- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8 years of relevant … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory … more
- 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... 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)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... 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
- Merck & Co. (Upper Gwynedd, PA)
- …well with other relevant internal stakeholders - early development teams, commercial, CORE, Scientific affairs , Market Access, among others - to develop and ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets...(advisory board meetings) in partnership with Executive Directors of Scientific Affairs to remain on the leading… more
- Merck & Co. (North Wales, PA)
- …five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Merck & Co. (North Wales, PA)
- …and maintain strong relationships with Scientific Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical ... Job DescriptionKey Responsibilities: Lead overall Scientific Strategy development and execution for Pneumococcal Vaccines FranchiseLead annual scientific … 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 ... staff in the creation of the development strategy ensuring the highest scientific /medical standards in accordance with ethical and regulatory requirements across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible for: Providing scientific and medical ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… 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 ... on scientific questions relevant to one's areas of responsibility.The Clinical Director is responsible for maintaining a strong scientific fund of knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical 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… more
