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Job Description SOKOL GxP Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document coordination. The Technical Writer will author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions. This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier. This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed. The ideal candidate will be detail-oriented, organized, deadline-driven, and comfortable working in a fast-paced regulatory submission environment. This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence required and occasional travel to other local New Jersey sites for larger team meetings. Requirements Required Qualifications: • Bachelor’s degree required; Biology or related discipline preferred., • Minimum 2 years of experience in technical writing for Regulatory CMC documentation within the pharmaceutical or biotechnology industry., • Familiarity with eCTD structure for regulatory submissions., • Experience supporting CMC regulatory documentation, dossier creation, and submission timelines., • Cell therapy CMC experience required., • Familiarity with CTD Quality sections, including Module 2.3 and Module 3., • Understanding of source documentation requirements for regulatory submissions and how source documents connect to the authoring process., • Strong verbal and written communication skills., • Strong attention to detail, planning, organizational, and negotiating skills., • Demonstrated ability to deliver high-quality documentation within filing deadlines., • Proficiency with Microsoft Office applications, including Word, Excel, SharePoint, and PowerPoint., • Ability to work independently under supervision and collaborate cross-functionally with scientific, regulatory, project management, and document management teams., • Ability to work in a fast-paced, changing team environment and prioritize multiple tasks. Preferred Qualifications: • BLA regulatory submission experience strongly preferred., • Experience with computer-assisted document preparation tools preferred., • Proficiency in compliance-ready standards for final publication preferred., • Experience in biotech/pharma end-to-end product development preferred., • Experience training others on procedures, systems access, and document management best practices preferred. Benefits Competitive hourly rate, $: 33.03 – 41.95 (W-2, no C2C option) Working hours: Monday to Friday, regular business hours Hybrid position: 50% onsite required Location: New Brunswick, NJ 12-month contract with possibility of extension Occasional travel to other local New Jersey sites for larger team meetings, approximately 2–3 times per year Health insurance, holiday pay, 401(k), referral bonus program

Job DescriptionDescription: Email Marketer / Copywriter Celerant Technology Corporation is a leading provider of premium, advanced retail management software for all types of retail organizations. Our SaaS software, developed in-house, manages all areas of the retail business including store aspects such as point of sale, purchase orders, inventory management, reporting, to all aspects of their online business, such as eCommerce, mobile shopping apps, order fulfillment and digital marketing services. Ranked as the #1 Retail Software Vendor in the 2023 RIS LeaderBoard, we give retailers the tools and services necessary to run their operations both efficiently and profitably. Our clients range from firearms dealers to apparel stores, and everything in between! Feel free to visit our company website for more information at www.celerant.com. Our Marketing Department is looking to add a full-time Email Marketer / Copywriter to the team. This candidate should be well-rounded and capable and/or eager to learn all aspects of marketing, with a primary focus on email marketing and content creation. With our main headquarters in NY and additional offices in CA, GA and TX- this hybrid position will be out of the Staten Island, NY location, both in the office and remote. Position Responsibilities: • Content Creation- Researching and writing engaging content such as email copy, landing pages, blogs, articles, sales sheets, announcements, social posts, newsletters and more., • Messaging- Work with our team on messaging strategy and ensuring strong, on-point messaging for each email and piece of content created., • Email Marketing- Create email marketing campaigns using marketing automation software (Eloqua) to both our client base and prospect base for increased lead generation., • Reporting- Tracking and measuring the success of content marketing efforts, including email marketing, social media engagement, website traffic and more., • On-Site SEO- Using keywords and other techniques to ensure website content is SEO friendly for search engine rankings., • Team Collaboration- Working with marketing team for developing & execution of visual content, marketing campaigns and strategy, plus the sales team as well. Minimum Qualifications: · Bachelor’s Degree · 2 + years of content and/or digital marketing experience • Exceptional communication & writing skills (Webpage copy, blogs, whitepapers etc.) Preferred Qualifications: • Ideal candidates have worked in a CMS platform (preferably WordPress) with applied experience both updating existing pages & designing/creating pages from scratch, • Comfortable working with marketing automation platforms and/or email design tools (Eloqua, HubSpot, Act-On etc.), • Ability to create & edit graphic files using Adobe creative suite, • Working knowledge of HTML & CSS, • Creative, Innovative Individual, • Ambitious, Ability to multi-task Benefits: Competitive salary based on experience; Medical, Dental and Vision coverage; 401(k); PTO; Flexible Spending Account; STD, LTD and Life Insurance. Please include salary requirements and cover letter explaining why you believe you would be a good candidate for this position. Requirements: Minimum Qualifications: · Bachelor’s Degree · 2 + years of content and/or digital marketing experience • Exceptional communication & writing skills (Webpage copy, blogs, whitepapers etc.) Preferred Qualifications: • Ideal candidates have worked in a CMS platform (preferably WordPress) with applied experience both updating existing pages & designing/creating pages from scratch, • Comfortable working with marketing automation platforms and/or email design tools (Eloqua, HubSpot, Act-On etc.), • Ability to create & edit graphic files using Adobe creative suite, • Working knowledge of HTML & CSS, • Creative, Innovative Individual, • Ambitious, Ability to multi-task

