- Merck & Co. (Rahway, NJ)
- …field CVM team that are aligned with GMSA medical strategies.Co-chairs Regional Medical Affairs Team (RMAT) meeting with US Regional Director Medical Affairs ... Job DescriptionThe Executive Director for Cardiovascular & Metabolism (ED CVM) within US Medical Affairs (USMA) will lead the USMA field medical (FM) teams… 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)
- …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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position pro-actively reviews and interprets regulatory ... to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA Project Managers… 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
- 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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other departments including ... Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and maintains constructive and positive interactions… 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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... Affairs and Commercial outputs for assigned therapeutic areas. 20% External leadership: Provides leadership and strategic direction to stakeholders in… more
