- 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)
- …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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in ... alignment and collaboration with all stakeholders. Under the direction of the Director , Strategic Scientific Content Development, Global Medical Affairs , this… more
- Eisai, Inc (Nutley, NJ)
- …#IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Director , Real World Evidence, Global Medical Affairs is from ... difference. If this is your profile, we want to hear from you. The Director is responsible for developing RWE strategies for assigned product(s) and execution of RWE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... visible expert leader, he/she will engage the clinical, Medical Affairs and commercial organization and drive the product evidence...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… 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
- Insmed Incorporated (Bridgewater, NJ)
- …search of a passionate leader for the role of Biostatistical Head of Medical Affairs . This position, reporting to the VP of Biometrics presents a unique opportunity ... lead a team of statisticians to collaborate closely with the Medical Affairs organization to support evidence generation and publication strategy for all… 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)
- …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)
- …drug development process-Ensure GCO diversity related roles and responsibilities within external partners (eg CROs, specialty Vendors) are well defined, clear and ... internal groups (eg patient advocacy, ID Office, field medical, regulatory affairs , etc.)-Establish and oversee indication or study specific demographic targets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.- Participates in meetings with Health Authorities. Prepares internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.Responsibilities- Clinical Monitoring Planning : ... critically assess study conclusions and new study designs for early stage.- External collaboration: Ensure continuous, effective alignment within / between CRO and… 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)
- …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)
- …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)
- …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)
- …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
