Regulatory Writer
- Looking for a writer with significant experience authoring Module 2 and Module 5 documents for NDAs and BLAs.
- Very straightforward regulatory submissions experience
- Required:Minimum of a BA/BS in Life Science; graduate degree preferred
- 4-7 years of pharmaceutical/biotechnology experience related to clinical research
- Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
- Ability to interpret and organize scientific and clinical data
- Medical writing experience in Pharma, Biotech and/or CRO; medical device experience preferred
- BA/BS + 7 years; MS/PhD + 4 years
- Experience with ICH and electronic submission guidelines for regulatory reports.
- Excellent written and verbal skills
- Good leadership, communication, and influencing skills
- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
- Ability to identify process improvements, manage change successfully, work with newer technologies, and foster an innovative atmosphere
- Applies good judgment and demonstrates initiative to resolve issues
- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred
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