Senior Medical Writer
Resume:
CURRICULUM VITAE
Melissa L. Earl, MPH
ADDRESS *** ****** **
Hemet, CA
*********@*****.***
EDUCATION
Graduate: Graduate School of Public Health
San Diego State University
Master of Public Health in Epidemiology
Undergraduate: California State Polytechnic University
Bachelor of Science in Veterinary Science
PROFESSIONAL EXPERIENCE
June 2019- Present Freelance Medical Writer
April 2000- Director of Medical Writing and
March 2019 Clinical Trials
Innovative Medical Data Solutions, Inc. (IMEDS)
Riverside, CA
July 1999- Clinical Research Manager/Medical Writer
April 2000 Hastings Healthcare
Laguna Beach, CA
April 1998- Project Manager/Medical Writer
July 1999 Department of Epidemiology
University of California, San Diego
San Diego, CA
QUALIFICATION SUMMARY
More than 25 years of experience in medical communications as an in-house and self-employed/freelance medical writer. Wide range of experience and expertise in medical and scientific writing, editing, project management, and KOL development for both devices and drugs. Substantial experience in the production of clinical protocols for Phase 1-4 studies, peer-reviewed clinical and scientific manuscripts, safety reports (including integrative summaries and narratives), review articles, CERs, clinical study reports, posters, slide presentations, letters to the editor, and journal supplements (including those based on symposia). Experience includes development of regulatory materials for all phases of product development. Have also developed product monographs, meeting highlight reports, textbook chapters, managed care materials, white papers, and marketing materials.
Extensive experience in designing and managing clinical trials for both industry-funded and physician-sponsored clinical trials in the United States and the European Union. Responsible for site recruiting, developing and managing project budgets. designing data collection forms, writing and developing protocols, determining statistical plans, preparing and submitting reviews for regulatory authorities and institutional review boards, trial management, overseeing data collection and processing, performing statistical analyses, preparing data summary reports, and final clinical trial reports.
Regulatory experience (comprising early development to post-marketing) includes preparation and submission of NDAs, INDs (both industry- and physician-sponsored), PMAs and 510ks. Extensive experience in development of safety narratives and reports, CERs, as well as development of safety labels.
Experience in a wide range of medical specialties including ophthalmology, oncology, dermatology, neurology, infectious disease, allergy and anaphylaxis, urology, bariatrics, diabetes, interventional radiation, rheumatology, pharmacoeconomics, psychology, plastic surgery, hospital epidemiology and nosocomial infection.
FREELANCE MEDICAL WRITING
2019- Present
Authored and edited numerous documents on an ad-hoc basis for both drugs and devices. Projects included writing and reviewing protocols, manuscripts, abstracts, CRFs, and regulatory submissions for the FDA and EU regulatory authorities. Responsible for quality control for same.
Developed and reviewed various databases and statistical analyses for several large projects.
Volunteer for Riverside County Health Department during CoVid-19 pandemic.
oAdvocated for distribution and administration of CoVid-19 vaccine.
Applied epidemiological expertise to the collection and quality control of incidence and prevalence data throughout the county.
oAuthored and ensured accuracy of content for patient and physician-oriented materials (websites, brochures, Q&A pamphlets, etc.)
DIRECTOR OF MEDICAL WRITING
Innovative Medical Data Solutions, Inc
Riverside, CA
2000-2019
Regulatory Writing (Drugs and Devices):
Responsible for the development and writing of Clinical Protocols (Phase I-IV), ICFs, Investigator Brochures, CSRs, study updates and summaries.
Preparation and submission of NDAs, INDs (both industry- and physician-sponsored), PMAs and 510ks.
Extensive experience writing and managing CERs and other documents for EU Regulatory Authorities under MEDDEV 2.7.1 rev 4 and MDR.
Extensive experience in development of safety narratives and reports, CSRs and CERs, as well as development of safety labels.
Responsible for development of Post-Marketing programs and documents including Phase IV Programs, Patient Registries, PMSs, and PMCFs.
Publication Writing (Drugs and Devices):
Authored abstracts, manuscripts, posters, podium presentations, editorials, reviews, and textbook chapters.
Developed written content for Advisory Board meetings and symposia.
Prepared CME material for physician and healthcare-provider audiences.
Developed website content for patient registries.
Partial Client Listing
LensAR, Inc
Orlando, FL
2015-2019
Medical Writer. Prepared posters, abstracts, and podium presentations for this medical device company.
Allergan, Inc
Irvine, CA
1999-
Medical Writer /Clinical Trial Manager. Prepared numerous peer-reviewed manuscripts, posters, abstracts, and podium presentations. Worked with physicians to develop and implement clinical trials. Responsible for protocol design and development for both drug and device studies. Prepared CERs. Designed and distributed data collection forms, prepared ICFs, developed databases, oversaw data collection and recording processes and quality control. Recruited physicians for multi-site studies, analyzed data and prepared clinical study reports for sponsors. Developed and implemented national and international surveillance studies. Experience ranged across this company’s entire drug and device portfolio (glaucoma, anti-infectives, neurology, gastric banding, aesthetics, over-active bladder, etc.).
