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Open nowFirst seen 37 hours ago

CMC Writer

5 Star1,197 open roles

Where
Paramus, New Jersey, United States
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Your applicationOpen nowCMC Writer5 Star · Paramus, New Jersey, United States

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The clock on this job

Early applications get read.

11.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.9%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: first seen 37 hours ago

The posting

SUMMARY:

  • 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.

QUALIFICATIONS:

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.
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