Technical Writer (Regulatory)

Technical writing of scientific documents in support of regulatory filings. Preparation of analytical documents and data summaries using standard electronic publishing tools.Create and maintain templates for both non-GMP and GMP documents.Draft documents from raw data. Verify the data that is contained within regulatory documentation" "Scientific Background; Analytical Chemistry; Biochemical Processes Regulatory background desirable Experience with Documentum Proficiency in Microsoft Office Products (excellent computer skills) Excellent oral and written communication skills Effective interactive skills Detail oriented Degree in Molecular Biology or Analytical Chemistry is preferred. 3-4 years previous experience with submissions or BLA'S (Biologic License Applications) particulary the CMC section is required

Scientific Background; Analytical Chemistry; Biochemical Processes Regulatory background desirable Experience with Documentum Proficiency in Microsoft Office Products (excellent computer skills) Excellent oral and written communication skills Effective interactive skills Detail oriented Degree in Molecular Biology or Analytical Chemistry is preferred. 3-4 years previous experience with submissions or BLA'S (Biologic License Applications) particulary the CMC section is required