Job Description The primary duty of the Customs Entry Writer is to support the Brokerage Team by processing customs clearance documents and filing ISF filings timely and accurately. Since this position is primarily to review, submit and monitor various customs clearance documents, with other duties required, the right candidate must be comfortable working independently while under supervision. Role and Responsibilities : ● Review entry documents for accuracy and communicate documentation discrepancies to supervisor and/or controlling branch if something is missing or incomplete. ● Process various customs clearance documents through the Company’s ABI system, obtaining Customs release and other government agency releases as appropriate and advise interested parties of such releases. ● Provide Entry Summary and Cargo Release documents to appropriate branch. ● Review and monitor all customs rejections, requests for information and any other government agency correspondences and address them timely and appropriately under supervision. ● Must have knowledge of HTSUS & PGA/OGA. ● Maintain and keep current all customs compliance documentation. ● Maintain up-to-date customer records in ABI software system. ● Onboard new client details into the ABI software system. ● File ISF’s in a timely manner. ● Adhere to all company policies, procedures, and guidelines, such as the Code of Conduct, work schedule, and attendance requirements. ● Some Invoicing required. ● Perform other duties as assigned. This position reports to the Licensed Customs Brokerage Manager of the company. Qualifications : ● At Minimum 2-3 years of entry writing experience. ● Ability to Classify and take Customs Bonds ● Familiar with ABI software applications. ● Ability to work with minimal supervision and deliver a high-level service. ● Excellent communication and organizational skills with strong attention to detail. ● Ability to multitask and meet deadlines

Job Description Automotive service writer with experience in ordering parts, customer service and scheduling. Competitive wages, medical, 401K and vacation

Job DescriptionJob Description We are seeking an experienced Import Customs Clearance Specialist to file customs entries in full compliance with U.S. Customs and Partner Government Agency regulations. The ideal candidate will have strong attention to detail, excellent communication skills, and hands-on experience handling customs entries and import documentation in a fast-paced environment. Key Responsibilities · Prepare, review, and submit import customs entries to U.S. Customs and Border Protection (CBP) · Coordinate filings with Partner Government Agencies (FDA, USDA, EPA, Fish & Wildlife Service, etc.) · Transmit customs entries accurately and within regulatory deadlines · Review commercial invoices, packing lists, bills of lading, and related documents for accuracy and compliance · File Importer Security Filings (ISF) and monitor compliance timelines · Receive, review, and process import documentation for assigned accounts · Track and trace shipment documentation (HBLs, invoices, supporting records) · Communicate with customers, overseas agents, freight forwarders, carriers, steamship lines, airlines, trucking companies, and government officials · Resolve customs-related issues including documentation discrepancies, customs exams, FDA holds, and clearance delays · Provide timely updates to internal teams and external customers · Deliver excellent customer service while maintaining compliance with all applicable laws and regulations. Qualifications & Experience · 2–5 years of experience in import customs clearance or international trade operations · Strong knowledge of U.S. Customs regulations and the Harmonized Tariff Schedule (HTS) · Familiarity with Partner Government Agencies (FDA, USDA, EPA, FWS) is a plus · Ability to work independently, multitask, and thrive in a fast-paced environment · Strong problem-solving skills and attention to detail · Excellent written and verbal communication skills · Proficiency in Microsoft Outlook, Excel, Word, and Cargowise (CW1) · Team-oriented, customer-focused mindset. Compensation & Benefits Competitive salary of $55,000–$65,000 annually, based on experience. Opportunities for professional growth and development

