- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations ... stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Merck & Co. (Rahway, NJ)
- … Data Product Management role, you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving ... team of highly talented individuals working on multiple data products and use cases, providing thought leadership and...to drive results and enable their success.Specific responsibilities include: Lead team to manage life cycle of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team (s) in support ... clinical studies in partnership with Clinical Safety Scientist Product Lead , PSL, Clinical Safety Physician(s), and cross-functional team (s).Collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team (s) in support ... Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team...and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team (s) in support ... Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team...and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure delivery of RBQM CSM Training with Learning and Development team members. Lead development and implementation of process improvement initiatives ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the ... (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. ... Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across ... and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.The incumbent will bring a combination of technical expertise,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunity assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of ... around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... through commercialization).ResponsibilitiesDepending on the status of development of the compound, lead and medical-scientifically direct a team of junior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate ... Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for...For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders at all levels to articulate the value and progress of continuous improvement efforts. Team Leadership Lead , mentor, and develop a team of ... 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)
- …a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of sponsored research agreements by partnering closely with the US legal team and the GBD Transactions team as required.Proactively search for, ... Partner with the other members of the Daiichi Sankyo Business Development team to assist with Development stage opportunities in cancer and specialty medicine.In… more
