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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Overview
Accomplished medical writer with broad expertise in preparing Phase I to III regulatory documents and in Pharmacovigilance.  Over 30 years of experience in the pharmaceutical industry. 
Education
Ferris State University Big Rapids, MI Expected in 1976 Pharmacy Degree : Pharmacy - GPA : Pharmacy
Albion College Albion, MI Expected in 1974 Bachelor's Degree : Chemistry - GPA : Chemistry
Professional Experience
Parexel - Senior Medical Writer
Two Buttes, CO, USA 04/2012 - 07/2016
  • Wrote clinical documents for submission to regulatory authorities including regulatory responses, clinical development plans, investigator brochures, clinical study reports, NDA documents (integrated summary of safety, clinical overview); IND applications, Risk Management profiles, DSURs, IMPD, Pre-IND Briefing documents, Phase I protocols, annual reports Acted as project manager / lead for edical writing projects by serving as primary client contact, negotiating deliverable timelines and solving project related issues.
  • Ensured document content and style adheres to FDA/EMA or other regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
  • Coordinated production and distribution of draft and final documents to project team and client.
  • Performed literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Ensured that Inventiv Health Clinical meets client expectations for medical writing projects.
Taylorville Memorial Hospital - Founder and Medical Writer Consultant
Springfield, IL, USA 04/2008 - 02/2012
  • Wrote clinical study reports (CSRs).
  • Oversaw the management of patient narratives for clients (assigned projects to other writers, proofread, routed to quality assurance, medical review, and provided feedback to writers).
  • Interacted with Medical, Clinical Research and Data Management for review of serious adverse events.
  • Reviewed CIOMS-I and MedWatch forms for serious adverse events.
  • Prepared reports for management on project status.
  • Assisted a client with migration from ArisG to Argus.
Perrigo Co - Senior Drug Safety Specialist
City, STATE, USA 11/2006 - 03/2008
  • Maintained proficiency in current knowledge of regulatory guidelines and regulations related to safety reporting.
  • Ensured that Perrigo was in compliance with safety reporting requirements worldwide.
  • Triaged and reported serious adverse events and product complaints for over-the-counter drug products and devices.
  • Entered adverse event data for prescription products and devices into a safety database.
  • Expertise in ArisG, Argus, Meds, Medics and other Drug Safety databases.
  • Prepared NDA Periodic reports and oversaw the outsourcing of PSURs (periodic safety update reports).
  • Reviewed CIOMS-I and MedWatch forms from market companies for serious adverse events.
  • Prepared reports for management on project status.
  • Prepared a systems requirement document for a safety database.
Walgreen's Pharmacy - Staff Pharmacist
City, STATE, USA 03/2006 - 11/2006
  • Filling prescriptions, counseling patients, routine pharmacist responsibilities.
  • Counseled patients on the use of pharmaceutical devices (e.g.
  • auto injection devices for migraine headaches; blood glucose monitoring, pregnancy tests).
Upjohn, Pharmacia And Upjohn, Pfizer - Medical Writer/Senior Drug Safety Specialist
City, STATE, USA 03/1985 - 03/2006
  • Provided regulatory consultation regarding safety reporting for investigational drugs Provided management oversight of the Global Safety and Pharmacovigilance group for a select group of products.
  • Prepared documents describing the process for monitoring and reporting serious adverse experiences (e.g.
  • SOPs) Acted as a project manager for stand-alone safety and pharmacovigilance projects.
  • Wrote clinical study reports in the therapeutic areas of CNS, Parkinson's disease, erectile dysfunction (injectable product), anxiety, anti-inflammatory, antibiotics, anti-HIV, etc.
  • Worked on the first injectable drug for erectile dysfunction and designed an instructional illustrated patient guide for the intracavernosal injection of the drug Wrote protocols, monitored clinical studies and reviewed case report forms.
  • Wrote the Integrated Summaries of Safety and Efficacy for the Mirapex NDA.
  • Wrote NDA periodic reports and periodic update safety reports.
Skills
I have maintained my pharmacy license and practiced retail pharmacy for over 20 years on a part-time basis. 
Additional Information
  • LICENSURE/CERTIFICATION
  •  Registered Pharmacist/Michigan 

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Resume Overview

School Attended

  • Ferris State University
  • Albion College

Job Titles Held:

  • Senior Medical Writer
  • Founder and Medical Writer Consultant
  • Senior Drug Safety Specialist
  • Staff Pharmacist
  • Medical Writer/Senior Drug Safety Specialist

Degrees

  • Pharmacy Degree
  • Bachelor's Degree

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