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...