Resume
Resume
Work Experience
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Technical Writing Consultant — Sep 2023 to Present
● Supported the writing, editing, and transfer of SOPs from Antares Pharma to Halozyme.
● Managed reviews and approvals in MasterControl and Veeva software per QSR (21 CFR 820) and ISO 13485.
Senior Technical Writer — Mar 2022 to Dec 2022
- Served as technical writing consultant on the Technical Transfer team to support new IVD products.
- Provided document control support to submit 2 SARS-CoV-2 assay kits for CE IVDD certification in 3 months.
- Started, managed, and completed 50+ change orders in Grand Avenue Software to meet the deadline for IVDD submissions.
- Drafted and reviewed technical documentation (SOPs, WIs, V&V reports, IFUs, SDSs, others) for transfer from R&D to Manufacturing and Regulatory Affairs. Maintained templates for SOPs and WIs.
Senior Technical Writer — May 2019 to Mar 2022
- Edited regulated labeling (package inserts and IFUs) for Procleix blood assays and instrument user manuals for Procleix Panther System (hardware and software).
- Initiated and managed document/engineering change orders through Documentum system per QSR/ISO 13485.
- Collaborated with other SMEs to create/update technical documentation. Created redlines for document reviews. Drove review cycles tactfully to meet deadlines.
- Managed translation workflows with an external vendor.
- Proactively managed multiple projects to meet shifting priorities.
- Managed document transfers and coordinated reviews between Grifols and business partners.
- Supported internal audits and CAPAs as needed.
- Supported efforts to consolidate and streamline SOPs for the joint Hologic/Grifols writing team. Trained new writers.
Technical Writer (FTE) — Jan 2017 to Mar 2019
Technical Writer (Contractor) — May 2016 to Jan 2017
- Updated package inserts and IFUs for cardiac rhythm management devices and pacing leads.
- Conducted in-person and online review meetings with SMEs. Proactively managed multiple projects to meet shifting priorities.
- Coordinated tightly with Regulatory Affairs to manage schedules in order to resolve clashing regulatory strategies.
- Initiated and tracked document/engineering change orders through TeamCenter Enterprise system per QSR/ISO 13485.
- Managed user manuals and technical literature in XML-based content management system (Author-It).
- Managed translation workflows with internal translation team.
- Trained new writers.
Technical Writer II — Jul 2013 to May 2016
- Updated regulated labeling (IFUs) and patient-facing user manuals for insulin pumps, continuous glucose monitoring systems, and consumable products.
- Represented technical communications group on project core teams. Collaborate cross-functionally with other teams (Regulatory Affairs, Quality, Systems Engineering, Clinical Affairs, etc). Participated in phase reviews with core teams.
- Tactfully led technical reviews in-person and via teleconference with shareholders.
- Initiated and tracked document/engineering change orders through enterprise software (SAP) per QSR/ISO 13485.
- Managed user manuals in XML-based content management system (Vasont).
- Managed translation workflows with Medtronic's translation team.
- Supported Systems Engineering to create claims traces and gap assessments.
- Maintained department style guide in coordination with Medtronic's international style guide team.
- Trained new writers in department procedures and content management system.
- Performed peer reviews to achieve technical standards and regulatory requirements.
- Trained in GDP, GMP, HIPAA/data privacy, ISO 13485, 21 CFR 820, and labeling requirements.
Bachem — Technical Marketing Writer
May 2011 to Jun 2013
As sole writer on marketing team, produced a monthly email newsletter distributed to 20000+ customers. Performed literature searches. Wrote feature articles on academic and industry peptide research. Compiled news items on peptide technology. Wrote articles on Bachem peptide products and custom peptide services. Also, performed search engine optimization (SEO) of the website. Developed microsite and search engine marketing (SEM) campaign for Melusine venom library. Increased web traffic by 200%.
Life Technologies — Web Content Specialist
Apr 2010 to Apr 2011
Developed a style guide to improve product descriptions in Life Technologies online catalog. Trained 100+ product managers in writing customer- and SEO-friendly product descriptions. Led project to revamp 500+ online catalog entries to improve click-through and increase sales.
City of Hope National Medical Center — Medical Writer
Sep 2006 to Mar 2008
Provided scientific, data analysis, and writing support to clinicians. Prepared 5+ manuscripts and 20+ poster abstracts. Prepared 15+ slide decks for continuing medical education lectures, scientific meetings, and patient groups in topics of diabetes and endocrinology. Performed scientific literature searches. Interpreted data. Copy edited 2 medical textbooks per AMA and publisher's style guide. Coordinated with 20+ authors on 60+ chapters. Wrote an introductory chapter.
Educational Experience
Keck Graduate Institute, Claremont, California
- Cell and molecular biology of metabolic gene regulation in the industrial yeast Pichia pastoris in response to carbon source.
- Provided biological support to bioinformatics groups, including sequencing and annotation of the Pichia genome.
- Copy edited Pichia Protocols, 2nd Edition.
University of California — San Diego, California
- Studied the intersection of metabolism, post-transcriptional gene regulation, and RNA stability in the yeast Saccharomyces cerevisiae.
- Dissertation, "Selective translation and regulated decay of yeast mRNAs in response to carbon source: cis elements and trans factors." [Abstract and Introduction].
University of California — Santa Cruz, California
- Honors Thesis, "A Molecular Phylogeny of Neurospora crassa, Saccharomyces cerevisiae, and Schizosaccharomyces pombe based on the F-type and V-type ATPases."
- Self-taught PHYLIP and Intelligenetics/GCG software packages on SUN workstations.
- Miscellaneous filamentous fungus (Neurospora crassa) techniques.