Description
A global leader in Pharmaceuticals, located in Illinois, is in need of a Medical Writer. The company is the 12th largest pharmaceutical company in the world with marketed drugs in over 80 countries.The Medical Writer will have the following responsibilities:
- Compile and analyze data
- Prepare international and domestic documents
- Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs, PADERs and associated documents
- Participate in strategy meetings to review project time lines and data
- Ensure data issues are resolved prior to document sign off
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Work closely with global safety lead
- Generate a risk management plan
The Medical Writer must meet the following requirements:
- B.S.
- 5 years experience in pharmaceutical environment (pharmacovigilance preferred)
- Excellent writing skills
- Familiarity with DSURS and PSURS
- Excellent understanding of Pharmacovigilance regulation requirements for aggregate safety report preparation and drug approval processes
- Familiarity with medical terminology and technical writing
- Strong understanding of EU and FDA regulations
- Proficiency working with Microsoft Office applications
- Proven communication and interpersonal skills
- Team oriented
This is a 6 month contract position, $30-$35/hour (negotiable). If you are interested please apply now!
To find out more about Real please visit www.realstaffing.com