- 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)
- …state government affairs strategy and engagement. Contributes to internal and external advocacy and educational materials and provides support to leadership in ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… 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)
- …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)
- …solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… 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
- Eisai, Inc (Nutley, NJ)
- …a 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's public policy ... to ensure patient access. This role will influence the external policy landscape so that the value of Daiichi...patients who need them.Responsibilities- As part of the Government Affairs Public Policy team, track, review, and analyze proposed… 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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... with the internal clinical study physicians and physician scientists as well as external investigators is expectedThe CS Group Lead will also ensure the writing of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on expert knowledge of opportunities and challenges within the function, company and external healthcare and industry trends. The Director will be responsible ... other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and manage oversight. The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position ... statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections of key ... Develops biomarker strategy in collaboration with Translational Medicine, Collaborates with external KEEs to refine study plans; Prepares and participate in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Stakeholders include many functions within R&D and, Commercial and Medical Affairs . Responsibilities will be both process/capability development for a relatively new ... disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx ... while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape Qualifications:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for ... leading all planning activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Stakeholders include many functions within R&D and Commercial, and Medical Affairs . Responsibilities will be both process/capability development for a relatively new ... disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... independently manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs , HEOR and other stakeholders to ensure expectations are clearly… more