Job DescriptionDescription: JESCO is a premier dealer of heavy construction equipment and technology in the Northeast and Mid-Atlantic regions. We proudly represent John Deere, Wirtgen, Kleeman, Vögele, Hamm, Ditch Witch, Magni, Topcon, and many more products for purchase, rental, parts, and service. Family-owned and operated for more than 50 years, we are hiring to grow our award-winning company! Why JESCO: Join a growing team with a lucrative opportunity in equipment sales. Driven sales professionals will have the ability to achieve uncapped commissions. Apply today and start a long term career with the Down to Earth Equipment People of JESCO! Basic Function Responsible for providing administrative assistance in coordination with other service department personnel and in accordance with the established guidelines of the company. Responsibilities • Receive and handle all incoming calls; customer, internal, and manufacturers’ representatives, and determine what calls should have messages taken, and what calls are passed through to service manager., • Provide Warranty support as needed., • Close internal sales work orders, submit PDI check lists, and match warranty credit memos to invoices., • Process payroll for service department, including billing time cards for field service., • Create and process all service department purchase orders. Follow purchase order until manager’s approval., • Handle service department vendors not directly billed on work orders, such as office supplies, generators, waste stream, tooling purchases, and shop supplies., • Assume responsibility of cashier: responsible for processing all C.O.D. Payments, including checks and credit cards., • Maintain service department records, including work orders, filing or archiving, DOT records, personnel jackets, PM contracts and the like., • Warranty process: Run monthly reports and notify rental manager of expiration status. Notify customer through certified letters of warranty status., • Prepare and process extended warranty, including all paperwork, electronic submission, and payment, • Planned maintenance: process paperwork and invoicing for PM maintenance plans for both one-time and repetitive billings., • Assist service manager in maintaining manufacturers’ Product Improvement Programs with regard to customer contract, scheduling, locations unknown, and SIS processes., • Maintain all service department correspondence under the direction of Product Support Manager and both Service Managers., • Individuals must comply with all safety requirements and be able to lift and move up to 70 lbs., • Make yourself available for overtime, understanding that the equipment repair business may call for it from time to time, • Actively communicates, assists and reports to both field and shop service managers., • Continually report to the product support manager any problems encountered with customer satisfaction, employee relations, or product performances.Requirements:, • Oral Communication, • Written Communication, • Technical Communication, • Reading, • Computer Literacy, • Customer Relations, • Diplomacy, • Professionalism, • Math Aptitude, • Organization, • Planning, • Time Management Education/Training/Licenses Associate’s Degree or Equivalent Valid Driver’s License – Must meet underwriting requirements Experience Prior service management and/or customer service experience helpful. We are an equal opportunity employer and prohibit discrimination/harassment 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.

JOB TITLE: Technical writer Location: New Brunswick, NJ (50% Onsite) Duration: 12 months initial (potential extension/potential right to hire) Work Schedule: normal business hours Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year) Job Description The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program. 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. o Primary Responsibilities: o Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. o Plan and facilitate submission kick-off for clinical regulatory submissions. o Manage the logistical process and detailed timeline for regulatory submissions. o Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy. o Provide input and scientific oversight for content generation for Module 2.3 and 3. o Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. o Ensure content clarity/ consistency in messaging across dossier. o Facilitate and manage the data verification process. o Assist with dossier creation and system compliance for regulatory submissions o Coordinate response authoring, review and data verification to queries from HA for submissions. o Track upcoming submissions and ongoing submission progress o Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. o Represent Tech Writing and Document management in cross-functional CMC teams as required. o Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions. o Collaborate with external suppliers as needed for submission content and review. o Support and implement continuous process improvement ideas and initiatives. o Train others on procedures, systems access and best practices as appropriate. o Mentor and train employees on the document management process o Work independently under supervision and collaborate with other teams. o Competencies & Experiences o Bachelor's degree or equivalent in Biology or related discipline with a minimum of 2 years' experience (4-7 years for senior level). o Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required. o Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. o Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. o Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. o Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. o 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. o Take ownership of the section – formatting, language check, connections to other sections / tables. o Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy and GPS organization. If hired, you will enjoy the following Eclaro Benefits: • 401k Retirement Savings Plan administered by Merrill Lynch, • Commuter Check Pretax Commuter Benefits, • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com or call (212)804-7476. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Quality - Technical Writer Job Number: 26-00813 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Quality - Technical Writer for our client in New Brunswick, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program. 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. Work effectively in cross-functional project teams to accomplish company goals. Responsibilities: Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. Plan and facilitate submission kick-off for clinical regulatory submissions. Manage the logistical process and detailed timeline for regulatory submissions. Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy. Provide input and scientific oversight for content generation for Module 2.3 and 3. Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. Ensure content clarity/ consistency in messaging across dossier. Facilitate and manage the data verification process. Assist with dossier creation and system compliance for regulatory submissions Coordinate response authoring, review and data verification to queries from HA for submissions. Track upcoming submissions and ongoing submission progress Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. 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 submission 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. Required Qualifications: Bachelor's degree or equivalent in Biology or related discipline with a minimum of 2 years' experience (4-7 years for senior level). 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 and GPS organization. Pay Rate: $42.85-$45.45/Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 2128047476 June Binuya | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

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A renowned institution for higher education in New Brunswick is seeking two experienced videographers and an experienced photographer to capture and edit content for the upcoming RAD Symposium.Responsibilities include managing equipment, capturing high-quality photos and videos, and collaborating wi

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A leading environmental services company is seeking a Product Development Lab Tech in Plainfield, NJ to provide support to laboratory personnel.

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