CMC Documentation Analyst - Cell Therapy (Hybrid, New Brunswick, NJ)

CMC Documentation Analyst Cell Therapy (Hybrid, New Brunswick, NJ)

We are seeking a CMC Documentation Analyst Cell Therapy for our global pharmaceutical client. YOU will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). The focus of this role is to deliver CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite at the client's office in New Brunswick, NJ

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

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
  
  
  
  

Requirements:

• 2+ years of experience in Regulatory CMC documentation within the pharmaceutical or biotechnology industry

• Cell therapy CMC experience required.

• Familiarity with eCTD structure for regulatory submissions

• Proficiency in 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.

• Take ownership of the section formatting, language check, connections to other sections / tables.

• Bachelor's degree in Biology is required.

Please submit your resume to our network at (please apply to the CMC Documentation Analyst Cell Therapy (Hybrid, New Brunswick, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $38/hr. - $41.80/hr.

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