- Merck & Co. (Rahway, NJ)
- …first-in-class or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is accelerated; has an external business ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (Rahway, NJ)
- …clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently ... Job DescriptionPosition Description: Senior Principal Scientist, Biostatistics (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a distinguished… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …they may partner with the Local and Global Clinical Operations, regulatory affairs, medical affairs, legal, communications, compliance , etc. Externally, ... diversity of trial populations, inform strategies for improvement, and ensure compliance with regulatory requirements Physical Requirements 10-20% overnight… more
- Genmab (Plainsboro, NJ)
- …proactively and in response to requests for information, consistent with promotional compliance and regulatory requirementsDevelops and maintains a network of ... As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/Head of US… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Technically independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the ... an FDA, EMEA, GMED or TGA regulated production facility Knowledge of GMPs, Compliance and Regulatory requirements is essential Excellent communication skills and… more
- Aequor (Thousand Oaks, CA)
- …defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets. Co-Leads the ... implements project management processes and methodologies to support the various program Core Teams, including subteams within the Combination Product Operations… more
- Merck & Co. (North Wales, PA)
- …and communication as neededFacilitate the integration between marketing / promotion, legal/ regulatory and technical teams to ensure compliance with channel ... Leadership, Account Executive Leadership, US Market Operations, IT, Training, Compliance , Legal, and Communications.-Key responsibilities of the Digital Channel SME,… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Novo Nordisk Inc. (Boulder, CO)
- …associated with aseptic processing Experience working to standards required for regulatory compliance of Aseptic Processing facilities Understanding of ... across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Quality Control, Supply Chain, and Clinical… more
