Technical Writer (Regulatory)
Artech Information System LLC
Apply to this jobArtech 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.
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
Summary
Write scientific and regulatory documents, verify data, prepare templates, support BLA submissions.
Job title
Technical Writer (Regulatory)
Experience level
3-4 years
Industry
software
Location requirements
Chesterfield, MO, US; remote not specified
Salary
Not specified
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Chesterfield, MO, USA