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Urgent! Documentation Analyst Job Opening In New Brunswick New Jersey – Now Hiring Sunrise Systems Inc



Job description

Job Title:  Documentation Analyst 

Job ID :  (phone number removed)

Location:  New Brunswick, NJ (50% onsite)

Position Type: Hourly contract Position (W2 only)

 

Description: 50% onsite required

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.

 

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 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.

  • 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 biotech/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, and document management in cell therapy.



The hourly rate for this position is between $40-$42 per hour.



Compensation:

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].



Benefits:

Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees.

We also offer Sick time benefits as required per State regulations.



Required Skill Profession

Other General



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