- 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 ... subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a… more
- Merck & Co. (North Wales, PA)
- … senior leadership by providing overall operational support for research conducted in compliance with Good Pharmacoepidemiology Practice (GPP), Company Policies, ... and Skills:Required:Three or more years of work experience within clinical /observational research or equivalent-Excellent communication and interpersonal skills;… more
- Merck & Co. (North Wales, PA)
- …Standard Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport...global healthcare through research and innovation. Through clinical trials and… 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...a difference? The Position Leads the execution of observational research studies through the hands-on analysis of real world… more
- Merck & Co. (Rahway, NJ)
- …Degree in life sciences, preferred.Required experience and skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH).Ability to ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … 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 ... to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research , Biostatistics, Statistical programming, Clin Ops. etc. to… 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 ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …East, etc.- Strong analytical and problem-solving skills.- Some knowledge of pharmacology, clinical research , and medical terminology and use it for study ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary Position leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to 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)
- …of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...for NACD & Novo Nordisk (eg, Health Systems, Contract Research Organizations & Site Management Organizations etc.) Manages relationships… 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 ... business development goals through the successful negotiation and execution of research and strategic partnership contracting agreements. In collaboration with the… 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 ... and other strategic initiatives. This includes, but is not limited to: Research , Product Development, Clinical Development, Regulatory Affairs, CMC, New… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory ... Data Manager will be a key member of the Global...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position will ... 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)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization....a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Insmed Incorporated (Bridgewater, NJ)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Consumer Strategist Manager will be a critical driver in shaping an insights-driven Consumer marketing ... experience throughout the treatment lifecycle Target Segment Identification: Utilize market research and data analysis to identify and define specific patient… more
