- Insmed Incorporated (Columbus, OH)
- …to the highest standards The Therapeutic Specialist will possess a high clinical aptitude and seasoned experience in a portfolio environment to ensure the ... and Company goals, establishes open and honest communication with peers and senior leadership Contribute to the development and implementation of key sales enablers,… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands ... the territory for clinical research, finding and developing new-sites. Participates in internal...CRA team knowledge by acting as process Subject Matter Expert -(SME), sharing best practices, making recommendations for continuous improvement… more
- 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 interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of… more
- Lundbeck (Bothell, WA)
- …to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of ... and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough...for all development programs (from early to late phase clinical development) Author and review SOPs, development reports, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise.… more
- Merck & Co. (North Wales, PA)
- …talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and Clayton; provide feedback to case handlers Serve as Subject Matter Expert for adverse events and technical complaints during audits/inspections Assist with… more
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... (Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our… more
- Merck & Co. (Rahway, NJ)
- …strategies with corporate goals and providing critical therapeutic area insights.Recognized clinical research expert in areas such as atherosclerosis, ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and be at the forefront of developing and implementing policies, processes, ... with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and managed and that QCO… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials ... and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject… more
- Merck & Co. (Boston, MA)
- …community, research conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our company's powerful ... while advancing your career.Job Description:Our Company is currently seeking exceptional Senior Scientist peptide chemists to join our Boston site's highly… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes ... expert medical/scientific knowledge in assigned therapeutic area to provide...shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions… more
- Merck & Co. (Rahway, NJ)
- …Development Quality organization and for the company's R&D division.For company's Clinical Supply, act as the Quality Unit representative for information technology ... thereby promoting permanent inspection readiness.Develop and maintain a subject matter expert level of understanding for the company's Policies, Procedures and… more
- Lundbeck (Miami, FL)
- …airport. Territory consists of Florida, Georgia and Puerto Rico SUMMARY: The Senior MSL, Neurology will apply advanced field based medical and scientific experience, ... KOLs and external stakeholders internally to serve as advisors, investigators, expert consultants, authors, or evidence generation partners Executes on MSL goals… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... experience in dermatology to serve as the company's subject matter expert (SME) in companion animal dermatology, including:Traditional dermatology therapeutics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …profile. Provide a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety biomarkers ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
