- Kelly Services (Rahway, NJ)
- …OF POSITION** The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical ... in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review...preparation and review of information required for development of regulatory CMC dossiers for new and existing… more
- Merck (Rahway, NJ)
- …supplies. + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... and packaging activities as well as supply chain documentation to support critical CMC activities. + Responsible for authoring the Clinical Supplies section of the… more
- Merck (Rahway, NJ)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... the information that they need. + Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects.… more