- Merck & Co. (Upper Gwynedd, PA)
- …risk mitigation measures.-Lead development and execution of global product and project regulatory strategy (ies) by ensuring robust assessment of global ... risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in portfolio strategy , strategic planning or related roles within the pharmaceutical industry or a related industry required Strong knowledge of the ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy , regulatory compliance framework, and overall quality assurance standards. ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Merck & Co. (Rahway, NJ)
- …and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy ... working closely with the group Director to define group strategy and to lead a team of scientists in...a minimum of 8 years of experience in the pharmaceutical industry, MS in analytical chemistry/biochemistry or related field… more
- Merck & Co. (Boston, MA)
- …Collaboration, Modeling Software, Multidisciplinary Collaboration, NONMEM, Pharmaceutical Development, Pharmaceutical Sciences, Pharmacodynamics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... and immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a marketing role within the pharmaceutical industry Experience in pharmaceutical industry/life science brand marketing strategy and planning; experience ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Lundbeck (Edmond, OK)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by overseeing 5D efforts including Data, Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, aligned closely with Rare Disease ... development of the go-to-market plan for the launch of a customer-centric strategy and initiatives that will enable awareness, early diagnosis, differentiation and… more
- Eisai, Inc (Nutley, NJ)
- …relations, government price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and ... of assigned business clients.Helps drive the implementation of legal strategy and policies.Develops training content as needed on legal...standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …Immunochemistry, Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory ... Job DescriptionDirector, Oral Formulation Sciences Job Description:Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules… more
- Merck & Co. (Rahway, NJ)
- …to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal role ... accredited college/universityRequired Experience and Skills:Relevant work experience in chemical, pharmaceutical , large molecule, or vaccine process development, including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …field engagement role within the pharmaceutical industry Experience in pharmaceutical industry/life science brand marketing strategy and planning; experience ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
