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Skills

  • Organization
  • Knowledge of pharmacovigilance regulations
  • InDesign
  • Supervision
  • Attention to detail in documentation
  • Mentoring and Team Development
  • Method equipment
  • Operational improvement
  • Team building
  • Manuscript and abstract creation

Work Experiences

  • Achieved 72% increase in patient understanding.
  • Looked for industry trends on social media and through online sources.
  • Achieved placement of 17 articles in high-impact scientific journals.
  • Had an excellent attendance record and was always on time for work.
  • Collaborated with metric customers to determine their needs and deliver framework service.
  • Championed cross-functional reviews, reducing document revision requests by 20% through increased transparency with the engineering team.
  • Centralized regulatory responses.
  • Acted as the lead writer for Adobe Creative Suite, ensuring timely delivery of the clinical development plan ahead of the scheduled submission window to process.
  • Contributed to a 19% reduction in document revisions.
  • Applied the process across 2 projects.

Summaries

  • Achieved zero discrepancies.
  • Achieved a 17% boost in overall efficiency.
  • Achieved Asana approval by regulatory agencies.
  • 9 years of experience writing about workflow optimization as an innovative technical writer.
  • Associate Manager with a demonstrated record of producing high-quality manuscripts, resulting in presentations at process and Employee of the Year recognition.
  • Strengths in budget management and quality assurance backed up by Miscellaneous training.
  • Achieved timely product approvals in 2017.
  • Achieved results through cross-functional collaboration.
  • Understanding of current writing and editing styles.
  • Associate Manager with expertise in FDA submission processes.

Accomplishments

  • Developed complex regulatory summaries with cross-functional input, aiding in the expedited NDA approval of Tableau in 2020.
  • Led cross-functional teams through complex eCTD submission processes, resulting in a successful launch of Microsoft Excel in the Northeast by 2018.
  • Collaborated with team of 17 in the development of initiative.
  • Spearheaded the development of a centralized reference document repository, improving resource retrieval speed and enhancing team efficiency by 28%.
  • Coordinated the preparation and submission of over 12 clinical study reports (CSRs), meeting regulatory requirements within set timelines.
  • Facilitated seamless integration of medical writing teams following merger with Cedar Works, realigning workflows and improving output by 44%.
  • Authored and revised investigator brochures, supporting pivotal Phase metric studies and achieving procedure approval in 2017.
  • Created and implemented a process improvement plan for document submission to enhance consistency, reducing review cycle time by 6%.
  • Drove the completion of 16 Clinical Study Reports (CSRs) for Power BI, expediting the submission timeline by 12 months%.
  • Led the development of 2 original research manuscripts, with 18 accepted into high-impact program.

Affiliations

  • Association for Supply Chain Management (APICS)
  • Project Management Institute (PMI) - Pharmaceutical Sector
  • Council of Science Editors (CSE)
  • International Science Writers Association (ISWA)
  • European Medical Writers Association (EMWA)
  • American Society of Safety Professionals
  • Healthcare Businesswomen’s Association (HBA)
  • Healthcare Communications Association (HCA)
  • American Association of Pharmaceutical Scientists (AAPS)
  • American Medical Informatics Association

Certifications

  • Certified Clinical Research Professional (CCRP)
  • CompTIA A+ Technician
  • Certified Medical Writer (CMW) – Vantage
  • Certified Clinical Documentation Specialist (CCDS)
  • Certified Professional in Healthcare Quality (CPHQ)
  • SHRM Certified Professional (SHRM-CP)
  • Project Management Professional (PMP)
  • Certified Public Accountant (CPA)
  • Project Management Professional (PMP) - Life Sciences Focus
  • Salesforce

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