Job Description

Innova Solutions has a client that is immediately hiring for a Regulatory- Technical writer.


Position type: Full-time- Contract

Duration: 12 Months

Location: New Brunswick, NJ (50% onsite)



As a Regulatory- Technical writer you will:
  • Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses the health authority questions based on high quality technical reports.
  • Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
  • Manage the logistical process and detailed timeline for regulatory submissions.
  • Partner with SMEs across CTD to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
  • Provide input and sc...

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