CMC writer

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.

Job Type: Contract

Pay: $46.23 per hour

Schedule:

• 8 hour shift

Application Question(s):

• Are you a U.S Citizen?

Experience:

• CMC (Chemistry, Manufacturing, and Controls) Writer: 3 years (Required)
• pharmaceutical or regulatory writing: 3 years (Required)

Work Location: In person

Salary : $46