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Medical Writer/CRF Designer with 22 months experience

Bloemfontein, Other - Outside US/Canada

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  • Job Target: CRF Designer
  • Employment Status: Unspecified
  • Experience Level: Not Specified
  • Seeking: Full-Time
  • Industry: Pharmaceutical Resumes
  • Salary: Difficult to say. Think thi...
  • Degree: Not Specified
  • Security Clearance: None
  • Travel: Not Specified
  • Relocate:: No

Objective

I am seeking a full time position as CRF designer with a CRO or CRF design or pharmaceutical company.

Job Target

CRF Designer

Professional Experience

2004 – present Quintiles South Africa
Medical Writer II

Until very recently, my main function as Medical Writer II was to design paper CRFs for Phase I, II and III clinical studies using MS Word and Bookmaker Font. My responsibilities also included, and in my current position will in future mainly consist of writing Clinical Research Reports for Phase I studies. In the production of CRRs, it is my responsibility to pay close attention to the quality, completeness, consistency, wording, table design, appendices, structure, layout, version control and compliance with international medical writing guidelines.

I work closely with a statistician on each project to appropriately address the statistical aspects of each CRF/report. I directly liaise with representatives of pharmaceutical companies globally to ascertain their needs and obtain the information required for producing medical writing deliverables.

My other main responsibility is the review of medical writing deliverables (Clinical Research Reports, Protocols and CRFs) produced by other medical writers in our Biostatistics group.

2003 – 2003 University of the Freestate
Lab Demonstrator

In this position I was responsible for assisting 3rd year Biochemistry students with their practical sessions, i.e. education on lab practice and techniques and to help with calculations and report writing. My responsibilities also included the preparation of stock chemicals and the setting up of glassware for practical sessions. This was a student position.

Education

2005 Quintiles South Africa
– Doctorate (PhD/MD/JD)

In 2005, at Quintiles, my professional education included: education on/in/a: Project Management Workshop, Dimensions of Professional Selling, Design and Analysis of Bioequivalence Studies and Procedures for Hosting FDA Inspections,as well as a Malaria Information Session

2004 Quintiles South Africa
– Doctorate (PhD/MD/JD)

In 2004, at Quintiles,my professional education included: education on/in: ICH/Good Clinical Practice, Global Customer Focus, and an Overview of Drug Development and Clinical Trials

2003 University of the Freestate
– Bachelor's Degree (BA/BS)

In 2003, I received my BSc Biochemistry Hons. degree, with distinction, from the University of the Freestate

2002 University of the Freestate
– Bachelor's Degree (BA/BS)

In 2002, I received my Bachelors degree in Biochemistry (BSc Biochemistry) with distinction from the University of the Freestate, Bloemfontein, South Africa

1999 President Steyn Secondary School
– High School (Diploma/GED)

I graduated from high school with the following subjects: Afrikaans Language, English Language, Mathematics, Accounting, Biology, Science and Geography

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Last updated on: 2006-01-15.