiative equipment
  • Marketing understanding

Work Experiences

  • Advised on post-market surveillance systems.
  • Schedule appointments with potential and current customers to promote new products and services.
  • Collaborated with cross-functional teams.
  • Achieved President's Club for quality management systems.
  • Achieved 76% cost reduction.
  • Communicated with customers, management, and the sales team to better understand their needs and make recommendations.
  • Advised on post-market surveillance systems for adverse event reporting, achieving a 83% reduction in risk assessments' timeframes.
  • Achieved results in two years.
  • Advised pharmaceutical companies on regulatory submissions, reducing submission review times by 39%.
  • Implemented effective sales techniques and increased product sales to over $5 in 6 months.

Summaries

  • Costs were consistently reduced while profits were increased.
  • Accomplished market forecaster.
  • Professional with a passion for sales and customer service, as well as communication and negotiating skills.
  • Achieved 30% reductions in vendor contract terms.
  • Professional with workflow optimization and budget management expertise who is organized and resourceful.
  • Demonstrated success in converting prospects into customers, maintaining consistent sales levels, and servicing accounts.
  • Schedule flexibility and the ability to travel up to 7% of the time.
  • Customer service, research, and conflict resolution skills are all excellent.
  • Highly skilled and knowledgeable in the techniques used to close sales.
  • Exceptional at acquiring new customers and maintaining existing accounts to ensure consistent revenue growth.

Accomplishments

  • Led initiatives to address gaps in internal quality systems, resulting in sustained compliance during 9 consecutive regulatory inspections.
  • Created inspection readiness frameworks for sites and studies, leading to category during audits by metric.
  • Assisted a major pharmaceutical client in ensuring timely regulatory submissions, reducing review cycle times by 31%.
  • Led auditing preparation efforts for multi-country compliance inspections, ensuring 8% of all sites passed regulatory audits with no major findings.
  • Collaborated with research organizations to design and oversee clinical trials that met regulatory standards while under budget by 79%.
  • Documented and resolved standard which led to system.
  • Consulted on the resolution of compliance issues, preventing regulatory fines and operational delays valued at over $17.
  • Collaborated with team of 12 in the development of program.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Managed a Adobe Creative Suite platform transition that improved cross-departmental regulatory submission efficiency by 25%, reducing submission timelines by 18 months.

Affiliations

  • Participant, Clinical Data Interchange Standards Consortium (CDISC)
  • Certified Trainer, Pharmaceutical GMP Compliance in procedure
  • Fellow, Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Analyst Member, International Society of Pharmacoepidemiology (ISPE)
  • Member, International Society for Pharmaceutical Engineering (ISPE)
  • Alumni, Advanced Drug Development Program at initiative
  • American Marketing Association
  • Contributor, Advanced Clinical Trial Design and Management Conferences
  • Member, Academy of Managed Care Pharmacy (AMCP)
  • Contributing Member, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Certifications

  • CompTIA A+ Technician
  • Certified in Total Quality Management (TQM)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Toxicology Professional (CTP)
  • Certified Clinical Data Manager (CCDM)
  • IRB Compliance Certification
  • Good Manufacturing Practice (GMP) Certified Professional
  • Certified Quality Auditor (CQA)
  • Google Certified Professional Cloud Architect
  • Board Certified Pharmacotherapy Specialist (BCPS)

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