- 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
- Merck & Co. (Rahway, NJ)
- …labeling and obtain shortest time to approval by regulatory agencies.Functions as global regulatory lead assigned to programs where the compound is ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory...of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… 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 ... and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across… 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)
- …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 SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… 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 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)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical Trials ... and project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is-required.-Strong Communication skills requiring… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… 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. Job Summary: The Director of Data Management (DM) Reporting provides leadership in...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader , a Senior Principal Scientist/Senior Director , has primary responsibility for developing value ... and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck & Co. (Rahway, NJ)
- …initiatives designed to promote a culture of integrity across our global operations.Key Responsibilities:Conflict of Interest Program Management: Lead the ongoing ... Job DescriptionSummary of PositionThe Global Ethics team actively supports our Company's commitment...Team is seeking a dedicated and experienced individual to lead the Conflict of Interest (COI) program, dedicating 50%… 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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... 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
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
