Documentation Analyst

• Job Title: Documentation Analyst
• Location: New Brunswick, NJ
• Duration: 12 Months with Possible Extension
• Pay Rate: $36.80 - $41.80/ 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 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:
• Manage 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.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, address any grammatical or formatting related comments.
• Facilitate and manage the data verification process.
• Assist with dossier creation and system compliance for regulatory submissions
• Track upcoming submissions and ongoing submission progress
• 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 Bachelors degree in Biology or related discipline with a minimum of 3+ 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)