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Click here or scroll down to respond to this candidateCandidate's Name
Street Address W. Acoma #53Glendale, AZ Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEPROFESSIONAL EXPERIENCEGossamer Bio10/2018-PresentSenior Manager, Medical Writing Wrote protocols, CSRs, IBs and Module 2 documents for hypertension, colitis, and oncology products Wrote and managed clinical and non-clinical IND submissions (10 total) Managed medical writing team Project-managed all medical writing projects Hired and trained junior medical writers Developed and refined internal medical writing processes Provided medical writing management for successful INDs Wrote briefing documents, PIPs, and regulatory responsesNew Link Genetics06/2017-09/2018Senior Medical Writer/Medical Writing Manager Wrote protocols, CSRs and IBs for oncology products Worked on indoximod-based therapy for melanoma, pancreatic, breast, and brain neoplasms Lead writer on IND and NDA for indoximod HCl product Managed medical writing groupMRS, Inc.08/2014-06/2017Senior Medical/Technical Writer Wrote 510k documents for FDA submission Wrote CERs for European submission Wrote documentation for mechanical ventilator products Managed medical and technical writing teamSanten Pharmaceuticals/Talent Mine02/2014-08/2014Senior Regulatory Medical Writer Writer and editor of regulatory documents for ophthalmology products Worked primarily on therapy for posterior uveitis Wrote and edited protocols and CSRs for US, Japanese and European submissions Wrote and edited IBs, ISS/ISEs, Modules 2.7.3, 2.7.4, and 2.5 documents for sirolimus product Reviewed and updated SOPs and internal writing style guides Wrote and edited patient narratives Worked in SAS, Microsoft Office, Documentum and EndNote Project manager for sirolimus program Managed medical writing teamMallinckrodt Pharmaceuticals/Kelly Services10/13-04/14Regulatory Medical Writer Wrote NDAs, protocols, CSRs and IBs for Mallinckrodt pain products (lead writer on one NDA) Reviewed and updated SOPs and internal writing style guides Wrote and edited patient narratives Worked in SAS, Microsoft Office, Documentum and EndNote Managed medical writing team Managed medical writing timelines Led kickoff meetingsCygnus Corporation01/2002-10/2013Regulatory Medical Writer Clinical writer of regulatory documents for pain and oncology products Worked on Phases I-III on multiple products Wrote NDAs, INDs, protocols, CSRs, IBs, Appendices, individual case report forms, and ISS/ISEs for pain and oncology products (Lead writer on eight NDAs and nine INDs) Reviewed and updated SOPs and internal writing style guides Wrote and edited CSRs, IBs, ISS/ISEs, manuscripts, posters, and abstracts Wrote and edited patient narrativesReliance Medical Information06/1991-01/2002
Medical Writer/Editor Wrote manuscripts, abstracts, and posters for a variety of sponsors in wide range of therapeutic indications Wrote summaries of biomedical research published in journals for physician audience Wrote review articles and meta-analyses on a variety of diseases and therapiesEDUCATION2013 Master of Business Administration, Florida Institute of Technology2012 Master of Science in Clinical Research Administration, Walden University2006 Master of Science in Pharmacy, University of FloridaB.S, Biochemistry, University of New Mexico |
