CMC Documentation Specialist - Cell Therapy Submissions

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 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. Travel : Occasionally to other local NJ sites for larger team meetings. (2-3 times a year) 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) This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb . The starting hourly compensation for this assignment is the following range ($38- $41.80/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change. About ASK Consulting ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers. Benefits ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law. Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws. California Applicant Notice ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting View email address on click.appcast.io. Fair Chance Employment Notice If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer. To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process. This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration. #J-18808-Ljbffr Bristol Myers Squibb