- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and ... input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good ... clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities:Lifecycle Management: Oversee and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Merck & Co. (North Wales, PA)
- … Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology ... about twenty (20) percent of the time to manage future or ongoing clinical research projects.-EducationM.D or MD/Ph.D.Board certified or board eligible in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics, ... eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… more
- Merck & Co. (Rahway, NJ)
- … regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... and biologic veterinary compounds by following good Data Management practicesTo collaborate with Clinical Research Assistant (CRA) on Case Report Forms / Data… more
- Merck & Co. (North Wales, PA)
- Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …and vaccines for the benefit of patients and global human health. The Associate Principal Scientist, Clinical Trial Analysis and Reporting leads the statistical ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company.- Position Description/Summary: The GPAM … more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary: This position ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research , ... global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs,… more
- Merck & Co. (Lower Gwynedd, PA)
- …developing and expanding your career.We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, ... successful candidate will be to design and develop immunology-based preclinical and clinical assays for our vaccines pipeline. The individual will be responsible to… more
