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Integrated Resources

Integrated Resources is hiring: Technical Writer in New Brunswick

Integrated Resources, New Brunswick, NJ, US, 08933

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Job Title: Technical Writer
Location: New Brunswick, NJ - 50% Remote role
Duration: 12 Months+ (Possibility of Extension)

Pay rate: $44.29/Hr. On w2

Job Description:
  • The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO).
  • This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
  • This role requires effective collaboration across technical functions to deliver on timelines for submissions.
  • The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO.
  • The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

Primary Responsibilities:
  • Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to 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 CTDO 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.
  • Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
  • 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.

Competencies & Experiences:
  • Required Bachelor's degree in Biology or related discipline with a minimum of 2 years' experience
  • Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
  • Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
  • Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
  • Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
  • Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
  • Experience in bio tech/pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
  • Take ownership of the section - formatting, language check, connections to other sections / tables.
  • Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.

Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)

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