- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program ... experience for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... or Senior Director of a drug development function such as Clinical Drug Development (preferred) or Medical Affairs . Experience managing teams and large-scale… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... Corporate Business Management)Partner and collaborate with global marketing, global medical affairs , global payers and access and commercial business units to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/ drug forecasting to safety and regulatory requirements related to ... will lead the execution and lifecycle management of Global Medical Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Merck & Co. (Rahway, NJ)
- …Close partnership with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs , Engineering, and Analytical will be required to ... formulation development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development… more
- Merck & Co. (Rahway, NJ)
- …sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs , Procurement, and suppliers. Key Functions Work ... global and site-specific projects, including those related to Combination Products and Drug Delivery Systems.- The role includes leading, enabling or consulting in… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... with 15+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal and written communication skills Strong organizational… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Eisai, Inc (Indianapolis, IN)
- …Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data ... information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups. Establish, foster, cultivate and maintain peer… more
- Merck & Co. (Rahway, NJ)
- …and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical ... assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response. The Mass Spectrometry group within the TMB… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be… more
- Merck & Co. (Rahway, NJ)
- …may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the position may be responsible… more
- Merck & Co. (North Wales, PA)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Evaluating pre-clinical and translational work for… more
