- Aequor (Washington, DC)
- …regulations, guidelines and regulatory policies issues. Liaise closely with colleagues (R&D, External Affairs , etc.) leading policy activities in the external ... related to policy, product/project strategy, FDA engagement, and other external engagement efforts Ensure effective execution for new innovative consumer-centric… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) ... the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.Responsibilities- Responsible for the development of the Global Medical… more
- Eisai, Inc (Nutley, NJ)
- …and scientific content of Regulatory, Safety, Scientific Affairs , Medical Affairs and Commercial outputs for assigned therapeutic areas. External leadership: ... your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) ... 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)
- …The Therapy Area (TA) head is accountable for setting an integrated medical affairs strategy, scientific engagement plan and execution of that plan for the relevant ... in response to customer needs. Relationships The position reports into VP, Medical Affairs and will have all relevant in-house and field functions required to run… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Medical Affairs team advances medical science and patient care by engaging in scientific exchange with external medical experts and industry ... is developed and realized. Role Summary: The Executive Director, Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide… more
- Merck & Co. (North Wales, PA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops ... Reports, Protocols, Investigators' Brochures before release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR)… more
- Eisai, Inc (Nutley, NJ)
- …management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role will drive ... new approaches to identify and resolve complex and critical Medical Affairs challenges and opportunities. This individual will work collaboratively within Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select… 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 in ... and Catalent employee. The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing… 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
- Novo Nordisk Inc. (Chicago, IL)
- …business needs. Relationships This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA head). They will coordinate ... coordinate with key functions across CMR (eg NACO), Public and Government Affairs and commercial. Participate in direct customer engagement activites when needed.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThe Director, Global Oncology Medical Affairs , Evidence Generation role is responsible for co-leading a cross-functional ... 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)
- …diseases and immune disorders.SummaryThe Senior Director, Global Oncology Medical Affairs , Evidence Generation role is responsible for co-leading a cross-functional ... 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)
- …Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to...other local and headquarter departments to accomplish company goals. External relationships may include interaction with FDA personnel regarding… 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
- American Honda Motor Co Inc (Washington, DC)
- Job PurposeAbout this Position: Corporate Affairs is at the forefront of managing critical relationships with key stakeholders, including engagement with ... Honda's reputation. This role is responsible for managing the Regional Corporate Affairs Department. The position will lead a team of regional/local corporate … 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 ... utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities include: Support the implementation… 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)
- …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
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