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CMC Writer

Paramus, NJ 07652

Posted: 07/25/2025 Employment Type: Contract Job Category: Technical Writer Job Number: 24915 Workplace Type: On-Site

Job Description


A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control.

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
  • Project management skill is plus
Key Responsibilities
  • 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.
  • Process Improvement: Help establish regulatory CMC submission processes and procedures.
Requirement
  • Strong technical writing, analytical, and regulatory knowledge.
  • In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions, manufacturing processes, analytical methods, specifications, formulation development, test method validation, process validation, and packaging validation.  Familiar with a variety of regulatory guidelines, technical processes, and procedures related to CMC development activities. Strong planning and organizational skills with demonstrated ability to deliver work on time. Excellent written and communication skills.  Proficient in the use of Microsoft Office Suite including Word, Excel, Outlook 365 and Access.
Qualifications
  • Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field.
  • Experience: Prior experience in pharmaceutical or regulatory writing is preferred.


Compensation: $50/hour
We look forward to reviewing your application. We encourage everyone to apply - even if every box isn’t checked for what you are looking for or what is required.

PDSINC, LLC is an Equal Opportunity Employer.
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About Paramus, NJ

Discover exciting job opportunities in the vibrant area around Paramus, New Jersey! Nestled in Bergen County, Paramus is a dynamic hub offering a perfect blend of urban convenience and suburban charm. Known for its proximity to the bustling Paramus Park Mall and the lush Saddle River County Park, this region boasts a thriving job market with endless possibilities for professional growth. With easy access to cultural attractions like the Bergen Performing Arts Center, a wide array of dining options ranging from classic diners to upscale restaurants, and just a short drive to catch a game at MetLife Stadium, Paramus is the perfect place to kickstart your career. Explore our job listings today and take your career to new heights in this exciting locale!