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 Now
Apply Now
• 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 Now
Apply Now