- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a hybrid ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety… more
- Merck & Co. (North Wales, PA)
- …of statisticians and the statistical programmers to ensure that all programs meet analysis requirements, internal standard operating procedures, and external ... regulatory requirements.Represent statistics in meetings with management in strategic planning of projects.Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position will define and oversee the translational strategy/plan for oncology therapeutic program /s in global R&D. The successful candidate will set goals and ... Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program . Other responsibilities will include, but not be limited to, identifying… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes, and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global ... regulatory precedence and competitive landscape with respect to impact on development programs . Ability to serve and participate on internal and external panels… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not… more
- Eisai, Inc (Nutley, NJ)
- …develop and execute impactful pharmacometrics strategies in support of key decisions for programs across all phases of drug development. The complexity and scale of ... data being generated has grown significantly and requires strong scientific contributions to integrate different approaches in modeling, statistics, and data science to bring value to the Eisai portfolio. This role requires diverse modeling experience in drug… more
- Merck & Co. (Rahway, NJ)
- …time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior Director in the General Medicine ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder the guidance of a Senior Director , Outcomes Research (OR), the incumbent will have the primary responsibilities for developing the ... for planning and implementing Outcomes Research and Real-World evidence programs to meet the value evidence needs of payers,...ensure that product value is defined and developed. The Director will also work closely with Product Development Teams,… more
- Tris Pharma (Monmouth Junction, NJ)
- …ADHD portfolio and product launch. We have a position available for a Senior Director / Director , National Sales (NSD) to lead approximately 100-person ... managers to effectively deliver information on our products to Healthcare Professionals.The Senior Director / Director , National Sales (Sr NSD) provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...development of safety strategy and safety deliverables for assigned programs within the US East Coast Development Hub portfolio… more
- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... target market(s)Ensures all promotional materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior Medical Director in… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development and staffing of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management and/or strategic sourcing roles within the department. Relationships Reports to a Senior Director within the NNI Procurement Team and will interact ... and helps others do the same Supports the NNI DSI Supplier Diversity program and promotes the inclusion of diverse suppliers in all sourcing initiatives Manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, US East Coast ... innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for… more
- Merck & Co. (North Wales, PA)
- …have managerial responsibilities of ADT Leaders or Team Members that could include Executive Director , Senior Director , or Director level personnel ... in running multiple studies and protocolsKnowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the… more
