- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products… more
- Eisai, Inc (Nutley, NJ)
- …EMRs, patient charts, administrative claims datasets.Previous RWE experience in clinical /medical development, and interactions with regulatory authorities is ... #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Director , Real World Evidence, Global Medical Affairs is from… more
- Eisai, Inc (Nutley, NJ)
- …patient charts, administrative claims datasets.Previous RWE experience in medical or clinical development, and interactions with regulatory authorities is ... Associate Director , Global RWE (Real World Evidence), Global Medical Affairs - Neurology is from :181,000-237,600Under current guidelines, this position is… more
- Genmab (Princeton, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible ... PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory… more
- Genmab (Princeton, NJ)
- …diverse antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the ... operations departments to coordinate the planning, execution, and management of clinical trial activities across medical affairs functions Contribute to… more
- Genmab (Far Hills, NJ)
- …our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US Medical ... solid tumor therapies and relevant studies Provides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Tris Pharma (Monmouth Junction, NJ)
- … clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development....Assurance (QA), Pharmacovigilance, Medical Affairs , etc.) on strategic and tactical clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery of ... managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by related internal groups (eg patient advocacy, ID Office, field medical, regulatory affairs , etc.)-Establish and oversee indication or study specific ... and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... Senior Director of Translational Medicine and Clinical ...key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work closely with cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a... development and regulatory requirements of a clinical program. The Director will provide high… more
- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support...Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
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