Candidate Profile:
* Minimum 5 to 10 years of experience in working with or in pharmaceutical companies in Regulatory writing and Safety writing.
* Preferred area of TA expertise: Oncology
* Ability to synthesize data and present it in a written format.
* Understanding of document creation process and able to lead/own a study level document.
* Collective experience writing a range of safety documents for various therapy areas:
- Investigator’s Brochure
- Labeling Justification Documents
- Clinical Overviews and Clinical Summaries
- Safety Narratives
- Aggregate Reports
- Risk Minimization Plan and REMS
- ADR Frequency Assessment
* Strong written and verbal communication/presentation skills; with flair forwriting.
* Minimum 5 to 10 years of experience in working with or in pharmaceutical companies in Regulatory writing and Safety writing.
* Preferred area of TA expertise: Oncology
* Ability to synthesize data and present it in a written format.
* Understanding of document creation process and able to lead/own a study level document.
* Collective experience writing a range of safety documents for various therapy areas:
- Investigator’s Brochure
- Labeling Justification Documents
- Clinical Overviews and Clinical Summaries
- Safety Narratives
- Aggregate Reports
- Risk Minimization Plan and REMS
- ADR Frequency Assessment
* Strong written and verbal communication/presentation skills; with flair forwriting.
Additional Information:
Education: M.Phil, M.S./ M.D., M.Sc., MBBS, Ph.D, Pharm.D
Location: New Jersey
Experience: 5-10 years
Functional Area: Scientific Content
Last Date: 31th Dec, 2013
Education: M.Phil, M.S./ M.D., M.Sc., MBBS, Ph.D, Pharm.D
Location: New Jersey
Experience: 5-10 years
Functional Area: Scientific Content
Last Date: 31th Dec, 2013
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