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Ctd Writer Jobs (NOW HIRING)

CMC Writer

Paramus, NJ ยท On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents ... Authoring and review of CMC submission components and documentation in CTD to support regulatory ...

CMC Writer

Paramus, NJ ยท On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract ... Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD ...

Principal Medical Writer

Durham, NC ยท On-site

$100 - $125/hr

Principal Medical Writer ViiV Healthcare, a global specialty HIV company, is seeking a Principal ... Experience leading regulatory submission projects, including Common Technical Document (CTD ...

Expert Regulatory Writer

Distant, PA ยท On-site +1

$151K - $226K/yr

Provide content and strategic expertise for clinical portions of the CTD. * Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned ...

CMC Writer

Paramus, NJ ยท On-site

$45 - $50/hr

CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type ... Authoring and review of CMC submission components and documentation in CTD to support regulatory ...

Writes and/or edits clinical documents for submission to the FDA and other regulatory agencies. Is ... Develops SOPs and templates for the CTD, protocols, final reports, Annual Reports, and IBs. Skills ...

$125 - $150/hr

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

New

Principal Medical Writer

Durham, NC ยท On-site

$125 - $150/hr

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

New

Principal Medical Writer

Durham, NC ยท On-site

$125 - $150/hr

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to ... Experience leading regulatory submission projects, including Common Technical Document (CTD ...

Senior Principal Medical Writer

Billerica, MA ยท On-site

$126K - $215K/yr

Solid CTD/CTD-like knowledge; experience across multiple markets is a plus. * Excellent written and verbal English; strong presentation and collaboration skills. * Ability to travel as needed.

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

Experience leading regulatory submission projects, including Common Technical Document (CTD ... Proven ability to independently write and manage complex regulatory documents. * Strong ...

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Ctd Writer information

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How much do ctd writer jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for ctd writer in the United States is $46.27, according to ZipRecruiter salary data. Most workers in this role earn between $33.65 and $56.01 per hour, depending on experience, location, and employer.

What are popular job titles related to Ctd Writer jobs?

For Ctd Writer jobs, the most frequently searched job titles are:

CMC Writer

Paramus, NJ โ€ข On-site

Staffingine LLC
Recruiting and Staffing Servicesย โ€ขย 51 - 200 employees

Contractor

Re-posted 24 days ago


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.