- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy ... and provide regulatory oversight for assigned products in order to optimize product labeling and obtain shortest time to approval by regulatory agencies.You will… more
- Eisai, Inc (Nutley, NJ)
- … Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for...well as providing strategic product direction to project teams on interacting and negotiating… more
- J&J Family of Companies (Raritan, NJ)
- …at** **https://www.jnj.com/innovative-medicine** **We are searching for the best talent for a Director , Investigational Product Preparation and Strategy ... to ensure consistent program deliverables including the development/authoring of the investigational product preparation and administration instructions… more
- J&J Family of Companies (Raritan, NJ)
- …**https://www.jnj.com/innovative-medicine** **We are searching for the best talent for an Associate Director , Investigational Product Preparation and ... Strategy.** Beerse, Belgium - Requisition Number: R-016743 Associate Director , Investigational Product Preparation and Strategy **.** This is a remote… more
- HonorHealth (AZ)
- …safe and effective use of investigational drugs. Provides oversight over investigational drug product dose preparation and dispensing. Provides oversight ... of investigational drug services across the pharmacy enterprises. The Pharmacy Director in the area of Investigational Drugs will oversee clinical,… more
- J&J Family of Companies (Spring House, PA)
- …define necessary training strategy and deliver investigational product preparation instructions. * Collaborates with the Director , GCO Learning & ... deploying training strategy and delivery across clinical trial, specific to investigational product preparation /administration and role-based training… more
- University of Utah Health (Salt Lake City, UT)
- …internal customers, protocol-specific requirements, IV medication compounding instructions, Investigational Product accountability, receipt and destruction of ... with clinical trial protocols, support drug distribution actives including preparation of both IVs (including chemotherapy) and retail prescriptions,... investigational product , quarantine of investigational product ,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** The Director , Product & Pipeline Communications, will serve as a leader within Otsuka's Corporate Communications & Marketing team and a strategic ... partner to Otsuka's cross-functional US and global teams. The Director will lead product and pipeline communications for Otsuka's currently marketed products,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug ... guidance and play a critical role overseeing the strategy, preparation , and submission of high‑quality INDs, CTAs, and original...and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic… more
- Boehringer Ingelheim (Ridgefield, CT)
- …primary liaison to FDA concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is...IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These… more
