- Merck & Co. (Rahway, NJ)
- …with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of ... Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine… more
- Merck & Co. (Rahway, NJ)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, ... This role has broad accountabilities for the following: - Regulatory Data Management ( RDM) Strategy &...with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices… more
- Merck & Co. (Rahway, NJ)
- …pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs.Participate in meetings with global regulatory agencies to provide CDx expertise.Provide CDx input ... Job DescriptionIn this Sr. Principal Scientist/ Director position within Translational Oncology, this team member...collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global … more
- Merck & Co. (Rahway, NJ)
- …modeling of tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global...methods. Experience in IND, NDA and other submissions to global regulatory agencies. Skills in experimental design,… more
- Merck & Co. (Rahway, NJ)
- …barriers to reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn ... the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …and adherence to our Policies, Rulebook Standards, and Specifications.Monitor the evolving global regulatory landscape, including tracking and analyzing new data ... seeking a skilled privacy professional to help drive our privacy strategy , implement our global privacy program, ensure compliance with global data… more
- Merck & Co. (Rahway, NJ)
- …optimizing model-based analyses on programs. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ... and verbal communication. Experience in IND, NDA and other submissions to global regulatory agencies. An exemplary record of increasing responsibility,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescription The Associate Director position's core responsibilities are to oversee our Company's compliance related to customs country of origin. In ... company's customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily responsible for determining trade compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug regulatory procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development ... around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of...strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input… 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety ... for cardiovascular diseases, 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)
- …approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy , regulatory compliance framework, ... for cardiovascular diseases, 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets...RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy for Clinical Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead ... for cardiovascular diseases, 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU)...preparedness for the respective MA inspections in alignment with regulatory and company strategy . Act as management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... 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)
- …are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
