QA Technical Writer
Newark Metro Area, NJ
Responsibilities will include, but are not limited to the following:
Document control & review process of all technical documents
Will work directly with Clients, and various departments to ensure documents are accurate
Organize and write supporting documents
Support Change Control activities
Support Periodic Review of Controlled Documents process
Document creation, modification, update to templates
Revise documents as new issues arise and maintain revision control
80% desk review/computer work
MUST HAVE Excellent technical writing and verbal communication skills (required).
If previously employed as a technical writer, have experience with Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD).
Work with cross functional teams to identify and close gaps, ensuring that the processes comply with Good Manufacturing Practices (GMP).
Proficiency in use of Microsoft Word, Excel, data graphics software, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process.
Knowledge of FDA and ICH guidelines.
Ability to work with multiple complex projects and within cross-functional teams.