CMC Writer
Paramus, NJ · 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 format. * Manage timelines and deliverables ...
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CMC Writer
Paramus, NJ · 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 format. * Manage timelines and deliverables ...
CMC Writer
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...
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CMC Writer
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...
CMC Writer
Paramus, NJ · On-site
$45 - $50/hr
CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...
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CMC Writer
Paramus, NJ · On-site
$45 - $50/hr
CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...
Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing ...
Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing ...
Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing ...
Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing ...
CMC dossier leader
Waltham, MA · On-site
Understanding of regulatory documents for milestones, agency consultations, site inspections, and written responses to information requests. * Knowledge of CMC dossier structures for clinical trial ...
CMC dossier leader
Waltham, MA · On-site
Understanding of regulatory documents for milestones, agency consultations, site inspections, and written responses to information requests. * Knowledge of CMC dossier structures for clinical trial ...
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
CMC Regulatory Manager
Morristown, NJ · On-site
CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is ... Excellent writing skills * Demonstrated ability/experience managing IT based scientific systems ...
CMC Regulatory Manager
Morristown, NJ · On-site
CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is ... Excellent writing skills * Demonstrated ability/experience managing IT based scientific systems ...
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
Quick apply
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
CMC Regulatory Manager
Morristown, NJ · On-site
CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is ... Excellent writing skills * Demonstrated ability/experience managing IT based scientific systems ...
CMC Regulatory Manager
Morristown, NJ · On-site
CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is ... Excellent writing skills * Demonstrated ability/experience managing IT based scientific systems ...
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory ... Strong written and verbal communication skills, with the ability to translate technical information ...
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory ... Strong written and verbal communication skills, with the ability to translate technical information ...
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a ...
The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high ... Proficiency in Mandarin Chinese (spoken and written) is highly desirable * Proficient user of ...
The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high ... Proficiency in Mandarin Chinese (spoken and written) is highly desirable * Proficient user of ...
Director CMC Regulatory
South San Francisco, CA · On-site
$180K - $237K/yr
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies #J-18808-Ljbffr
Director CMC Regulatory
South San Francisco, CA · On-site
$180K - $237K/yr
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies #J-18808-Ljbffr
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies Salary Range: $230,000 to $270,000 Powered by JazzHR p5RFBEBp7g
Quick apply
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies Salary Range: $230,000 to $270,000 Powered by JazzHR p5RFBEBp7g
Director, CMC Regulatory
San Francisco, CA · On-site
$230K - $270K/yr
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies Salary Range: $230,000 to $270,000 #J-18808-Ljbffr
Director, CMC Regulatory
San Francisco, CA · On-site
$230K - $270K/yr
Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies Salary Range: $230,000 to $270,000 #J-18808-Ljbffr
Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
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Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Excellent technical writing and document preparation skills with demonstrated experience authoring ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Excellent technical writing and document preparation skills with demonstrated experience authoring ...
Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
Associate Director, CMC Regulatory
Seattle, WA · On-site
$190K - $230K/yr
Strong oral and written communication skills * Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams * Ability to multi-task as needed in ...
Cmc Writer information
See salary details
$11.78 - $14.58
7% of jobs
$14.58 - $17.37
11% of jobs
$18.13 is the 25th percentile. Wages below this are outliers.
$17.37 - $20.17
24% of jobs
The median wage is $21.48 / hr.
$20.17 - $22.97
16% of jobs
$22.97 - $25.76
14% of jobs
$26.38 is the 75th percentile. Wages above this are outliers.
$25.76 - $28.56
8% of jobs
$28.56 - $31.36
7% of jobs
$31.36 - $34.16
4% of jobs
$34.16 - $36.95
3% of jobs
$36.95 - $39.75
2% of jobs
$39.75 - $42.55
2% of jobs
$11
$24
$42
How much do cmc writer jobs pay per hour?
As of Sep 13, 2026, the average hourly pay for cmc writer in the United States is $24.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.51 and $27.88 per hour, depending on experience, location, and employer.
What is a CMC writer?
CMC Writers, or Chemistry, Manufacturing, and Controls Writers, are professionals who prepare documentation related to the manufacturing processes, quality control, and regulatory compliance of pharmaceutical products. They create and compile the CMC sections of regulatory submissions such as INDs, NDAs, and MAAs required by regulatory agencies like the FDA and EMA. Their work ensures that all technical information about drug substances and products is clearly documented, compliant with regulations, and ready for review by health authorities.
What are the key skills and qualifications needed to thrive as a CMC writer?
To thrive as a CMC Writer, you need a solid background in chemistry, pharmaceuticals, or life sciences, often supported by a relevant degree and experience in regulatory writing. Familiarity with regulatory submission formats (such as CTD), document management systems, and guidelines from agencies like the FDA or EMA is critical. Strong attention to detail, excellent written communication, and the ability to collaborate across scientific and regulatory teams are vital soft skills. These competencies ensure the accurate and compliant preparation of technical documents necessary for successful product approvals and lifecycle management.
What are some common challenges faced by CMC writers when preparing regulatory submissions?
CMC Writers often encounter challenges related to gathering and synthesizing complex scientific and technical data from cross-functional teams, such as analytical, formulation, and manufacturing experts. Keeping up with frequently changing regulatory requirements and ensuring documentation consistency across submissions can also be demanding. Effective communication and strong organizational skills are essential to manage tight deadlines and maintain high-quality, compliant documentation throughout the drug development process.
What is the difference between Cmc Writer vs Regulatory Writer?
| Aspect | Cmc Writer | Regulatory Writer |
|---|---|---|
| Credentials | Typically requires a degree in life sciences or related field; certifications are a plus | Requires similar degrees; often benefits from regulatory affairs certifications |
| Work Environment | Pharmaceutical or biotech companies, focusing on chemistry, manufacturing, and control documentation | Regulatory agencies or consulting firms, focusing on compliance and submission documents |
| Industry Usage | Commonly used in biotech and pharma for CMC documentation | Used across industries for regulatory submissions and compliance |
While both roles involve scientific writing, Cmc Writers focus specifically on chemistry, manufacturing, and control documentation within biotech and pharma companies. Regulatory Writers have a broader scope, handling various regulatory documents for compliance and submissions across industries. The roles often overlap but differ mainly in scope and focus area.
What states have the most Cmc Writer jobs?
States with the most job openings for Cmc Writer jobs include:
What are popular job titles related to Cmc Writer jobs?
For Cmc Writer jobs, the most frequently searched job titles are:
CMC Writer
Paramus, NJ • On-site
Staffingine LLC
• Recruiting and Staffing Services • 51 - 200 employees51 - 200 employees
Contractor
Re-posted 29 days ago
Job description
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.
About Staffingine
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Atlanta, GA, US
Year founded
2016