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Job Description SOKOL GxP Services is hiring a Technical Writer – CMC Regulatory Submissions to support our client’s team in New Brunswick, NJ. This hybrid role will be part of the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). As a key contributor, you will be responsible for preparing CMC documentation, including dossiers and supporting materials, that shape the regulatory strategy for the Cell Therapy clinical portfolio — spanning from early-stage development through registrational filings. This role offers the opportunity to collaborate closely with subject matter experts across Process Development, Analytical Development, Technical Operations, Quality, and Regulatory Sciences, ensuring high-quality, timely submissions that advance transformative therapies to patients. Key responsibilities include: • Author and co-author CMC content for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy., • Plan and lead submission kick-offs, managing detailed timelines, deliverables, and cross-functional collaboration., • Coordinate and track submissions, including responses to Health Authority questions, data verification, and final dossier preparation., • Partner with subject matter experts (SMEs) across CTDO to identify source documents, align on timelines, and deliver approved technical content., • Ensure consistency, clarity, and accuracy of messaging across all CMC documentation., • Review and reconcile comments with SMEs, manage revisions, and facilitate efficient comment resolution., • Provide oversight for eCTD Modules 2.3 and 3, ensuring compliance with formatting, structure, and regulatory requirements., • Collaborate with external partners as needed to review and finalize CTD content., • Drive process improvements and contribute to best practices in regulatory writing and document management. Bachelor’s degree in Biology or a related discipline; advanced degree preferred. Minimum 2 years of experience in biotech or pharma, with a focus on end-to-end product development. Strong knowledge of regulatory requirements and guidance for CMC documentation; cell therapy CMC experience required. Familiarity with eCTD structure and BLA submissions strongly preferred. Exceptional scientific writing and editing skills with strong attention to detail. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint); experience with document preparation tools and compliance-ready standards. Excellent planning, organizational, and communication skills, with the ability to manage multiple priorities in a fast-paced environment. Proven ability to work independently while thriving in cross-functional team settings. Benefits Competitive hourly rate: $34 – $44/hr (W-2 only, no C2C) Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (PTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company

Job Description Technical Order Writer About CompoSecure Founded in 2000, CompoSecure (NYSE: CMPO) is a technology partner to market leaders, fintechs and consumers enabling trust for millions of people around the globe. The company combines elegance, simplicity, and security to deliver exceptional experiences and peace of mind in the physical and digital world. CompoSecure's innovative payment card technology and metal cards with Arculus security and authentication capabilities deliver unique, premium branded experiences, enable people to access and use their financial and digital assets, and ensure trust at the point of a transaction. For more information, please visit and . Position Overview: The Technical Order Writer is an entry-level responsible for assisting in the creation and release of Engineering Masters and Work Orders. These documents guide the planning and processing of orders for the Supply Chain and Prototype Team. The role involves documenting operation steps, instructions, and material needs, while working closely with various departments to ensure accuracy and consistency. The Technical Order Writer will be expected to work on-site five days a week in our Somerset, NJ office. Key Responsibilities: Documentation • Help create and distribute Finished Goods Parts documentation., • Attend team meetings to understand special processing or material needs., • Use Visual software to assist in creating and reviewing Engineering Masters and Work Orders., • Support the release of documentation to Supply Chain, Prototype Team, Engineering Teams, and Quality Control., • Record and implement standard practices and updates., • Understand and support Part ID creation., • Assist in reviewing and applying changes to Engineering Masters and Work Orders based on Engineering Change Notices (ECNs) or email instructions., • Help distribute updated documents to relevant teams., • Develop/Follow documentation process to make updates., • Ability to navigate various screens within the ERP system to make updates. Other Important Responsibilities • Follow company policies and safety procedures., • Manage basic email communications related to documentation., • Conform to department best practices., • Create/Attend Meetings as necessary., • Perform other tasks assigned. Qualifications: • Associate's degree (bachelor's degree preferred)., • 0–2 years (or more) of experience in a technical writing or manufacturing support role., • Familiarity with Visual Database systems is a plus., • Experience in a manufacturing environment is a plus., • Basic proficiency in Microsoft Office Suite., • Familiarity with Workflow software is a plus., • Strong written and verbal communication skills., • Detail-oriented with a willingness to learn and self-review work., • Ability to manage time and prioritize tasks effectively., • Enthusiastic attitude, cooperative team player, adaptable to a highly dynamic environment, professional demeanor, sensitive to client needs, self-motivated, creative and innovative., • Capable of working in an office setting for extended periods., • Frequent use of computer, phone, and office equipment., • Moderate noise level in office environment. Physical requirements and work environment • Must be able to lift 20 lbs;, • Must be able to sustain office work for 8+ hours per day including:, • Sitting in an office chair or walking through the shop, • Typing, and sight for computer use., • Reaching for the telephone, hearing for phone use, • Office environment is of moderate noise level. At CompoSecure, we believe in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to: • Medical, Dental & Vision Coverage, • Flexible Spending Accounts (FSA), • Company-Paid Life and Disability Insurance, • 401(k) with Company Match, • Paid Time Off & Paid Holidays, • Annual Bonus Opportunities, • Employee Assistance Program (EAP) Please note: CompoSecure does not accept unsolicited resumes from staffing agencies or third-party recruiters. Any unsolicited resumes sent to CompoSecure, including to our employees, will become the property of CompoSecure and may be used without any obligation to pay referral or placement fees. Any agency or recruiter seeking to work with CompoSecure's Talent Acquisition Team should contact our team directly by sending an email to . CompoSecure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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Grant Writer & Partnership Coordinator.

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