Job Description

Apply

Submit Email

If you've inquired to HumanEdge in the past, please use the same email to help shorten the inquiry process. If you've never inquired or don't remember, you may use any valid email address.

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.

Education

  • 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.