LiveCareer-Resume

Medical Writer resume example with 9+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 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 SystemsMansfield, 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.
  • Successfully prepared strategic submission documents: (e.g.
  • INDs, briefing books, ISS, ISE, and, clinical summaries).
Medical Writer, 05/2008 to 08/2012
Apex SystemsMechanicsville, 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 SystemsMedford, 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
AgendiaIrvine, 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
LabcorpAmerican 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 HospitalCity, 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

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

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
  • Associate of Science
  • Bachelor of Arts

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: