- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... every patient, consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support regulatory strategy for product… more
- Merck & Co. (Rahway, NJ)
- …our products is developed and realized. Role Summary: The Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange ... Job DescriptionOur Medical Affairs team advances medical science and patient care...and patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team...to medical information, internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for… 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
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... and scientific content of Regulatory, Safety, Scientific Affairs , Medical Affairs and Commercial outputs for assigned therapeutic areas. External leadership:… more
- Merck & Co. (Rahway, NJ)
- …a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within ... closely with Subject Matter Experts, stakeholders, Learning & Development, external vendors, and IT support teams.Participate in SRO leadership activities,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Digital Innovation and Omnichannel Engagement will be responsible for the direction and ... management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role will drive… 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
- 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
- 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
- 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)
- …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
- Aequor (Newbury Park, CA)
- …Data Quality and someone who is able to communicate clearly with internal and external teams. Once training is completed, this individual must then understand how to ... issues within the scope of assigned products/franchises at the discretion of Director . Leads cross-functional teams in the development and maintenance of TPLs,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …the organization. Medical Affairs Functional Strategy: Partner with Medical Affairs Director of Strategic Optimization on overarching medical affairs ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Medical Process Excellence will be responsible to develop and evolve… more
- Merck & Co. (Los Angeles, CA)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ... in the greater Los Angeles Metro area. Role SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease… more
