Technical writer

Innova Solutions•New Brunswick, NJ

9d•Hybrid

About The Position

Innova Solutions has a client that is immediately hiring for a Regulatory- Technical writer. This is a full-time, contract position with a duration of 12 months. The role is hybrid, requiring 50% onsite work in New Brunswick, NJ. As a Regulatory- Technical writer, you will be responsible for co-authoring/authoring scientific content for CTD Quality sections, aligning with regulatory strategy for clinical and life-cycle CMC regulatory submissions. This includes responding to health authority questions based on high-quality technical reports. You will plan and facilitate submission kick-offs for clinical regulatory submissions across CTD pipeline assets, manage the logistical process and detailed timeline for regulatory submissions, and partner with SMEs across CTD to identify source documents and align the delivery of approved technical documents. The role requires providing input and scientific oversight for content generation for Module 2.3 and 3, and a thorough understanding of source documentation requirements for regulatory submissions and their correlation to the authoring process. You will also review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections, and ensure content clarity and consistency in messaging across the dossier. Additionally, you will facilitate and manage the data verification process, assist with dossier creation and system compliance for regulatory submissions, and coordinate response authoring, review, and data verification for queries from Health Authorities. You will track upcoming submissions and ongoing submission progress, maintain a submission content tracker, and represent Tech Writing and Document Management in cross-functional CMC teams. Collaboration with CMC matrix team leaders and external suppliers is expected to ensure timely submissions. The role also involves supporting and implementing continuous process improvement ideas and initiatives, and training others on procedures, systems access, and best practices, including mentoring and training employees on the document management process. You will work independently under supervision and collaborate with other teams.

Requirements

Bachelor’s degree in Biology or related discipline with a minimum of 2 years’ experience
CMC experience required.
Familiarity with eCTD structure for regulatory submissions is required
Outstanding verbal and writing communication skills
Strong attention to detail
Strong planning skills
Strong organizational skills
Strong negotiating skills
Demonstrated ability for timely delivery.
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
Experience in biotech/pharma e2e product development required.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.

Nice To Haves

Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred
BLA experience is strongly preferred.
Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.

Responsibilities

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 scientific oversight for content generation for Module 2.3 and 3.
Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
Ensures content clarity/ consistency in messaging across dossier.
Facilitate and manage the data verification process.
Assist with dossier creation and system compliance for regulatory submissions
Coordinate response authoring, review and data verification to queries from HA for submissions.
Track upcoming submissions and ongoing submission progress
Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
Represent Tech Writing and Document management in cross-functional CMC teams as required.
Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
Collaborate with external suppliers as needed for CTD content and review.
Support and implement continuous process improvement ideas and initiatives.
Train others on procedures, systems access and best practices as appropriate.
Mentor and train employees on the document management process
Work independently under supervision and collaborate with other teams.