- 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 ... you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. ... with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... division and IT, including scientists, engineers, IT architects, infrastructure, quality , vendors in building, optimizing, and troubleshooting the OT automation… more
- Merck & Co. (Rahway, NJ)
- …(mAb), antibody-drug conjugates, and fusion proteins.Strong grasp of Critical Quality Attributes/QbD/DOE principles and statistical data analysis ... will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the… more
- Merck & Co. (Rahway, NJ)
- …transport, chemical/biochemical reaction kinetics, etc. applicable to biologics and vaccines), data driven models, and other modeling methods. Your experience should ... reduced costs, fewer experiments and batches, faster timelines, improved quality and process robustness.-Demonstrate creativity in solving complex, physical/biochemical… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Genmab (Plainsboro, NJ)
- …adhering to well-architected-frameworks and delivery standards for excellence in execution. You'll lead a skilled team, with the potential to expand, focusing on ... and document reference architecture for various R&D systems and functions.Provide data architecture skills to support core solution architecting and integration of… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... of small molecule, peptides and biologic modalitiesReview and approval of data and technical documents including critical evaluation of predictive modelsAbility to… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) ... mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line...small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) / Quality by Design… more
- Genmab (Plainsboro, NJ)
- …be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural ... to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply Team discussions.Change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....(EGP). Externally, the Associate Director RP will be the lead for research within a specific therapeutic area (eg,… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship.- As a key senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position Serve as lead for CRM (customer relationship management) system supporting NNI… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, this ... cross-functionally to ensure scalability.It is expected that you will take lead of strategic initiatives, mentor colleagues, and resolve complex operational… more
- Merck & Co. (Rahway, NJ)
- …development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays an… more
