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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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 ...
Quick apply
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 ...
Paramus, NJ · On-site
Maintain consistency, clarity, and accuracy in technical writing. * Help establish regulatory CMC submission processes and procedures.
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Paramus, NJ · On-site
Maintain consistency, clarity, and accuracy in technical writing. * Help establish regulatory CMC submission processes and procedures.
Paramus, NJ · On-site
$45 - $50/hr
Strong technical writing, analytical, and regulatory knowledge. * In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions ...
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Paramus, NJ · On-site
$45 - $50/hr
Strong technical writing, analytical, and regulatory knowledge. * In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions ...
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 ...
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 ...
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 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 Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is ... Excellent writing skills * Demonstrated ability/experience managing IT based scientific systems ...
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
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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
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 ...
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 ...
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 ...
San Francisco, CA · On-site
$230 - $270/hr
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
San Francisco, CA · On-site
$230 - $270/hr
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
Cary, NC · Remote
As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry ... strong written and verbal communication skills in English * Strong computer skills, including ...
Cary, NC · Remote
As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry ... strong written and verbal communication skills in English * Strong computer skills, including ...
Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents ...
Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents ...
$153K - $202K/yr
Effective written and verbal communication skills and interpersonal skills. * A collaborative, high ... CMC-related labeling impacts across regions. * Prior experience in oncology product ...
$153K - $202K/yr
Effective written and verbal communication skills and interpersonal skills. * A collaborative, high ... CMC-related labeling impacts across regions. * Prior experience in oncology product ...
Morristown, NJ · Remote
$153K - $202K/yr
This individual will be responsible for providing global regulatory CMC support throughout the ... and written communication skills. Altimmune provides equal employment opportunities to all ...
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Morristown, NJ · Remote
$153K - $202K/yr
This individual will be responsible for providing global regulatory CMC support throughout the ... and written communication skills. Altimmune provides equal employment opportunities to all ...
This role involves coordinating and preparing CMC sections of regulatory submissions to support ... Effective written and verbal communication skills and excellent interpersonal skills. Preferred ...
This role involves coordinating and preparing CMC sections of regulatory submissions to support ... Effective written and verbal communication skills and excellent interpersonal skills. Preferred ...
King Of Prussia, PA · On-site
Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Exceptional oral and written communication skills, with a strong ability to negotiate, influence ...
King Of Prussia, PA · On-site
Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Exceptional oral and written communication skills, with a strong ability to negotiate, influence ...
South San Francisco, CA · On-site
$245K - $285K/yr
This includes developing and leading regulatory CMC strategies and activities for a complex cell ... Track and report on Medical Writing and Regulatory Operations projects, timelines, and key ...
South San Francisco, CA · On-site
$245K - $285K/yr
This includes developing and leading regulatory CMC strategies and activities for a complex cell ... Track and report on Medical Writing and Regulatory Operations projects, timelines, and key ...
Morristown, NJ · On-site
$154K - $204K/yr
Manages all aspects of regulatory CMC activities, assists in the development of regulatory ... Excellent oral and written communication skills. Altimmune provides equal employment opportunities ...
Morristown, NJ · On-site
$154K - $204K/yr
Manages all aspects of regulatory CMC activities, assists in the development of regulatory ... Excellent oral and written communication skills. Altimmune provides equal employment opportunities ...
$245K - $285K/yr
This includes developing and leading regulatory CMC strategies and activities for a complex cell ... Track and report on Medical Writing and Regulatory Operations projects, timelines, and key ...
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$245K - $285K/yr
This includes developing and leading regulatory CMC strategies and activities for a complex cell ... Track and report on Medical Writing and Regulatory Operations projects, timelines, and key ...
$5.29 - $11.63
0% of jobs
$11.63 - $17.96
18% of jobs
$18.95 is the 25th percentile. Wages below this are outliers.
$17.96 - $24.30
47% of jobs
$24.30 - $30.64
7% of jobs
$32.54 is the 75th percentile. Wages above this are outliers.
$30.64 - $36.98
10% of jobs
$36.98 - $43.31
5% of jobs
$43.31 - $49.65
5% of jobs
$49.65 - $55.99
3% of jobs
$55.99 - $62.33
0% of jobs
$62.33 - $68.66
0% of jobs
$68.66 - $75
4% of jobs
$5
$30
$75
| Aspect | Cmc Writing | Medical Writing |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, chemistry, or related field; often certifications in pharmaceutical writing | Degree in life sciences, healthcare, or related; certifications like AMWA or DIA often preferred |
| Work Environment | Pharmaceutical companies, biotech firms, contract research organizations (CROs) | Pharmaceutical companies, medical communication agencies, CROs |
| Industry Usage | Focuses on Chemistry, Manufacturing, and Controls documentation for drug approval | Encompasses clinical study reports, regulatory documents, and scientific publications |
In summary, Cmc Writing specializes in regulatory documentation related to drug manufacturing and chemistry, while Medical Writing covers a broader range of clinical and scientific communication. Both roles require similar credentials and often work within the pharmaceutical industry, but they focus on different aspects of drug development and documentation.
Cities with the most Cmc Writing job openings:
States with the most job openings for Cmc Writing jobs include:
The top searched job categories for Cmc Writing 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