- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including… more
- Merck & Co. (Rahway, NJ)
- …of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to ... inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Merck & Co. (Rahway, NJ)
- …Bachelor's degree + 5 years OR Master's + 3 years Pharmaceutical and/or clinical drug development experience OR PhD/PharmD Degree in life sciences, ... the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position,...team lead- May lead team in key study planning, development , and execution elements (eg, data management deliverables, trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The Senior Manager reports directly to a Senior Director within the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Merck & Co. (North Wales, PA)
- …primary data collection, chart review/survey, database studies, health economic model development and adaptations, dossiers, other activities in support of HTA, and ... Outcomes Research, V&I GMSA, BARDS HEDS, and others as determined by senior leadership by providing overall operational support for research conducted in compliance… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical support for low to medium complexity studies including contributing to development of optimal study design, follow and execute statistical analysis plan ... results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to Health… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development .The primary role of the Senior ... strategic initiatives. This includes, but is not limited to: Research, Product Development , Clinical Development , Regulatory Affairs, CMC, New Products,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical … 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 ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will be responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning ... organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... driving strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …with field sales forces are accomplished. Essential Functions Regional account manager (ram) coaching: Ensure that RAMs understand their level of accountability ... for assessing customer needs. Ensure customer objectives integrate into program development (contracting, marketing programs) Create advocacy for NNI & Diabetes… more
