Documentation Analyst

Job Description

Job Summary:

• 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.

Duties and 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.

Education & Experiences:

• Required Bachelor’s 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.
• 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.

Knowledge, Skills and Abilities:

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