drjobs CMC Writer CMC Writer Paramus, NJ

CMC Writer CMC Writer Paramus, NJ

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1 Vacancy
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Job Location drjobs

Paramus, NJ - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

CMC Writer Chemistry Manufacturing and Controls Regulatory Drug Development Manufacturing and Quality Control NDA/MAA CTD EU (IMPD and MAA) US-FDA FDA

If you post this job on a job board please do not use company name or salary. Experience level: Mid-senior Education level: Bachelors degree Job function: Health Care Provider Industry: Pharmaceuticals Pay rate : Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No

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: Bachelors 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.

Employment Type

Full Time

Company Industry

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