- 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
- 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)
- …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
- 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)
- …managementExhibit servant leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...as the best trusted quality partner with internal and external stakeholders. The incumbent must aim to instill a… 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)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of ... the Senior Director , GMA Oncology (Global Medical Affairs team...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)
- …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)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and execute ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… 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)
- …Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and Operational… 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)
- …to ensure successful implementation of CDx and data collection- Supports 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... framework. Leads briefings and technical meetings for internal and external representatives. Essential Functions Coordination/Communication and Administration: Work with… 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)
- …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)
- …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
- 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
- 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