Abbott Medical Optics, Inc
Santa Ana, CA
2006-
Medical Writer/Clinical Trial Manager/Biostatistician. Prepared scientific articles, posters, white papers, and abstracts for this client. Responsible for protocol design, development, and implementation of clinical trials for a wide range of client’s device portfolio (laser platforms, intraocular lenses, etc.). Designed and distributed data collection forms, prepared CERs, ICFs, developed databases, oversaw data collection and recording processes, recruited physicians for multi-site studies, analyzed data and prepared clinical study reports for sponsors. Responsible for quality control for all projects.
Pacific Communications,
Costa Mesa, CA
1999-2012
Medical Writer. Developed manuscripts, podium presentations, abstracts, posters, white papers, promotional materials, and textbook chapters for clients in the pharmaceutical industry and for physicians. Assisted in the development of publication plans. Worked with accredited providers to develop CME program materials. Attended scientific meetings and prepared reports for clients from same. Functioned as a liaison between physician VIPs and industry clients. Worked to increase staff understanding of statistical reports and clinical summaries. Developed managed care reports and materials.
Glaukos Corporation
Mission Viejo, CA
2005-2012
Medical Writer/KOL Development/Clinical Trial Consultant. Developed clinical protocols, prepared ICFs, CERs, investigator brochures, and clinical study reports for this client’s device trials. Periodically prepared clinical study reports, scientific articles, white papers, posters, educational programs, and abstracts for this client. Used extensive physician contacts to recruit clinical trial investigators and developed relationships between key opinion leaders and this client.
Ista Pharmaceuticals
Irvine, CA
2007-2012
Medical Writer/Clinical Study Manager/Biostatistician. Responsible for developing/writing clinical protocols for Phase 2 to Phase 4 clinical trials. Designed and distributed data collection forms, prepared ICFs, recruited physicians for multi-site studies, developed databases, oversaw data collection and recording processes, analyzed data and prepared clinical study reports and CERs. Prepared numerous investigator brochures and peer-reviewed manuscripts, posters, abstracts, and podium presentations.
Pascale Communications
Pittsburgh, PA
2005-2014
Medical Writer/Biostatistician. Periodically prepared clinical study reports, scientific articles and abstracts for this client in the areas of optometry, ophthalmology, cardiology, and oncology. Analyzed clinical trial data for presentations at major conventions and for publication.
Access Communications
La Jolla, CA
2003-2006
Medical Writer. Periodically prepared manuscripts, podium presentations, posters, abstracts, white papers, and CME programs for this client. Primary focus was in the field of aesthetic dermatology.
Valeant Pharmaceuticals, Inc.
Costa Mesa, CA
2005-2010
Medical Writer/Speaker. Prepared protocols, prepared ICFs, clinical study reports, investigator brochures, scientific articles, posters, white papers, and abstracts for all phases of development. Developed and presented posters and podium presentations at major international meetings.
Allergan, LLC
Sydney, Australia
2001-2002
Biostatistician/Medical Writer. Collected retrospective patient data for clinical research, performed biostatistical analysis of data and presented it to physicians. Developed manuscript from same.
MediMedia, Inc
Yardley, PA
2006- 2008
Medical Writer. Periodically prepared slide sets, sales aids, and presentations for this agency client.
Slack, Inc
Thoroughfare, NJ
2001-2004
Medical Writer. Periodically developed CME program materials for national programs. Developed promotional materials for industry and physicians.
RLM Public Relations
Los Angeles, CA
2003-2005
Freelance Medical Writer. Periodically worked with in house staff to develop promotional materials and press releases.
Forte, Inc
Tokyo, Japan
2001- 2002
Freelance Editor/Medical Writer. Provided editing and writing assistance on manuscripts and review papers developed by authors who did not speak English as a first language.
Hastings Healthcare
Laguna Beach, CA
1999-2000
Clinical Research Manager/Medical Writer. Developed manuscripts, podium presentations, abstracts, posters, white papers, promotional materials, and textbook chapters for pharmaceutical clients and physicians. Functioned as a liaison between physician VIPs and industry clients.
University of San Diego Medical Center, Hillcrest
Department of Epidemiology
San Diego, CA
1998-1999
Project Manager/Medical Writer. Developed and implemented the first proof-of- concept clinical trial for alcohol-based hand sanitizing gel in a hospital setting. Hired, trained, and supervised study staff. Responsible for protocol development, data analysis, presentation, and peer-reviewed manuscript. This project was the basis of my MPH thesis and funded by the Kimberly-Clark Corporation.
PROFESSIONAL MEMBERSHIPS
American Medical Writers Association
Association for Research and Vision in Ophthalmology
American Public Health Association
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