- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is responsible for leading the dossier planning ... major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions...in all regions. The Director of Dossier Planning will report to Head of Global Regulatory… more
- Merck & Co. (Rockville, MD)
- …to support the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy, will include:Proactively monitoring emerging ... company responses to draft legislation, regulations, guidance, and other regulatory policy documents. Planning and managing interactions and communications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies adhere to ... external direct/indirect reports. This position pro-actively reviews and interprets regulatory guidelines with respect to impact development programs. Additionally,… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …the company as needed (including Senior Executives) and working closely with Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global ... Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and… 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
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... the identification and prioritization of intelligence efforts critical to strategic planning and execution for key stakeholders and will provide direction for… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements. Typically has administrative responsibility for recruiting,...support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... The CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset Leads. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to join a dynamic area of the business supporting the Disease Area Strategies ... for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing - Melanoma provides the opportunity to lead our… more
- Merck & Co. (Rahway, NJ)
- …on alliance global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by ... Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing team focusing on co-commercialization of an Antibody Drug Conjugate a… 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
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning , implementation and ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning … more
- Creative Financial Staffing (Columbus, OH)
- …posting journal entries. Coordinate with the Chief Administrative Officer and Executive Director for annual budgeting, planning process, and overall timelines ... reporting systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing regarding… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Merck & Co. (Rahway, NJ)
- …Order to Cash, Source to Settle, Supply Chain Management, Tax, and Financial Planning and Analysis, as well as Data standards governance, Analytics governance, and ... They have accountability for SAP integrated delivery of Source to Settle, Financial Planning & Analysis, and Tx. Their expertise in SAP and business process… more
