- Job Level:
Technical Writer needed for a position in Cranbury, NJ. The Technical Writer is responsible for writing Standard Operating Procedures, Technical Transfer Documents, Pre-Development and Development reports. Manages documentation compliance and change control for R&D. Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs. Must perform all work independently with minimal supervision.
- Develops, writes and reviews/updates R&D SOPs.
- Writes Development and Pre-Development reports for R&D.
- Prepares documentation for submission of new ANDA filings.
- Assists in the response to FDA deficiency letters for ANDA filings for answering Pharmaceutics related findings.
- Prepares various summary forms for Pharmaceutics related projects as well as graphs, charts and statistical analysis for establishing product specifications.
- Designs, develops and implements databases to track key project deliverables and resource allocation within Pharmaceutics and updates on an on-going basis.
- Implements Document Management in R&D.
- Handles research and writing projects.
- Implements Change Control management in R&D.
- B.S/M.S/Ph.D. in Analytical Chemistry or related discipline with at least 7 years of general laboratory experience, including 3 years of technical writing experience in a pharmaceutical industry.
Experience & Skills Required
- Ability to meet attendance standards. All full-time employees are required to work a 40-hr week.
- At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
- Pharmaceutical principles, practices, and applications.
- cGMPs, Food and Drug Administration, and other regulatory compliance requirements.
- Documentation and technical writing principles and practices.
- English usage, spelling, grammar, and punctuation.
- Related business, scientific and personal computer hardware, and software applications.
- Communicating clearly and concisely, both orally and in writing.
- Strong organization skills, attention to detail, and the ability to work in a team environment.