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QA Technical Writer

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -022020-26371 Region: Newark Metro Area

Job Description

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

Skills/Knowledge Required:

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.

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