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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 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 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.