- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure delivery of RBQM CSM Training with Learning and Development team members. Lead development and implementation of process improvement initiatives ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across ... and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.The incumbent will bring a combination of technical expertise,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryReporting to the Senior Director, I&A, the Associate Director, Global Oncology Forecasting will drive ... The Associate Director is a dynamic member of the Global Oncology I&A Team and partners closely with Market Research, Competitive Intelligence, Marketing, MA, R&D,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and evaluate the best available or innovative technologies.Present recommendations to senior leadership and stakeholders to secure approval and funding for ... passion for digital transformation.Familiarity with digital tools such as data analytics platforms, workflow automation technologies, and change management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and ... risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders at all levels to articulate the value and progress of continuous improvement efforts. Team Leadership Lead , mentor, and develop a team of ... teams to embrace Lean, Six Sigma, and related methodologies. Partner with senior leadership to identify and prioritize improvement opportunities with the greatest… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of sponsored research agreements by partnering closely with the US legal team and the GBD Transactions team as required.Proactively search for, ... Partner with the other members of the Daiichi Sankyo Business Development team to assist with Development stage opportunities in cancer and specialty medicine.In… more
- Genmab (Plainsboro, NJ)
- … Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team .As Senior Clinical Drug Supply Manager you will play a pivotal role ... development of mitigation plans for operational challenges.Mentor and coach team members, fostering a collaborative and high-performing environment. Lead … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) department of ... leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships: Foster development of… 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 ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...ready to experiment with us? The Position The HCP Senior Strategist will be a pivotal driver in shaping… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technology solution providers. Relationships This position will report to the Senior Director, Procurement Operations, Digitalization and BI Lead , and ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implement successful product plan. Helps to shape strategy and culture within their team . Relationships Reports to Rare Bleeding TA Lead and is responsible ... that are consistent with the priorities of the business Recruit, build and lead a highly effective marketing team Physical Requirements Approximately 20-30%… 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 ... a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires...The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will interface with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and effective use of products by patients and the medical community Assures team determines appropriateness of data and references used to support promotional ... messages and providing proactive recommendations and/or guidance for alternative data /references/language where needed Assures team reviews, provides comments,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position As a senior member of the Advanced Analytics & Innovation Team (within Enterprise Data & Advanced Analytics), this role conceptualizes, defines, ... and programs for the NNI organization. Manages a small team of data scientists that work across...elsewhere internally or at vendors. Relationships Reports to the Senior Director, Advanced Analytics & Innovation. Works closely across… more
- Genmab (Plainsboro, NJ)
- …that they are implemented, if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information depending ... of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory...on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE team . This role will interact ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...(EGP). Externally, the Associate Director RP will be the lead for research within a specific therapeutic area (eg,… more
- Genmab (Plainsboro, NJ)
- …publications strategy and activities across the Hematology portfolio. The individual will lead the Hematology medical communications and publications team and ... of the Global Medical Affairs department, this individual will report to the Senior Director of Medical Communications and Publications.We have a hybrid model, and… more
