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 ...
Ridgefield, CT · Remote
$61/hr
Analytical SME & CMC Technical Writer Location: Ridgefield, CT (Fully Remote) Duration ... Contract till July 2027 with possibility to extend Pay rate: $61/hr on W2 Should have experience in ...
Ridgefield, CT · Remote
$61/hr
Analytical SME & CMC Technical Writer Location: Ridgefield, CT (Fully Remote) Duration ... Contract till July 2027 with possibility to extend Pay rate: $61/hr on W2 Should have experience in ...
Lawndale, CA · Hybrid
The Director of CMC must be able to work independently, manage multiple projects, and operate effectively in a lean organization with extensive interaction with external contract research ...
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Lawndale, CA · Hybrid
The Director of CMC must be able to work independently, manage multiple projects, and operate effectively in a lean organization with extensive interaction with external contract research ...
Manage our CMC Contract to include internal financial reporting and performance * Manage our sub-consultant contracts, including staffing and services performed * Prepare dashboard reports including ...
Manage our CMC Contract to include internal financial reporting and performance * Manage our sub-consultant contracts, including staffing and services performed * Prepare dashboard reports including ...
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 ...
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 ...
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 ...
Ridgefield, CT · On-site
$54 - $55.70/hr
This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and ...
Ridgefield, CT · On-site
$54 - $55.70/hr
This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and ...
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.
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.
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 ...
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 ...
$160K - $211K/yr
Acts as regulatory CMC liaison with partner companies and contract manufacturers * Provides expertise in translating regulatory requirements into practical, workable plans * Interacts with regulatory ...
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$160K - $211K/yr
Acts as regulatory CMC liaison with partner companies and contract manufacturers * Provides expertise in translating regulatory requirements into practical, workable plans * Interacts with 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.
Boston, MA · On-site
$210K - $240K/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
$210K - $240K/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 ...
Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents * Evaluate and manage the Technical CMC dossier documentation involved in ...
Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents * Evaluate and manage the Technical CMC dossier documentation involved in ...
... contract manufacturers. * Manage interactions with FDA and other global regulatory authorities for ... Author and lead CMC content for Health Authority meeting briefing packages, including development ...
... contract manufacturers. * Manage interactions with FDA and other global regulatory authorities for ... Author and lead CMC content for Health Authority meeting briefing packages, including development ...
Conway, SC · On-site
This position is posted ONLY for our current QUEST DIAGNOSTIC Contract Employees ... Only CURRENT Quest employees affiliated with CMC need apply for this position.
Conway, SC · On-site
This position is posted ONLY for our current QUEST DIAGNOSTIC Contract Employees ... Only CURRENT Quest employees affiliated with CMC need apply for this position.
$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