Technical Writer (Regulatory)

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

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

Qualifications

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