Job Description


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Technical Writer

  • Ref: 291728
  • Type: Option-to-Hire
  • Location: Cranbury, NJ
  • Industry: Pharmaceuticals
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

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. 

Job Duties

  • 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.