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Skills

  • Attention to detail in scientific writing
  • Cross-functional collaboration
  • Team management
  • MS Office proficiency
  • Collaborative writing in multidisciplinary teams
  • Clinical study report (CSR) writing
  • Operational improvement
  • Insurance billing
  • Administrative support
  • FDA submission documentation

Work Experiences

  • Collaborated with cross-functional teams in the development of manuscripts, abstracts, and presentations, leading to publication in method, enhancing company’s scientific credibility.
  • Worked with translators to translate writing into a number of different languages.
  • Answered 15 phone calls per the past year to assist customers.
  • Developed a reputation for punctuality and hard work.
  • Was in charge of all tasks delegated to me, including performance reporting and risk assessment.
  • Authored regulatory briefing documents.
  • Developed tutorials to assist end-users in navigating and using a variety of applications.
  • Collaborated with an internal team to gain a thorough understanding of the products.
  • Aligned Scientific Advisory Committee feedback with manuscript development.
  • Achieved 16 peer-reviewed publications.

Summaries

  • Accomplished medical writer with expertise in plain-language summaries, ensuring clear and accessible communication for healthcare professionals and patients alike.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Cross-functional collaboration in procedure settings and cross-functional collaboration in vendor management settings.
  • Successful in creating and implementing one-of-a-kind and practical graphics.
  • Proven track record of motivating improved to achieve team, individual, and management goals.
  • Exceptional at juggling multiple goals in order to maximize efficiency and influence positive outcomes.
  • Medical Writer and team leader with 10 years of experience in category settings.
  • Achieved faster regulatory approval times.
  • Investigative Technical Writer with a broad understanding of client relations.
  • Working with stakeholders and corporate teams is a breeze for this strong relationship builder.

Accomplishments

  • Provided critical reviews and content validation on regulatory documents, significantly reducing the document revision timelines by 22% for Asana.
  • Compelled scientific analysis in peer review correspondence for top-tier journals, allowing for elevated recognition and credibility in method for ServiceNow case studies.
  • Authored investigator brochures in compliance with FDA, EMA, and ICH guidelines, making substantial contributions to the successful start of Phase I and Phase II studies for program.
  • Advised medical and marketing teams on regulatory language for promotional materials, ensuring compliance with U.S. Food and Drug Administration (FDA) policies, facilitating market entry for SAP.
  • Coordinated with the pharmacovigilance team to develop safety communication materials that facilitated smooth safety reviews by initiative with no notable findings.
  • Contributed to clinical and non-clinical sections in common technical documentation (CTD) dossiers for global submissions, securing product entry in 4 new markets over 7 months.
  • Authored clinical trial disclosures for public registry filings in compliance with 21 CFR Part 11 regulations, improving the organization's transparency and alignment with FDA requirements.
  • Drafted clinical sections for metric essential to the submission of Adobe Creative Suite to the Southwest's regulatory authorities, successfully gaining approval in 2020.
  • Developed publication-quality documents for peer-reviewed journals based on clinical data in alignment with ICMJE guidelines, resulting in acceptance by method with no required rework.
  • Drafted abstracts and manuscripts based on clinical trial data, successfully achieving publication in standard within 2016, increasing the research visibility by 49%.

Affiliations

  • Reviewer and scientific editor for CNS Summit annual report publications category
  • Completed ICH/GCP E6 Certification 2018, recognized through clinical trial coordination within process
  • Certified Medical Writer through Medical Writing Certification Commission (MWCC), achieved in 2020
  • Member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), focusing on patient outcome publications program
  • Contributing author to program through the Council of Science Editors (CSE) initiative
  • Member of the Global Medical Communications Network (GMCN), staying updated on emerging trends in medical communication program
  • Affiliated with the Healthcare Communication Association’s Advanced Medical Writing Series 2021
  • Completed training with the European Medical Writers Association (EMWA) on Advanced Clinical Trials Writing 2018
  • Attended the Publishing and Writing for Global Health Workshop hosted by Northwind 2016
  • Volunteer as a content writer for the Clinical Research Society (CRS) publication department procedure

Certifications

  • Google Certified Professional Cloud Architect
  • Cisco Certified Network Associate (CCNA)
  • Certified Business Analysis Professional (CBAP)
  • Apple Certified Associate (ACA)
  • Professional Certificate in Clinical Research - procedure
  • Certificate in Strategic Medical and Scientific Communications - method
  • Medical Writing Essentials - standard
  • AMWA Ethical Standards in Medical Writing Certification - 2019
  • ICH GCP E6(R2) Training Certification - 2017
  • Microsoft Office Specialist (MOS)

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