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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 Job Summary: We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulatory medical writing and a strong background in drafting essential regulatory documents, including Investigator’s Brochures (IBs), briefing books, responses to regulatory inquiries, and clinical study reports (CSRs). Additionally, this role will be responsible for leading contract medical writers, ensuring consistency, quality, and alignment with AMA and regulatory requirements. Responsibilities: • Author and edit high-quality regulatory documents, including IBs, briefing books, CSRs, and responses to regulatory authorities., • Lead and mentor contract medical writers, providing guidance, oversight, and quality assurance in regulatory document development., • Ensure regulatory compliance by following industry standards, guidelines, and best practices., • Collaborate cross-functionally with clinical, regulatory, and scientific teams to ensure clarity and accuracy in submissions., • Manage timelines and oversee document preparation schedules to meet regulatory submission deadlines., • Implement strategic input provided by the regulatory team to ensure alignment with strategy within and across content of documents., • Review and QC documents for consistency, scientific accuracy, and regulatory alignment. Qualifications: • Bachelor’s degree in life sciences (a higher degree such as Master’s, Ph.D., or PharmD is preferred)., • 4-8 years of experience in regulatory and/or clinical medical writing within the pharmaceutical or biotech industry., • Strong leadership skills with prior experience leading medical writers., • Deep knowledge of AMA style guide requirements., • Excellent writing and editing skills with the ability to convey complex scientific information clearly and concisely., • Detail-oriented with strong organizational skills to manage multiple projects simultaneously., • Proficiency in Microsoft Word and other document management tools (StartingPoint templates, Veeva RIM, etc)., • Expertise in writing and managing complex regulatory submission documents for clinical development programs., • Strong understanding of medical terminology and clinical trial methodology. This role is ideal for an experienced regulatory medical writer looking to take on leadership responsibilities while driving key regulatory submissions. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $96,000 to $150,000 USD

Exceptional writing, editing, and proofreading skills with an eye for detail. Experience in writing for various platforms, including websites, blogs, social media, and email campaigns. Writing clear marketing copy to promote our products, services, and events.

Develop and deliver strategic content for key meetings, reviews, and communications that support decision-making and stakeholder engagement. Proven expertise in crafting narratives, structuring presentations, and designing story-driven content for executive audiences is required. Manager, PMO Strate

Develop and deliver strategic content for key meetings, reviews, and communications that support decision-making and stakeholder engagement. Proven expertise in crafting narratives, structuring presentations, and designing story-driven content for executive audiences is required. Manager, PMO Strate

Technical Writer - Operations Labeling Group. Develop and maintain labeling instructions for use / Method Sheets (IFU / MS), Ensure labeling content is accurate, clear, and consistent with regulatory and company global standards. Minimum of 3 years experience as a technical writer, preferably within

Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. Collaborate with external suppliers as needed for CTD content and review. The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strat

Technical Writer - Operations Labeling Group. Develop and maintain labeling instructions for use / Method Sheets (IFU / MS), Ensure labeling content is accurate, clear, and consistent with regulatory and company global standards. Minimum of 3 years experience as a technical writer, preferably within