Technical Writer

DUTIES:

- 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
- Support and write documentation for approval of a drug
- Work with regulatory agencies, US. EU, Japan
- Biological licenses application

SKILLS:

QUALIFICATIONS:

- Scientific Background
- Analytical Chemistry; Biochemical
- Processes Regulatory background desirable
- Experience with Document 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) particularly the CMC section is required.
- Pharmaceutical
- Need to have experience writing a biological license application or supporting NDA - new drug application
- Experience supporting the CMC - control manufacture component
- Experience with analytical development, writing messages, specifications, batch analysis, stability tables
- Process development experience- understand how a drug is actually manufactured