CMC Dossier Authors

Top 10 Pharmaceutical Company with a location in Hopewell NJ is seeking 4-6 CMC Dossier Authors to join their team. Compensation is commensurate with experience and education. Description: These persons will provide global CMC dossier authoring services at BMS New Jersey facilities (Hopewell, NJ). These individuals will provide knowledgeable and experienced in the preparation of global CMC dossiers in the CTD format. Ability to work independently and within a team environment. Must demonstrate the ability to research and prepare CMC information, in CTD format, for submission to global health authorities. Deliverables will include assigned work activities, on currently marketed products, related to the preparation of Annual Product Reports, Product Renewals and post-approval submissions i.e. MAA Variations and NDA supplements resultant from change control activities.

 Requirements: Substantial knowledge of worldwide health authority regulations is necessary. (US, EU, Canada, Australia, Japan, South Africa) Good technical writing and communication skills. Knowledge of the pharmaceutical manufacturing and quality environments. Ability to learn and work within Client Documentum authoring systems, e.g CARA. Ability to learn and work with database systems. Experienced working within Microsoft Word and document management systems.