Job Description

Job Title: Technical Writer

Location: New Brunswick, NJ

Duration: 12 Months with Possible Extension

Pay Rate: $41.29 - $44.29/ hr on W2

50% onsite required

Work Schedule: Mon-Friday (normal business hours)

Job Description

• :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. 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 submission
• sCoordinate response authoring, review and data verification to queries from HA for submissions
• .Track upcoming submissions and ongoing submission progres
• sMaintain 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 proces
• sWork independently under supervision and collaborate with other teams

.Competencies & Experiences

• :Required Bachelors degree in Biology or related discipline with a minimum of 2 years experienc
• eFamiliarity 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

.Trave l

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

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