Edison-New Brunswick Metro Area, NJ
The CMC Regulatory Technical Writer works closely with quality, manufacturing, regulatory, and technical staff from global locations within company s industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 CMC regulatory submissions for development and post-approval dossiers in eCTD format. The CMC Regulatory Technical Writer also authors change controls, following company s change control procedures.
The technical writer contributes to various US, EU and rest of world (ROW) registrations. They author and create dossier content from source documentation for registrations, and provide writing support for technical reports. Recommend table of contents for regulatory submissions. Contribute to regulatory strategy for successful product registration. Assess questions received from health authorities and author responses. Ensure all dossiers are in compliance with company s templates, regulatory guidance, and ICH guidance, and maintain up to date knowledge. Maintain skills required for dossier related software systems.
The candidate must possess substantial Chemistry, Manufacturing and Controls (CMC) and Common Technical Document (CTD) authoring experience. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have at least 7 years' experience in the industry. Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is mandatory. A working knowledge of cGMP s is desired. Experience with CMC documentation pertinent to various dosage forms is needed.
This position requires the incumbent to be highly organized, self-motivated, and able to independently manage multiple priorities. The desired candidate will have the capacity to be productive with very little supervision, and should enjoy writing. Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact with a multi-disciplinary team. Knowledge of US pharmaceutical regulations is essential. Exposure to non-US regulatory activities is desired, but not mandatory.