- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), ... clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Director, Clinical Safety , will be a product safety lead or part of a product safety team, and be responsible ... product safety strategy or specific areas of safety surveillance and risk management, and provide safety...Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, conduct ... of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety -related meetings… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... and Business support at the Millsboro site. The Site Digital Technology Lead ensures all project and commercial manufacturing activities are supported and delivered… more
- Merck & Co. (Durham, NC)
- …of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Catalent (Manassas, VA)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. As...Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Merck & Co. (North Wales, PA)
- …of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations. Lead and actively contribute to departmental strategic ... stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.Primary Activities :Address… more
- Aequor (South San Francisco, CA)
- …The group provides fit-for-purpose wet lab-based investigation to address target safety assessment, lead optimization, and issue mitigation by employing ... position is in the Investigative Toxicology Group within the department of Safety Assessment in Genentech's Research and Early Development organization. The mission… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early as ... possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure...the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead… more
- Merck & Co. (Boston, MA)
- …notebook entries.Participate in partner site visits to evaluate processes, capabilities, safety procedures and compliance standards as well as build workflows to ... data QC, protocol design, laboratory processes and best-practices, as well as safety standards.A minimum of 3 years in managing CRO relationships or equivalent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...testing. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Maintain detailed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead and/manage RMP initiatives and activities related ... to risk management planning, risk management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office to ensure risk management activities allow for effective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset Leads who… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and will be responsible to ... a culture of innovation across the whole organization, encouraging psychological safety and agile methodology to boost creative thinking and continuous improvement-… more
- Eisai, Inc (Nutley, NJ)
- …SMEs to understand how the functions operate today and what challenges are faced. Lead the analysis of the current state of business processes and systems. Establish ... define an overall vision, strategy and priorities to address unmet business needs. Lead the definition of future state IT Roadmap by establishing strong business… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for ... products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not limited to:Reports to Executive… more
