- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the ... the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.Responsibilities-Responsible for the development of the Global Medical … 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 ... Gastroenterology. Required experience and skills: A minimum of 5 years regional medical affairs experience (eg, Regional Director Medical Affairs ) with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the ... the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.Responsibilities- Responsible for the development of the Global Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... The Position Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs , Evidence Generation role is ... Outcomes Research partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs ...plans for delayed activities. Ensure that appropriate internal and external communication is current and clear.- Drive the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs , Evidence Generation role is ... the Alliance Partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs ...plans for delayed activities. Ensure that appropriate internal and external communication is current and clear. Ensure communication of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease ... of review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the regional strategists in terms of HA meetings globally. Responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , GMA Oncology, Scientific Engagement is responsible for the execution of ... activities in support of Global Medical Affairs Scientific Engagement strategies and plan for the Solid Tumor or Hematology therapeutic area (TA), under the guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ... labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …internal cross-functional teams (eg, Diagnostic Development Teams) and to external diagnostic business partners specifically:Use of CTA/CDx within clinical ... trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEsBiomarker strategies towards patient selection,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in ... of the Novo Nordisk portfolio. Relationships This position reports directly to the Executive Director , Medical Affairs and will assist the Executive Director … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction ... of the Senior Director , GMA Oncology ADC (Global Medical Affairs ...medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary: The Oncology Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who ... of Interest (AOI)Research: Upon request from Global Center for Scientific Affairs (GCSA),Initiates discussions with SLs and/or potential investigators that include… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Global Marketing will join the New Assets Brand Strategy team and help build the future of our Company's Oncology. This role ... execution and budgeting. Launch Excellence & Governance: Support Global Marketing Director and the cross functional launch readiness team, including agenda, team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and approach to engage ... the regional reps to build and leverage a network of relationships with external stakeholders and regulatory authorities to ensure DS' perspective is reflected in… more
- Merck & Co. (Rahway, NJ)
- …expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC professionals and ... solid-oral small molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the Global Regulatory Affairs … more
- Novo Nordisk Inc. (Chicago, IL)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/ external SOPs/rules and… more
