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Job Title: Documentation Analyst

Hours/Schedule: Mon- Fri/ business hours

Compensation: $32.91 - $41.80

Type: Contract

Overview

Leading pharmaceutical company looking for an experienced Documentation Analyst. Ideal candidates should have a Bachelors degree and at least 2 years of experience in Regulatory CMC documentation within the pharmaceutical or biotechnology industry; Familiarity with eCTD structure for regulatory submissions.

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.

Requirements

+ 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 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.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.