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 ...
Waltham, MA · On-site
$300 - $340/hr
VP, CMC Korsana Biosciences, Inc. Waltham, Massachusetts, United States About this positionAbout Us ... Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management.
Waltham, MA · On-site
$300 - $340/hr
VP, CMC Korsana Biosciences, Inc. Waltham, Massachusetts, United States About this positionAbout Us ... Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management.
... contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts * Support the Associate Director, CMC ...
... contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts * Support the Associate Director, CMC ...
Waltham, MA · On-site
$300 - $340/hr
Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management ... Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA ...
Waltham, MA · On-site
$300 - $340/hr
Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management ... Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA ...
Waltham, MA · On-site
$300K - $340K/yr
Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management ... Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA ...
Waltham, MA · On-site
$300K - $340K/yr
Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management ... Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA ...
South San Francisco, CA · On-site
$50/hr
Reporting to the Manager, Clinical Supply Chain, the contract CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and ...
South San Francisco, CA · On-site
$50/hr
Reporting to the Manager, Clinical Supply Chain, the contract CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and ...
... 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 ...
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 ...
Reporting to the Manager, Clinical Supply Chain, the contract CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and ...
Reporting to the Manager, Clinical Supply Chain, the contract CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and ...
Irving, TX · On-site
$66K - $80K/yr
Active member of the Contract Management Council (CMC) ensuring requests from various businesses across the enterprise meet the standards established by the CMC. * Provide guidance and options when ...
Irving, TX · On-site
$66K - $80K/yr
Active member of the Contract Management Council (CMC) ensuring requests from various businesses across the enterprise meet the standards established by the CMC. * Provide guidance and options when ...
OR · On-site +1
As the Director, CMC Programs, you will play a critical role in overseeing a team of CMC program ... Partner with contract manufacturers to create and maintain effective relationships. Serve as the ...
New
OR · On-site +1
As the Director, CMC Programs, you will play a critical role in overseeing a team of CMC program ... Partner with contract manufacturers to create and maintain effective relationships. Serve as the ...
New
Los Alamos, NM · On-site
$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 · On-site
$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 ...
Active member of the Contract Management Council (CMC) ensuring requests from various businesses across the enterprise meet the standards established by the CMC. * Provide guidance and options when ...
Active member of the Contract Management Council (CMC) ensuring requests from various businesses across the enterprise meet the standards established by the CMC. * Provide guidance and options when ...
Waltham, MA · On-site
$78K - $95K/yr
... contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts * Support the Associate Director, CMC ...
Waltham, MA · On-site
$78K - $95K/yr
... contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts * Support the Associate Director, CMC ...
Cambridge, MA · On-site
$140K - $190K/yr
The Primary Job Responsibilities 1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech. 2) Support Head of ...
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Cambridge, MA · On-site
$140K - $190K/yr
The Primary Job Responsibilities 1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech. 2) Support Head of ...
The CMC Programs team will be responsible for coordinating and delivering CMC activities in line ... Partner with contract manufacturers to create and maintain effective relationships. Serve as the ...
New
The CMC Programs team will be responsible for coordinating and delivering CMC activities in line ... Partner with contract manufacturers to create and maintain effective relationships. Serve as the ...
New
Cambridge, MA · On-site
$140K - $190K/yr
The Primary Job Responsibilities 1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech. 2) Support Head of ...
Quick apply
Cambridge, MA · On-site
$140K - $190K/yr
The Primary Job Responsibilities 1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech. 2) Support Head of ...
$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 ...
$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.
Cities with the most Cmc Contract job openings:
The most popular types of Cmc jobs are:
States with the most job openings for Cmc Contract jobs include:
The top searched job categories for Cmc Contract jobs are:

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