- Novo Nordisk Inc. (Plainsboro, NJ)
- …support in other aspects of company activities in the assigned therapeutic area . Relationships Reports to the Executive Director - Clinical Research & ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...guidelines, current trends and medical practice in the assigned therapeutic area , including reports and intelligence on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …roles. Essential Functions Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA : Compile, submit and maintain applications (IND, NDA, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area .Ensure operational aspects are incorporated into CDP planning and individual ... plans.CRO and Quality OversightResponsible for oversight of all CROs utilized within their therapeutic area . May represent Clinical Operations on the DS/CRO… more
- Eisai, Inc (NJ)
- … trial programs within the Medical Affairs department for products in the therapeutic area . The Medical Director utilizes expert medical/scientific knowledge ... medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area . This role is responsible for working with key… more
- Eisai, Inc (Nutley, NJ)
- … trial programs within the Medical Affairs department for products in the therapeutic area . The Medical Director will utilize expert medical/scientific ... area . Under the direction of the Senior Medical Director , this role will be responsible for working with...of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to Sr. ManagementAdditional non-study related activities: Provides input on KEE selection for Therapeutic Area ; Reviews content to be shared with KEEs; Frequent ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Eisai, Inc (Nutley, NJ)
- …medical input into the lifecycle management strategies for that therapeutic area .She/He will strategize and execute Phase IV clinical development programs ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area .Knowledge… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Merck & Co. (North Wales, PA)
- …of the scientific and medical rationale for assigned therapeutic area (s) and the ability to learn the clinical development strategyThorough ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source...agencies.- By providing global publication insight, knowledge of the therapeutic area , and scientific expertise, they will… more
- Novo Nordisk Inc. (Chicago, IL)
- …trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...in respective area may be required for Therapeutic Area Previous experience working in a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial ... to develop and apply QSP models to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial… more
- Merck & Co. (North Wales, PA)
- …regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area .The selected individual will function with a high degree ... Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development...regulatory advice and approval according to the committee charters ( therapeutic area Document Review Committees, Product Development… more
- Merck & Co. (North Wales, PA)
- …Affairs teams guide the medical affairs organization's strategy within the therapeutic area . The MCRP also leverages clinical practice and therapeutic ... GMA global assurance process for country assessment.US and Global Medical Information-Leverage clinical practice & therapeutic area /product expertise to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required rExperience Qualifications10 or More Years overall ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical ... equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required Experience Qualifications -10 or More Years… more
- Merck & Co. (Rahway, NJ)
- …strategy within pharmacology, vaccines, and biologics in conjunction with functional area and clinical development leadership. Contribute to the business ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and...and our companion diagnostic needs in oncology and other therapeutic areas. Key Responsibilities Include: Identify, evaluate, and execute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical ... equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required Experience Qualifications- 10 or More Years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Engagement strategies and plan for the Solid Tumor or Hematology therapeutic area (TA), under the guidance of the Director , GMA Oncology Scientific ... relates to Global Medical Affairs Scientific Engagement activities across the Oncology therapeutic area . Ensure all strategies, tactics, and activities are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Job SummaryTo succeed as global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller ... numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in...led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi… more
