- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Professional Services is a field-based position responsible for hiring, leading, coaching and motivating a team of ... the companion animal business through medical education and business acumen.The Associate Director partners with peer leaders to develop and execute a strategy for… more
- Merck & Co. (Rahway, NJ)
- …multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory, Legal etc. as well as external partners (diagnostic ... across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Medical Affairs (GMA) Oncology- Medical Content and ... responsible for execution of global scientific and training deliverables. The Associate Director develops and executes Medical Content and Training plans and works… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, and implementing Core… more
- Merck & Co. (Rahway, NJ)
- …as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as ... countries, clusters.-Responsible for collaboration with functional outsourcing vendors, investigators, other- external partners in assigned studies.-Country POC for programmatically outsourced… 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)
- …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
- 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
- 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)
- …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)
- …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
- 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)
- …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)
- …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
