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Job Description About the Role: We are seeking a detail-oriented Entry Writer to support international freight operations by preparing accurate and timely customs documentation. In this role, you will ensure compliance with U.S. Customs regulations while coordinating with clients, carriers, and internal teams to facilitate the smooth movement of goods across borders. Responsibilities: • Prepare and submit customs entries and related import/export documentation., • Review commercial invoices, bills of lading, certificates of origin, and other shipping paperwork., • Classify goods using the Harmonized Tariff Schedule (HTS) and applicable regulatory codes., • Communicate with clients, vendors, carriers, and internal teams to resolve documentation issues., • Monitor shipment status and maintain accurate compliance records and audit trails., • Calculate duties, taxes, and fees; provide guidance to clients regarding potential costs., • Advise on customs procedures, INCOTERMS, and shipment requirements., • Utilize customs brokerage and ISF software to prepare submissions and track shipments., • Highly detail-oriented with strong organizational skills; able to manage multiple shipments simultaneously., • Experience with customs brokerage software and Microsoft Office Suite., • Strong verbal and written communication skills., • Ability to interpret and apply U.S. customs regulations., • Experience in logistics, freight forwarding, or customs brokerage preferredopen to entry-level candidates willing to learn., • Health, dental, and vision insurance, • Retirement savings options, • Paid time off and company holidays, • Opportunities for training, skill development, and career advancement

Job Description Entry Writer / Data Entry & PGA Specialist Location: Moonachie, NJ | Full-Time | ✈️ Logistics Are you detail-oriented, organized, and ready to take the next step in your logistics career? Join our team as an Entry Writer, where you’ll play a key role in ensuring smooth import operations, compliance with regulations, and outstanding service to our clients. What You’ll Do Responsibilities: • Review and organize import files to ensure all information and documentation is accurate and complete., • Communicate with Customer Service when additional documents or information are needed from clients., • Classify documentation based on operations system data and follow client-specific SOPs., • Support the Import Manager with classification and compliance needs., • Research and provide HTS or product codes when missing, ensuring accuracy for future use., • Input entry data and handle FDA (PGA) requirements, including “may proceed” releases., • Immediately notify clients when FDA exams are required (document or merchandise)., • Prepare and annotate delivery orders with FDA release status., • Issue written instructions to carriers/steamship lines when shipments must be held for release., • Ensure shipments are properly released once clearance is completed., • Pass completed files to Post-Entry team for final assembly., • Monitor releases by Customs, FDA, and other authorities, and resolve census or entry errors., • High School Diploma or GED required., • 3+ years of entry writing and/or brokerage operations experience (data entry & PGA focus)., • Experience with CargoWise One preferred; QuestaWeb a plus., • Strong knowledge of U.S. and international geography (countries, cities, ocean ports)., • Proficiency in Microsoft Outlook, Word, and Excel., • Ability to work independently while delivering top-quality customer service., • Excellent attention to detail, organization, and multitasking skills. We know our success depends on our people. That’s why we offer a competitive benefits package designed to support your health, well-being, and future: • Medical, Dental, and Vision Insurance, • Health Savings Account (HSA) – 100% employer-paid, plus $1,000 annual employer contribution, • Short-Term Disability Insurance – 85% of base pay, • Long-Term Disability Insurance – 60% of base pay, • Life Insurance & AD&D Coverage – $25,000 each, • 401(k) with Profit Sharing (annual contribution if eligible) We are more than just an international logistics provider—we are a proudly independent, innovative leader in supply chain solutions and global trade compliance. With a commitment to excellence, we offer exceptional opportunities for career advancement and personal development in both trade compliance and business development. Our mission is clear: to deliver the highest standard of customer service, competitive pricing, and value-added services that truly set us apart in the industry. What distinguishes us is not only what we do, but how we do it—with integrity, efficiency, and a forward-thinking approach that drives success for our clients and our team.About Our Company\r\n\r\nWe are more than just an international logistics provider—we are a proudly independent, innovative leader in supply chain solutions and global trade compliance.\r\n\r\nWith a commitment to excellence, we offer exceptional opportunities for career advancement and personal development in both trade compliance and business development. Our mission is clear: to deliver the highest standard of customer service, competitive pricing, and value-added services that truly set us apart in the industry.\r\n\r\nWhat distinguishes us is not only what we do, but how we do it—with integrity, efficiency, and a forward-thinking approach that drives success for our clients and our team.

Job Description SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

Job Description Our client is seeking a CMC Writer to join their team. & SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. JOB DESCRIPTION: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files KEY RESPONSIBILITIES: • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies. QUALIFICATIONS: • Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint). PREFERRED SKILLS: • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities., • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies., • Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)., • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.