- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: MCAAS Finance Leadership Development Program Finance at our Company is committed to developing future leaders through its ... Finance Leadership Development Program (FLDP). Individuals are provided...to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our… more
- Merck & Co. (Rahway, NJ)
- …(10) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the ... (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the… more
- Novo Nordisk Inc. (Boulder, CO)
- …across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Quality Control, Supply Chain, and ... to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Insmed Incorporated (San Diego, CA)
- …operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key areas ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Merck & Co. (Rahway, NJ)
- …and demonstrated experience partnering for Pharmaceutical development / CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and be accountable for results by working in a fast-paced environment.Responsibilities- Leadership , Direction, and Strategy: Leads implementation of Program / ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …to ensure research projects are executed efficiently and effectively, and within budget. Regulatory Oversight: Uphold the highest standards of quality and ... regulatory frameworks and an established history of successfully navigating regulatory challenges; exceptional leadership acumen evidenced by a track record… more
- Merck & Co. (Millsboro, DE)
- …data, documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory ... animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly… more
- Aequor (Thousand Oaks, CA)
- …implements project management processes and methodologies to support the various program Core Teams, including subteams within the Combination Product Operations ... to ensure projects deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such as; needle protection… more
- Merck & Co. (Rahway, NJ)
- …implantable, ophthalmic, and inhaled dosage forms.Provide active strategic and technical leadership on program development teams, interfacing with key ... requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Durham, NC)
- …committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to ... primarily support vaccine drug substance site readiness via Validation program implementation, partnering with cross-functional teams (ie Maintenance, Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ... to plan and accomplish goals specific to the Supplier Quality Program . This position supports the ongoing...in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach and ensures ... the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the… 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 ... for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects.-- Accountability predominantly includes the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and best practices to stakeholders while measuring the KPIs and ROI for each program and reporting progress to leadership Oversee the building and maintenance of ... Novo Nordisk affiliates across North America, senior functional/ LoB leadership teams, Communications, Legal, Talent Acquisition, Finance, Procurement, and other… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... support/technical knowledge for the development/refinement and implementation of the GEP program and validation standards based on risk-based practices as prescribed… more
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