- Insmed Incorporated (Bridgewater, NJ)
- … management regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy.Author nonclinical sections in regulatory ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director, Toxicology is a key member of the… more
- Merck & Co. (Rahway, NJ)
- …LATAM and APAC. Leads site EHS leaders and influences site, region and global business partners to drive prioritization of regulatory compliance, continuous ... collaborative relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Catalent (San Diego, CA)
- Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Aequor (Thousand Oaks, CA)
- …level engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, ... of 5-8 YOE in project management within R&D and regulatory affairs, within pharmaceutical. Not a tech expert but...and be able to establish progress monitoring, manage the program leadership team's work and do schedule analysis to… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… 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 ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …questions for optimizing model-based development-Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... chemical entities and biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on… more
- Eisai, Inc (NJ)
- …reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...Statistical programming, Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... other research areas centered around rare diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's… 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 benefit of patients and global human health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... will include, but not necessarily be limited to, the following: Works with global cross‐functional team to ensure that trials are conducted in adherence to study… 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)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department's Government Accountability … more
- Merck & Co. (Rahway, NJ)
- …chemistry, biopharmaceutics, material science, process development, and/or engineering and regulatory science.Proven ability to lead program development teams ... Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research… more
- Merck & Co. (Rahway, NJ)
- …or related areas of study.Required:Minimum of 10 years of experience in a senior role such as Marketing, Global meetings, events, experiential marketing or ... Job DescriptionDescription of PositionThe Global Commercial and Digital Experience (CDX) team is...attention but also generate high-quality leads. Collaborating closely with senior stakeholders, they will craft and implement strategies with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations function, as well as ensuring close collaboration with other areas of Global Development and US Clinical, Medical and Regulatory (CMR). Your skills, ... About the Department The East Coast Hub is the next stage of our Global Development ambitions within the US. Within the Global Development organization this is a… more
