- Novo Nordisk Inc. (Plainsboro, NJ)
- …innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the ... advanced degree is strongly preferred Minimum of 10 years drug development /FDA/ regulatory related industry experience required Demonstrated knowledge of 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)
- …to 20% overnight travel required; May require occasional work outside of standard business hours to support special requests/events. Development of People Ensure ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across ... maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying up-to-date… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …our products. The Finance and Operations team works closely with the business across the organization to guide enterprise wide resource allocations, investment ... facilities and assure the integrity and completeness of all business transactions. At Novo Nordisk, you will have the...dedication with the opportunity for continuous learning and personal development . Are you ready to realize your potential? The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …serious chronic diseases. As part of the team, you will contribute to the development and delivery of our portfolio vision, business strategies, and tactical ... who need them most. The Position Accountable for the development and execution of patient centric strategic and tactical...tactical plans to drive the achievement of Brand Marketing business objectives with a focus on optimizing the patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …serious chronic diseases. As part of the team, you will contribute to the development and delivery of our portfolio vision, business strategies, and tactical ... new, innovative/emerging channels to reach and influence customers and future-proof the business in an ever-evolving landscape. Manages an aggregate budget of over… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference? The Position This position supports ... OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... these findings to relevant cross-functional stakeholders, to help inform future DS regulatory / development strategies, activities and ways of working. This role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...transition of rising star early assets to late phase development , based on the vision for the function. As… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development… more
- Tris Pharma (Monmouth Junction, NJ)
- …planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development , Regulatory Affairs, Manufacturing, Quality, etc. to identify, ... potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to provide input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late-stage compounds Involvement with in-licensing ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and work-flow management.Manage employee direct reports and associated employee development duties.Depending on business priorities, manage contractor-based ... contracted activities utilizing both performance and quality measurements.The Associate Director , SCBM Financial Reporting & Strategy position provides leadership in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Area; Reviews content to be shared with KEEs; Frequent involvement in Business Development activities for late stage compounds; Involvement with in-licensing ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates ... (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills.Responsibilities- Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of ... templates across categories for RFPs, rate card analytics, MSA standardization of business terms. Influence and forms strong partnerships with business leaders… more
