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Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants. Title: Documentation Analyst Duration: 12months Location: 100% Remote (Eastern Time Shift) Pay: 35.00 - 36.00/hr on w2 (All Inclusive) Scope of Position: Technical Writing and Document Management This is a fully remote role Work Schedule: Mon - Fri, Business Hours Job Description: Technical Writing and Document Management (TDM) function is responsible for delivering CMC documentation (Dossier and supporting documents) to support regulatory strategy for Cell therapy portfolio from early stage through life cycle management. Responsibilities: Document Specialist supports the documentation activities for regulatory submission content and supporting documentation for cell therapy portfolio. This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Development, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals. Manage the logistical process and detailed timeline for CTD Quality sections aligned with scientific/regulatory content creation for clinical, commercial, and lifecycle CMC regulatory submissions and responses to health authority questions. Assist with dossier creation and system compliance for regulatory submissions. Manage dossier content and agency questions delivery timelines aligned with global CMC submission timelines. Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. Support SMEs with document editing for compliance with Client authoring style guide, Core template. Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, GRS CMC, management). Facilitate data verification activities. Participate in initiatives involved with regulatory filings. Participate in various crossfunctional project teams, interact with SMEs, regulatory and other key partners both internal and external to the company as necessary. Must possess the ability to support multiple projects simultaneously. Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers. Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines. Works independently under supervision and collaborates with other teams. Trains others on procedures as appropriate. Bachelor's degree or equivalent in relevant discipline with a minimum of 2 years' experience (47 years for senior level). Familiarity with eCTD structure for regulatory submissions is required. Outstanding verbal and writing communication skills, attention to detail, strong planning, organizational and negotiating skills, with focus on timely delivery. Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred. Experience with regulatory documentum software is required along with proficiency in compliance ready standards for final publication is a strong asset. Must be capable of working in a fastpaced changing team environment, prioritizing multiple tasks to meet filing deadlines. Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions. Additional Job Requirements: None Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond. Equal Employment Opportunity Statement: Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Vacancy expired!