Medical Writer resume example with 9+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
Summary
Medical Writer for pharmaceutical and medical device industry
Skilled in writing protocols clinical study reports, amendments, investigator brochures, clinical summary
Experiences, ISS & ISE, SOPs
Expertise in providing on time high quality report assignments
Detail-oriented, able to manage others and work independently
Co-authored several publications in The Journal of Clinical Microbiology
Medical laboratory professional skilled at precise documentation, isolating bacteria and processing and handling
clinical specimens.
Excellent diagnostic microscopy skills with gram-staining of cerebral spinal fluid, positive blood cultures, tissue,
and other biological specimens
Licenses
Medical Writing Certificate, trained in GCP, GLP, GDP, FDA & EMA regulations
Medical Laboratory Technologist trained and certified internally by
Brigham & Women's Hospital, Boston, MA (2004)
Skills
Bilingual fluent in Spanish Complex problem solver
Excellent Clinical Researcher via PubMed, On-time delivery of high quality project assignments
Cochran, FDA database Proficient in MS Word, MS Excel, MS PowerPoint
Excellent project management skills
Experience
Medical Writer, 09/2013 to 01/2014 Apex Systems – Mansfield, MA,
Provided quality project management with internal team members, CROs, and key decision makers in clinical
programs for oncology, systemic lupus erythematosus, and, osteoarthritis
Coordinated the preparation of investigator's brochures, protocols, clinical trial reports, International Medicinal
Product Development (IMPD) Common Technical Document Module 2.
INDs, briefing books, ISS, ISE, and, clinical summaries).
Medical Writer, 05/2008 to 08/2012 Apex Systems – Mechanicsville, VA,
Achieved on-time preparation of medical device project-driven documents that support the regulatory writing
needs of the BSC Preclinical Sciences department, Successfully completed synopses, protocols, preclinical
study reports, device analytical reports, departmental standard operating procedures (SOPs)
Successful development of QC, and, publication strategy of preclinical and clinical manuscripts
Worked successfully with members of preclinical, clinical, regulatory, R&D, and, project managers to develop and
manage timelines for timely and successful submission of regulatory documents to the FDA.
Successfully created documents for regulatory submissions in support of investigational device exemption-(IDEs)
for the common technical document (CTD).
Manager of Medical Writing, 11/2007 to 04/2008 Apex Systems – Medford, MA,
Management of writing projects in Regulatory Affairs & Quality
Worked on QA of data, appendices and references for all projects e.g.
clinical research reports, clinical study
reports (CSRs), investigator's brochures (IBs) and annual reports
Managed and ensured quality and consistency or multiple writing projects performed by external contractors and
clinical research organizations (CROs).
Therapeutic Areas: neurocognitive & oncology.
Medical Writer, 09/2007 to 11/2007 Agendia – Irvine, CA,
QA reviewed and edited of Velcade's promotional and manufacturer's package insert
Worked successfully with Millennium Managers to develop and manage timelines for timely and successful
submission of Velcade's package insert.
Therapeutic Area: oncology,.
Medical Writer, 04/2005 to 10/2007 Labcorp – American Fork, UT,
Wrote and prepared clinical protocols, clinical study reports (CSRs), brochures and common technical
documents (CTDs) write and revise internal standard operating procedures (SOPs) and pharmacovigilance
(PVG) safety protocols and write PVG safety narratives.
At the CEO's request, research and write high quality pre-clinical and clinical summary of safety (ISS) reports
for medical devices, pharmacological drugs, diverse therapeutic/disease indications and lumbar pain
measurement scales for submission to the Food and Drug Administration (FDA).
Microbiology Technologist, 06/2003 to 12/2004 Brigham & Women's Hospital – City, STATE,
Wrote and revised clinical microbiology media and test protocols, microbial identification via light microscopy
interpretation of Gram-stain, Giemsa and India Ink smears including regular and "stat" smears of cerebral spinal
fluid, blood and tissue, work-up of positive blood cultures and computer accession and labeling/planting of clinical
laboratory specimens.
Education and Training
J.D: Law Student, Expected in 2015 Massachusetts School of Law - Andover, MA GPA: Law Student
After much reflection having attended law school full-time during: , Expected in 2015 - , GPA: I discontinued law school to further pursue a career in medical writing.
Associate of Science: , Expected in 2001 Harvard Extension School - Cambridge, MA GPA: Post-Baccalaureate Pre-Medical Program
Bachelor of Arts: Sociology & Health Law, Expected in 1998 Brandeis University - Waltham, MA GPA: Sociology & Health Law
Interests
United States Army National Guard 2010-2012
Rank: Officer Cadet
Transferable Skills:
Leadership,
Teamwork,
Integrity,
Strong Work Ethic, and,
Loyalty
Status: Honorable Discharge
Activities and Honors
Skills
brochures, BSC, clinical research, clinical study, database, delivery, Ink, interpretation, law, MS Excel, MS PowerPoint, MS Word, Millennium, oncology, problem solver, Product Development, project management, protocols, publication, Quality, QA, Regulatory Affairs, regulatory documents, research, Researcher, safety, fluent in Spanish, strategy, strategic, annual reports
Additional Information
Community Service
United States Army National Guard 2010-2012
Rank: Officer Cadet
Transferable Skills:
Leadership,
Teamwork,
Integrity,
Strong Work Ethic, and,
Loyalty
Status: Honorable Discharge
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Resume Overview
School Attended
Massachusetts School of Law
Harvard Extension School
Brandeis University
Job Titles Held:
Medical Writer
Medical Writer
Manager of Medical Writing
Medical Writer
Medical Writer
Microbiology Technologist
Degrees
J.D
After much reflection having attended law school full-time during