CMC Writer
CMC Writer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Title: CMC Writer
Job Location: Paramus NJ
Job Type: Contract
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
- Author and review CMC sections of regulatory submissions including IND NDA and MAA applications.
- Ensure documents align with FDA EMA and ICH regulatory requirements.
- Work closely with scientists regulatory affairs teams and manufacturing experts to gather accurate data.
- Maintain consistency clarity and accuracy in technical writing.
- Help establish regulatory CMC submission processes and procedures.
Employment Type
Full-time
