- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based in ... for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. The fellow will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings (development and ... Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel Ability to travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or ... Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities associated with the registration and support of new and approved drug products.Seeks and incorporate regional and functional RA strategy into a global ... required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability to interpret and understand US regulations governing… more
- FirstEnergy Corp (Jersey City, NJ)
- …Service Company, a subsidiary of FirstEnergy Corp. [SC00]The Regional External Affairs Consultant (REAC) is a remote position supporting Northern New Jersey. ... political and regulatory strategies in concert with the company's Rates, Governmental/Regulatory Affairs and Economic Development groups - Acting as a proactive and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or Senior Director of a drug development function such as Clinical Drug Development (preferred) or Medical Affairs . Experience managing teams and large-scale ... ensure M&S area is a strategic partner in the projects and clinical drug development activities. This includes actively driving innovation and taking a broader and… more
- Eisai, Inc (Boston, MA)
- …Medical Science Liaison (Sr.MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific ... between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups.Establish, foster, cultivate and maintain peer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… 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
- The George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: GW's Division for Student Affairs engages and supports student learning by creating and fostering communities that promote ... activities that promote connectedness, diversity, inclusion, and belonging. The Student Affairs team is comprehensive and collaborative and supports the mission to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the life-cycle ... Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well organized,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Stakeholders include many functions within R&D and Commercial, and Medical Affairs . Responsibilities will be both process/capability development for a relatively new ... management initiatives preferred- Prior experience in clinical development, Medical Affairs , or Global Marketing preferred- Demonstrated success in planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery of transitioning ... 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)
- …will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will ... research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key external experts,… more
- Merck & Co. (Rahway, NJ)
- …formulation development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development ... with formulators and device engineers to develop robust and innovative drug product manufacturing processes.- Close partnership with colleagues from Formulation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical Affairs , ... with 15+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal and written communication skills Strong organizational… more
- Fidelity TalentSource LLC (Boston, MA)
- …part of the Innovation and Change Communications team within Fidelity s Corporate Affairs organization. If you are looking to build a career journey in ... communications, Corporate Affairs is the place to be! Corporate ...or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances:… more
- Merck & Co. (North Wales, PA)
- …of generating early clinical development plan and Investigational New Drug applicationsDeveloping clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publicationParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response. The Mass Spectrometry group within the TMB ... collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials. Position… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
