- Genmab (Plainsboro, NJ)
- …can work remotely 40% of the time. You will report to the Global Regulatory Strategy Team Lead .ResponsibilitiesThe responsibilities of the role will include, ... lead FDA meetings as relevant. Support global regulatory lead and labeling strategy ...effective, and compliant submissions in line with the overall strategy Drive compliance with regulatory … more
- Genmab (Plainsboro, NJ)
- …onsite presence 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory...working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The role of Channel Strategy Owner, Search reports directly into the Channel Strategy Lead , Paid & Earned. This role may regularly interface with their ... into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with customers… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare ... About the Department The Strategy & Rare Disease (STARS) organization drives the...commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Channel Strategy Owner, Customer Portal reports directly into the Channel Strategy Lead , Owned. This role will regularly interface with their direct ... Therapeutic Area leads, Sales, Patient Support Program, CIA&A, Medical, Legal, and Regulatory and IT. Essential Functions Portal Strategy Development: Leading… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Associate Director, Digital Strategy - Medical/Access/PSS & Paid Media will serve as the lead ... in the US. This critical role reports directly to the Senior Director of Digital Strategy and will be expected to work across assigned customers within our US lines… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe Associate Technical Lead will be part of Technical Operations and will...controls and maintain permanent inspection readiness and actively support regulatory inspections. This individual will also support the implementation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Technically independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the ... work, general instructions on new assignments. Knowledge of Automation GMPs, Compliance , and Regulatory requirements is essential Excellent communication skills… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …agent risk assessment and cleaning efficacy studiesStrong understanding of regulatory and compliance requirementsExcellent oral and written communication ... of multiple myeloma.Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based...will establish and maintain the cleaning validation program / strategy for the site. The role is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Medical Affairs, Market Access and Public Affairs (MAPA), Portfolio Strategy , Commercial Excellence, Regulatory Affairs, and other relevant NNI ... and segments Oversee tactical plans to support the engagement strategy 5D Lead innovation efforts to support...brand performance and patient outcomes Product Evolution Oversee product strategy and regulatory activities related to new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Merck & Co. (South San Francisco, CA)
- …in translational cell models, mechanistic pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The ... experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate will work closely with a team of… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a consistent brand/therapeutic area vision and message. Relationship Reports to Brand Lead or HCP/KOL Strategy Lead . Collaborates with cross-functional ... sales forecasts HCP/KOL Strategy : Supports the Brand Lead and HCP/KOL Strategy Lead ...especially within specified therapy area preferred Strong understanding of regulatory , compliance , and ethical considerations in engaging… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …area vision and messaging across all touchpoints. Essential Functions Consumer Support: Lead the strategy and development of consumer support offering in ... About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving… more
- Merck & Co. (Rahway, NJ)
- …of the following: process performance qualification, risk assessment, control strategy , process comparability reports, and/or regulatory submissions.Adaptability ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts… more
