Service writer [h1.location_city]
[job_alerts.create_a_job]
Service writer • yonkers ny
[last_updated.last_updated_1_day]
Our client is seeking a CMC Writer to join their team.Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global ...[show_more][last_updated.last_updated_variable_days]![CMC Writer [1300]](https://cdn-logos.talent.com/v1/logo/image?feedcode=lensa-us&company_name=SkyElia)
Location : Paramus, NJ (onsite).Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.This...[show_more][last_updated.last_updated_variable_days]
Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.This range is provided by Horizon Air Freight.
Your actual pay will be based on your skills and experie...[show_more][last_updated.last_updated_variable_days]
Job Title : Lead Technical Trainer / Writer.Job Category : Direct FLSA : Exempt.Reports To : Manager, Technical Manuals and Training Dept : Technical Publications.
Kawasaki Rail Car - Yonkers, NY.Leads Ka...[show_more][last_updated.last_updated_variable_days]
Strategic Customer Success Manager.We're looking for a Strategic Customer Success Manager to lead AI powered transformation for our Fortune 50 customers in the CPG industry.This role is designed fo...[show_more][last_updated.last_updated_30]
Hybrid – Paramus, New Jersey, 07652.Monday to Friday, 8 : 00 AM – 5 : 00 PM.Position Overview We are seeking an experienced.
This role blends technical writing expertise with project management capabili...[show_more][last_updated.last_updated_1_day]
Maintenance Shop Service Writer.Transdev in Bronx, NY is hiring a Maintenance Shop Service Writer.The Service writer ensure efficient vehicle maintenance scheduling and manage orders.We are looking...[show_more][last_updated.last_updated_30]
Your First Year Income Potential : - $125K+!.We are growing & in need of Advisors immediately !.Those with Service Advisor Experience are encouraged to apply!.
Jeep Dodge Ram is HIRING NOW for friend...[show_more][last_updated.last_updated_30]
Automotive Service Advisor / Writer - CALL NOW ! 214-227-7177 !.[show_more][last_updated.last_updated_30]
Automotive Service Writer Job Duties : Initiates automotive services and repairs by ascertaining performance probl...[show_more][last_updated.last_updated_30]
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
A Pharmaceutical CMC (Chemistry, Manufactur...[show_more][last_updated.last_updated_variable_days]
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 ...[show_more][last_updated.last_updated_variable_days]
Job Title : Senior Entry Writer – Customs Brokerage.Great Neck, NY 11021 (On-site preferred).This individual must be able to work independently, manage full-cycle customs entry processing, and...[show_more][last_updated.last_updated_30]
Automotive Service Writer Job Duties : Initiates automotive services and repairs by ascertaining performance proble...[show_more][last_updated.last_updated_30]
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.Prepar...[show_more][last_updated.last_updated_30]
Review and organize import files to ensure all information and documentation is accurate and complete.Communicate with Customer Service when additional documents or information are needed from clie...[show_more][last_updated.last_updated_variable_days]
DARCARS Lexus of Englewood .Automotive Service Advisor / Writer.Automotive Service Advisor / Writer.In addition, you will build rapport with customers to promote customer satisfaction and cust...[show_more][last_updated.last_updated_30]
A company is looking for a Technical Writer to collaborate on producing high-quality documentation for transportation-related projects.
Key Responsibilities Proofread and edit technical documents ...[show_more][last_updated.last_updated_30]
Are you passionate about making a difference in the world? Look no further!.The Borgen Project is an international organization that works at the political level to improve living conditions for pe...[show_more][last_updated.last_updated_variable_days]
- [promoted]
CMC Writer
HireReady PartnersParamus, NJ, US[job_card.full_time]
CMC Writer [1300]
SkyEliaParamus, NJ, United States[job_card.full_time]
Import Specialist - Entry Writer
Horizon Air Freight IncInwood, NY, United States[job_card.full_time]
- [promoted]
Lead Technical Trainer / Writer
Carter Lard ConsultingYonkers, NY, United States[job_card.full_time]
- [promoted]
Strategic customer success manager, CPG
WriterBronx, NY, US[job_card.full_time]
CMC Writer
Suna SolutionsParamus, NJ, United States[job_card.full_time]
Fleet Maintenance Service Writer
TransdevBronx, NY, United States[job_card.full_time]
Automotive Express Service Advisor / Writer
South Shore Chrysler Dodge Jeep Ram of Five TownsNassau County, NY, US[job_card.full_time]
- [promoted]
Automotive Service Advisor / Writer | Up to $110k
AutoShop RecruitingYonkers, NY, US[job_card.full_time]
- [promoted]
Automotive Service Writer
TradeJobsWorkForce10032 New York, NY, US[job_card.full_time]
CMC Writer
TekwissenParamus, NJ, United States[job_card.full_time]
CMC Writer
The Planet GroupParamus, NJ, United States[job_card.full_time]
- [promoted]
Senior Entry Writer
FreightTAS LLCGreat Neck, NY, US[job_card.full_time]
- [promoted]
Automotive Service Writer
TradeJobsWorkforce10033 New York, NY, US[job_card.full_time]
- [promoted]
CMC Writer
Staffingine LLCParamus, New Jersey, USA[job_card.full_time]
- [promoted]
Customs Entry Writer
Coda SearchStaffingBergen County, NJ, United States[job_card.full_time]
- [promoted]
Automotive Service Advisor / Writer
DARCARS Automotive GroupEnglewood, NJ, US[job_card.full_time]
Technical Writer
VirtualVocationsYonkers, New York, United States[job_card.full_time]
Writer / Journalist Internship
The Borgen ProjectBronx, NY, United States[job_card.part_time] +1
CMC Writer
HireReady PartnersParamus, NJ, US[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_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. 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 Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines. Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions. Assess and communicate potential regulatory risks and propose mitigation strategies Understands, 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. Identify, communicate and escalate potential CMC regulatory issues, as needed Help establish regulatory CMC submission processes and procedures. Familiar with eCTD format submission files Project management skill is plus 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. 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). Veeva Vault, Smartsheet are plus 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.
Job Description
Job Description
Our client is seeking a CMC Writer to join their team.
SUMMARY :
- 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.
JOB DESCRIPTION :
KEY RESPONSIBILITIES :
QUALIFICATIONS :
PREFERRED SKILLS :