- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...by the RWE and modeling teams within CDSE. The Manager , HEOR Evidence Strategy and Synthesis is… more
- Merck & Co. (North Wales, PA)
- …Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Lot Distribution Data (LDD), etc.) and that is in alignment with the regulatory strategy . This individual works cross-functionally with internal and external ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...be responsible for managing projects, processes, or programs with manager oversight Knowledge of FDA and Health Canada eCTD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... at different levels are also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter expert in clinical data standards… 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 Our Commercial Strategy and Marketing group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving ... insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers....to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the… more
- Lundbeck (Murfreesboro, TN)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Aequor (Thousand Oaks, CA)
- …and Workforce Strategy program that currently consists of the E2E Regulatory Content Automation and Regulatory India initiatives. Additional initiatives may ... all initiatives Maintain single source of truth for status of all Regulatory roles being hired in India throughout recruitment, transition, and sustainment phases… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Lundbeck (Gary, IN)
- …and transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Lundbeck (Houston, TX)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... programmer.Drug Development Strategy : Provides input to multiple aspects of the development...phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO /… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... highest standards of performance, scalability, and reliability.- Drive the organization's GenAI strategy forward as a member of the GenAI Center of Excellence (CoE).… more
- Aequor (Thousand Oaks, CA)
- …resumes prior to call will be shortlisting EOD Wednesday 11/13 Operations Strategy & Business Resilience (OSBR) is a diverse internal management consulting arm ... lead to business disruption; Drug Substance (DS) and Drug Product (DP) Network Strategy , develops and progresses 's manufacturing network strategy to meet… more
- Genmab (Plainsboro, NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDT Provide scientific… more
- Eisai, Inc (Nutley, NJ)
- …& Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk assessments and guidance regarding Eisai's ... compliance with regulatory , organizational, and commercial requirements that govern the organization's technology systems and information assets.Purpose of… more
