Documentation Analyst

Job Description

Job Title : Documentation Analyst

Location : New Brunswick, NJ

Duration : 12 Months on W2

Hybrid : (50% onsite)

Work Schedule : Mon-Friday(normal business hours)

Duration : 12 months (High possibility of extension for right candidate depending on performance or budget)

• Job Description :

Documentation Analyst 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.

oManage the logistical process and detailed timeline for scientific and regulatory content creation for clinical and life-cycle CMC regulatory submissions and responses to health authority questions.

oReview and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, address any grammatical or formatting related comments.

oFacilitate and manage the data verification process.

oAssist with dossier creation and system compliance for regulatory submissions

oTrack upcoming submissions and ongoing submission progress

oRepresent Tech Writing and Document management in cross-functional CMC teams as required.

oCollaborate and coordinate with CMC matrix team leaders to ensure timely submissions.

oCollaborate with external suppliers as needed for CTD content and review.

oSupport and implement continuous process improvement ideas and initiatives.

oTrain others on procedures, systems access and best practices as appropriate.

oMentor and train employees on the document management process

oWork independently under supervision and collaborate with other teams.

oRequired Bachelor’s degree in Biology or related discipline with a minimum of 3+ years experience

oFamiliarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.

oFamiliarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.

oOutstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.

oProficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.

oExperience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.

oExperience 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.

oTake ownership of the section – formatting, language check, connections to other sections / tables.

oWorks 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)