For high-quality scientific documents that comply with applicable guidelines.
EDUCATION, TRAINING, & CERTIFICATIONS
Essential Skills Certificate
from the American Medical Writers Association (AMWA),
earned in 2011.Editor in the Life Sciences Certificate
from the Board of Editors in the Life Sciences (BELS),
earned in 2006.Postdoctoral Research
in pharmacology and toxicology with a neuroscience focus at the University of Arizona,
conducted 2005 to 2007.Doctor of Philosophy (PhD)
in analytical chemistry with a neuroscience focus from the University of Texas at Austin,
grade point average = 4.0 of 4.0,
earned in 2005.Bachelor of Science (BS) with honors
in chemistry from the University of Toledo in Ohio,
grade point average = 3.9 of 4.0,
earned in 2000.
MEDICAL WRITING EXPERIENCE: Industry
Johnson & Johnson Innovative Medicine (previously Janssen Research & Development)
Half-time Principal Medical Writing Scientist, 2019 to present.
Principal Medical Writing Scientist, 2016 to 2019.
Senior Medical Writing Scientist, 2012 to 2016.
Deliverables for which I provided writing (or oversight of outsourced writers) included the following:
Study-related documents,
such as protocols and amendments,
investigator's brochures (IBs),
clinical study reports (CSRs), and
participant narratives.Clinical overviews to support changes to labeling,
including Company Core Data Sheets (CCDSs),
United States Prescribing Information (USPIs),
and European Union Product Information (EUPIs).Safety documents,
such as Development Safety Update Reports (DSURs)
and European Union Risk Management Plans (EU-RMPs).Requests to health authorities,
including a successful Breakthrough Designation request,
Pediatric Study Plan (PSP) waiver requests,
and briefing documents.Responses to health authorities,
regarding assessments of protocols, labeling changes,
or safety documents (EU-RMPs,
periodic safety update reports [PSURs], and
periodic benefit-risk evaluation reports [PBRERs]).Electronic common technical document (eCTD) components,
for 2 successful supplemental New Drug Applications (sNDAs)
and 1 successful initial NDA. These components were:
- 1 integrated summary of safety (ISS) and
- 2 summaries of clinical efficacy (SCEs).Literature reviews and position papers,
to compare the company's data against external/published data.
Therapeutic areas included schizophrenia, depression, migraine, dementia, autism, multiple sclerosis, and others.
Products included prescription medications, drug-device combinations, and diagnostic companions.
Departmental support included participation in process improvement initiatives for quality control (QC) of documents, for controlled software to collaboratively author and review documents, and for CSR best practices.
Writing standards conformed to:
Internal:
content review by nonclinical, clinical, safety, biostatistics, and regulatory departments as applicable;
rigorous matching to Standard Operating Procedures;
plus technical and content QC standards.External:
the American Medical Association (AMA) Manual of Style for format,
and guidances from the relevant Health Authorities for content.
Supplemental experience/training included a job shadowing rotation through the Pharmacovigilance Evaluation and Reporting department in 2017.
Alcon Laboratories
Senior Medical Writer II, 2011 to 2012.
Senior Medical Writer, 2008 to 2011.
Deliverables included abstracts, posters, presentations, peer-reviewed manuscripts, and CSRs.
Therapeutic areas included ophthalmologic devices (surgical tools, intraocular lenses, contact lenses); prescription medications (glaucoma, anti-inflammatory, antibiotic, allergy); and consumer products (dry eye drops, lens solutions).
Writing standards conformed to:
Internal:
review by regulatory, legal, trademarks, marketing, engineering, and medical affairs colleagues.External:
principles established by the International Committee of Medical Journal Editors (ICMJE),
the Consolidated Standards of Reporting Trials (CONSORT),
and the AMA Manual of Style.
Departmental support included serving as database administrator for planning, tracking, and reporting the quantity and characteristics of hundreds of publications and presentations every month, quarter, and year.
MEDICAL WRITING & EDITING EXPERIENCE: Agency
Arbor Scientia (a medical education agency)
Senior Medical Writer, 2008.
Medical Writer, 2007.
Deliverables included slide kits, monographs, training materials, and storyboards.
Therapeutic areas included psychiatry, neurology, and women’s health.
Clients included Wyeth, Pfizer, Novartis, GlaxoSmithKline, and others.
Occasional Freelance Work (nights & weekends):
Content development for Arbor Scientia, 2009 to 2010.
Copyediting for MedCom Asia Inc, 2006 to 2008.
HONORS & AWARDS
Janssen / Johnson & Johnson Family of Companies:
Inspire Awards:
In 2024 once (for a penpal program connecting medical writers in Asia to medical writers in the US and EU).
In 2023 three times (1 for providing QC orientation, 1 for drafting a mental health best practices document, and 1 for participating in the rollout of a new departmental resourcing tool).
In 2022 once (for 10 years of service).
In 2021 twice (1 for advocacy of a document review system, 1 for a paper about gastric safety of aticaprant).
In 2020 three times (1 for participation with a new document review system, 1 for contribution to a ponesimod CSR, and 1 for contribution to paliperidone submissions).
Encore or Leadership Awards:
In 2019 once (for an esketamine SCE).
In 2018 once (for an esketamine SCE).
In 2016 three times (1 for large-scale QC comparisons, 1 for "lean writing” analysis of CSRs, and 1 for a paliperidone EU‑RMP).
In 2015 once (for small-scale QC comparisons).
In 2014 three times (1 for "lean writing” analysis of IBs, 1 for a risperidone response document, and 1 for a topiramate ISS).
In 2013 once (for the esketamine breakthrough designation document).
Society for Neuroscience:
In 2006, a travel award to present a poster at their national meeting.
University of Texas:
In 2005, Outstanding Graduate Student in Chemistry Employee Nominee.
National Science Foundation:
In 2001, Graduate Research Fellowship Honorable Mention.
University of Toledo:
In 2000, Outstanding Senior in Chemistry Award.
In 1999, Analytical Chemistry Award (first in class).
In 1999, Biochemistry Award (first in class).
RELEVANT SOFTWARE PROFICIENCIES
I have experience with databases (Microsoft Access, Reference Manager, EndNote); document review systems (ERIS, PleaseReview, RIMdocs); spreadsheets (Microsoft Excel, Google Sheets); word processors (Microsoft Word, Google Docs); presentations (Microsoft PowerPoint); etc.
