CMC Writer
Paramus, NJ · On-site
Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with ...
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Paramus, NJ · On-site
Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with ...
Quick apply
Paramus, NJ · On-site
Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with ...
Paramus, NJ · On-site
Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and ...
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Paramus, NJ · On-site
Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and ...
Bothell, WA · On-site
$99K - $133K/yr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Bothell, WA · On-site
$99K - $133K/yr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Hill International is seeking a Program Director - Transportation in Orlando, Florida Program Director for the Central Florida Expressway Authority Construction Management Consultant Contract (CMC)
Hill International is seeking a Program Director - Transportation in Orlando, Florida Program Director for the Central Florida Expressway Authority Construction Management Consultant Contract (CMC)
Paramus, NJ · On-site
$45 - $50/hr
Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents ...
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Paramus, NJ · On-site
$45 - $50/hr
Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents ...
Bothell, WA · On-site
$88.10 - $100.05/hr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Bothell, WA · On-site
$88.10 - $100.05/hr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
... CMC experience. Contract length: 12 months with the chance to extend. Pay Range $70/hr. - $80/hr. Shift/Hours Monday-Friday; Remote: EST hours Requisition Disclaimer This job posting is for a ...
... CMC experience. Contract length: 12 months with the chance to extend. Pay Range $70/hr. - $80/hr. Shift/Hours Monday-Friday; Remote: EST hours Requisition Disclaimer This job posting is for a ...
$75 - $85/hr
Los Alamos, NM | Remote Compensation: $75-$85 hr Schedule: 1-Year Contract Citizenship: U.S ... You'll own the CMC build-out, configure it to support existing on-premises Strategy reports and ...
$75 - $85/hr
Los Alamos, NM | Remote Compensation: $75-$85 hr Schedule: 1-Year Contract Citizenship: U.S ... You'll own the CMC build-out, configure it to support existing on-premises Strategy reports and ...
Los Alamos, NM · Remote
$75 - $85/hr
Los Alamos, NM | Remote Compensation: $75-$85 hr Schedule: 1-Year Contract Citizenship: U.S ... You'll own the CMC build-out, configure it to support existing on-premises Strategy reports and ...
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Los Alamos, NM · Remote
$75 - $85/hr
Los Alamos, NM | Remote Compensation: $75-$85 hr Schedule: 1-Year Contract Citizenship: U.S ... You'll own the CMC build-out, configure it to support existing on-premises Strategy reports and ...
Charleston, WV · Remote
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
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Charleston, WV · Remote
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with ... Experience supporting Small Molecule programs required Contract length: 12 months with the chance ...
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with ... Experience supporting Small Molecule programs required Contract length: 12 months with the chance ...
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capitals investments * Participate in business ...
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Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capitals investments * Participate in business ...
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Quick apply
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Configure the new CMC environment to support existing on-premises Strategy reports, dashboards ... of contracts in the environmental, nuclear, and defense sectors. Some reasons to join GEM are:
Configure the new CMC environment to support existing on-premises Strategy reports, dashboards ... of contracts in the environmental, nuclear, and defense sectors. Some reasons to join GEM are:
San Diego, CA · On-site
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
San Diego, CA · On-site
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: * Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area ...
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Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: * Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area ...
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and Regulatory ...
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and Regulatory ...
$17.07 - $20
19% of jobs
$20.52 is the 25th percentile. Wages below this are outliers.
$20 - $22.92
33% of jobs
$22.92 - $25.85
19% of jobs
$26.78 is the 75th percentile. Wages above this are outliers.
$25.85 - $28.78
12% of jobs
$28.78 - $31.71
7% of jobs
$31.71 - $34.64
4% of jobs
$34.64 - $37.57
1% of jobs
$37.57 - $40.49
1% of jobs
$40.49 - $43.42
1% of jobs
$43.42 - $46.35
1% of jobs
$46.35 - $49.28
1% of jobs
$17
$26
$49
| Aspect | Cmc Contract | Cmc Coordinator |
|---|---|---|
| Required Credentials | Typically requires a degree in life sciences or related field, with experience in contract management | Usually requires a degree in life sciences, with some experience in project coordination or administration |
| Work Environment | Works primarily in legal, regulatory, or contract management departments within biotech or pharma companies | Works in project teams, supporting CMC activities in pharmaceutical or biotech settings |
| Employer & Industry Usage | Commonly employed in pharmaceutical, biotech, and contract research organizations | Found in similar industries, often supporting CMC teams in drug development |
The main difference is that a Cmc Contract focuses on managing and negotiating contracts related to CMC activities, while a Cmc Coordinator handles the coordination and administrative support within CMC projects. Both roles require familiarity with CMC processes, but their responsibilities and focus areas differ.

Job Title: CMC Writer
Job Location: Paramus, NJ
Job Type: Contract
Job Description:
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.
Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
Collaborate with cross-functional teams to gather accurate technical information.
Identify and communicate potential regulatory risks; propose mitigation strategies.
Support process improvement initiatives for CMC submission workflows.
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Recruiting and staffing services
51 - 200 Employees
Atlanta, GA, US
2016