- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory … more
- Merck & Co. (Rockville, MD)
- …Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company's business goals, developing wider ... business goals.-Our GRPI team responsibilities include:Developing and delivering world-class regulatory policy service for all business segments and… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... are emerging leaders in the field of quantitative drug development , with a developing understanding of the strategic elements...communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS)...transition of rising star early assets to late phase development , based on the vision for the functionAs the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... 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
- Merck & Co. (North Wales, PA)
- …project work, the Associate Director is expected to contribute to ongoing business process improvement and talent development in Global Project and Alliance ... Job DescriptionThe drug development Project Manager is part of Global Project...organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and execution across markets ... pipeline of new products and initiatives providing customer benefits and driving business growth.A range of our current portfolio are leaders within their respective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Merck & Co. (Rahway, NJ)
- …affairs, regulatory affairs, manufacturing, Health Economics Outcomes Research, Business Development & Licensing, market analytics, field sales organization, ... customer interactions, market research, competitive intelligence, demand, revenue forecasts, Business Development & Licensing activities, and agency partner… more
- Merck & Co. (Rahway, NJ)
- …discovery and development (MIDD) to routinely enable efficient drug discovery/ development and/or regulatory decisions. The Pharmacometrics group within QP2 ... our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented...ability to understand how (MIDD can drive portfolio and regulatory decisions Deep knowledge of drug development ,… 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
- Merck & Co. (Rahway, NJ)
- …regarding commercialization strategies, portfolio prioritization and sourcing, clinical development /research strategies, and Business Development ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... the strategy, prioritization and planning for IT systems and projects. Partner with business leaders, SMEs to understand how the functions operate today and what… more
- Merck & Co. (Rahway, NJ)
- …discovery and development (MIDD) to routinely enable efficient drug discovery/ development and/or regulatory decisions. The Pharmacometrics group within QP2 ... at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
