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 Apply Job! Apply to this Job