- Merck & Co. (Rahway, NJ)
- …review and final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and ... with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's… more
- Merck & Co. (Rahway, NJ)
- …the world.Looking for someone with a growth mindset.Position Description: The Senior Director, Global Regulatory Lead , is responsible for development and ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce accurate ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix environment in the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality, and Commercial-facing ... join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in overseeing and guiding analytical… more
- Merck & Co. (Rahway, NJ)
- …and melanoma oncology program; heavy emphasis on milestone communications ( regulatory approvals, data releases, medical meeting communications).Drive global ... Job DescriptionThe role of Director, Global Communications, Oncology is a unique opportunity to...but will not be limited to the following key activities: Lead communications activities in support of our company's lung,… more
- Merck & Co. (Rahway, NJ)
- …database standards, SOPs, and Process Guidelines. You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and ... new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, and… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... EIT SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
