- Novo Nordisk Inc. (Plainsboro, NJ)
- …o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to encompass ... is to facilitate the development and to coordinate the execution of the long-term strategy, defining a sustainable business...on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic… more
- Merck & Co. (Rahway, NJ)
- …measures specified in local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance and standards team, which manages ... This role has broad accountabilities for the following: - Regulatory Data Management ( RDM) Strategy &...Activities include but are not limited to: - - Data Centric Submissions: Lead the data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... area, specifically the upcoming Icodec launch to guide the strategic planning and execution of the launch to ensure market readiness and optimize commercial success… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... areas, specifically the upcoming launches to guide the strategic planning and execution of the launch to ensure market readiness and optimize commercial success… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... in shaping an insights-driven Consumer marketing strategy, advising omnichannel execution , and measuring marketing effectiveness for our Alzheimer's Disease asset.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... process for Novo Nordisk's top PBM/payer accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes pre-deal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data ... as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance, handling and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory requirements is ... and clinical trial quality and risk management reporting requirements. Oversees the execution of external data -- acceptance, storage, and delivery activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug ... and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review… more
- Merck & Co. (Rahway, NJ)
- …Implement and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a ... shake flasks, and/or 2-3L bioreactor systems.Expertise in upstream lab scale experimental execution , Design of Experiments (DOE), statistical data analysis and… more
- Merck & Co. (Rahway, NJ)
- …world class outcomes in the following areas:Responsible for on-time, end-to end execution of DCT deliverables including - robust processes & analytics, an integrated ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (Rahway, NJ)
- …works under direction of the VCM Product Leader supporting the development and execution of end-to-end (E2E) product supply strategies for one or more Biologics ... continuity of supply, and commercial outcomes.The VCM Product Manager will help lead the cross-functional Supply Chain Working Group (SCWG) for pipeline products or… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including ... other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... as required, proactively identifying risks and supporting all phases of execution . Conduct technical due diligence assessments and provide expert consultation on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent ... Clinical Development, an organization dedicated to the effective strategy, design, execution , and interpretation of Oncology clinical trials. Position Summary /… more
