The Planet Group
Job Description
Job Title : CMC Writer Location : Paramus, NJ Contract length : 5 months Schedule : 40 hrs/week (5a to 3:30p), Mon-Thu Pay : $48/hr to $50/hr, DOE
CMC Writer Job Overview: A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs. Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions.
CMC Writer Key Responsibilities
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
CMC Writer Required Qualifications:
Education: Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities Familiarity with global regulatory frameworks and eCTD submissions Excellent technical writing, communication, and organizational skills Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
CMC Writer Preferred Qualifications:
Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings Ability to interpret and apply regulatory guidelines effectively Strong project management and stakeholder communication skills Veeva Vault, Smartsheet are plus
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Job Title : CMC Writer Location : Paramus, NJ Contract length : 5 months Schedule : 40 hrs/week (5a to 3:30p), Mon-Thu Pay : $48/hr to $50/hr, DOE
CMC Writer Job Overview: A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs. Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions.
CMC Writer Key Responsibilities
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
CMC Writer Required Qualifications:
Education: Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities Familiarity with global regulatory frameworks and eCTD submissions Excellent technical writing, communication, and organizational skills Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
CMC Writer Preferred Qualifications:
Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings Ability to interpret and apply regulatory guidelines effectively Strong project management and stakeholder communication skills Veeva Vault, Smartsheet are plus
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.