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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[510,520,532,542,557],{"_429":428,"_434":511,"_452":453,"_444":445,"_243":512,"_441":513,"_427":428,"_111":514,"_431":194,"_433":194,"_454":453,"_442":515,"_425":516,"_455":456,"_430":130,"_476":477,"_460":517,"_478":514,"_479":515,"_481":482,"_483":518,"_485":519},["D",1771236000000],"Job Description:

CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA,

If you post this job on a job board, please do not use company name or salary. Experience level: Mid-senior Education level: Bachelors degree Job function: Health Care Provider Industry: Pharmaceuticals Pay rate : Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No

SUMMARY:\nA 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.\nJOB DESCRIPTION:

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.\nSupport the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions\nAuthoring 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\nEnsure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.\nObtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.\nAssess and communicate potential regulatory risks and propose mitigation strategies\nUnderstands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.\nIdentify, communicate and escalate potential CMC regulatory issues, as needed\nHelp establish regulatory CMC submission processes and procedures.\nFamiliar with eCTD format submission files\nProject management skill is plus\nKEY RESPONSIBILITIES:

Regulatory Documentation:

Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.\nCompliance & Guidelines:

Ensure documents align with FDA, EMA, and ICH regulatory requirements.\nCollaboration:

Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.\nQuality Assurance:

Maintain consistency, clarity, and accuracy in technical writing.\nProcess Improvement:

Help establish regulatory CMC submission processes and procedures.\nQUALIFICATIONS:

Education:

Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field.

Experience:

Prior experience in pharmaceutical or regulatory writing.\nCMC (Chemistry, Manufacturing, and Controls) Writer experience.

Working Place:

Paramus, New Jersey, United States

Company :

ESR Healthcare\n","Job Description:

CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA...","CMC Writer CMC Writer Paramus, NJ $$$ bonus","Paramus, New Jersey, us, 07653",["B","2591551813"],"/jobs/2591551813-cmc-writer-cmc-writer-paramus-nj-bonus","/jobs?location=Paramus%2C+New+Jersey%2C+us%2C+07653","/jobs?keyword=CMC+Writer+CMC+Writer+Paramus%2C+NJ+%24%24%24+bonus",{"_429":428,"_434":521,"_452":453,"_444":522,"_243":438,"_441":438,"_427":428,"_111":523,"_431":432,"_433":194,"_454":453,"_442":524,"_425":525,"_455":526,"_430":130,"_476":527,"_460":528,"_478":523,"_479":524,"_481":529,"_483":530,"_485":531},["D",1771027200000],"Katalyst Healthcares and Life Sciences","Regulatory CMC Writer","Hackensack, NJ, US, 07601",["B","2619530320"],"Work at Katalyst Healthcares and Life Sciences","5 days ago","/jobs/2619530320-regulatory-cmc-writer","/jobs?keyword=Katalyst+Healthcares+and+Life+Sciences","/jobs?location=Hackensack%2C+NJ%2C+US%2C+07601","/jobs?keyword=Regulatory+CMC+Writer",{"_429":428,"_434":533,"_452":453,"_444":534,"_243":438,"_441":438,"_427":428,"_111":535,"_431":432,"_433":194,"_454":453,"_442":443,"_425":536,"_455":537,"_430":130,"_476":538,"_460":539,"_478":535,"_479":443,"_481":540,"_483":484,"_485":541},["D",1771372800000],"C. Winchell Agency, Inc.","Brokerage Specialist",["B","2619554707"],"Work at C. Winchell Agency, Inc.","1 days ago","/jobs/2619554707-brokerage-specialist","/jobs?keyword=C.+Winchell+Agency%2C+Inc.","/jobs?keyword=Brokerage+Specialist",{"_429":428,"_434":543,"_452":453,"_444":544,"_243":545,"_441":546,"_427":428,"_111":547,"_431":194,"_433":194,"_454":453,"_442":548,"_425":549,"_455":550,"_430":130,"_476":551,"_460":552,"_478":553,"_479":548,"_481":554,"_483":555,"_485":556},["D",1771467331000],"Sharecare","A leading digital health company in Trenton, NJ is seeking a Proposal Writer responsible for developing proposal content that meets compliance and quality standards. The ideal candidate will have experience in the healthcare sector and proposal writing, ensuring timely and persuasive submissions while collaborating across teams. Strong communication and organizational skills are essential for this role.\n#J-18808-Ljbffr","A leading digital health company in Trenton, NJ is seeking a Proposal Writer responsible for developing proposal content that meets compliance and ...","Strategic Proposal Writer: Health Tech RFP Specialist Job at Sharecare in Trento","Trenton, NJ, US, 08628",["B","1888556852"],"Work at Sharecare","1 hours ago","/jobs/1888556852-strategic-proposal-writer-health-tech-rfp-specialist-job-at-sharecare-in-trento","Strategic Proposal Writer: Health Tech RFP Specialist Job at Shar...","/jobs?keyword=Sharecare","/jobs?location=Trenton%2C+NJ%2C+US%2C+08628","/jobs?keyword=Strategic+Proposal+Writer%3A+Health+Tech+RFP+Specialist+Job+at+Shar...",{"_429":428,"_434":558,"_452":453,"_444":559,"_243":560,"_441":561,"_427":428,"_111":562,"_431":194,"_433":194,"_454":453,"_442":563,"_425":564,"_455":565,"_430":130,"_476":566,"_460":567,"_478":562,"_479":563,"_481":568,"_483":569,"_485":570},["D",1770724515000],"Cardinal Health","A leading healthcare provider in the U.S. seeks a Senior Medical Writer to develop clinical documents and support product evaluation and compliance. The candidate will have a strong background in medical writing, project management, and regulatory guidelines, with an emphasis on compliance with EU regulations. This role involves preparing Clinical Evaluation Reports and working closely with cross-functional teams. Competitive salary and comprehensive benefits package offered.
#J-18808-Ljbffr","A leading healthcare provider in the U.S. seeks a Senior Medical Writer to develop clinical documents and support product evaluation and compliance...","Remote Senior Medical Writer – Regulatory Submissions & CERs","WorkFromHome",["B","2534068057"],"Work at Cardinal Health","8 days ago","/jobs/2534068057-remote-senior-medical-writer-regulatory-submissions-cers","/jobs?keyword=Cardinal+Health","/jobs?location=WorkFromHome","/jobs?keyword=Remote+Senior+Medical+Writer+%E2%80%93+Regulatory+Submissions+%26+CERs","actionData","errors"]