- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... or initiates RBQM operating procedures and standards; monitors and enforces compliance of standard procedures and processes. Proactively manages resource planning to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director FP&A position is an integral part of the finance team supporting ... any variances and implications on business performance. Works with Director of FPA to streamline and improve reporting to...as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in ... collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection readiness of all data management activities ... conducted internally or outsourced Management of the function:Provides strong leadership and inspiration to the Data Management function. Hires, develops, and retains talents. Responsible for the performance management of the Data Management function,… more
- Merck & Co. (Rahway, NJ)
- …across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates ... in GAMP5, Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.Stay current with emerging technologies and industry trends;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... Director will lead franchise programs, and will be the...across teams, to accomplish critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The USMA Health Systems (HS) Director , Strategic Medical Implementation Lead, plays a critical leadership role in advancing the strategic ... across the Health Systems field medical enterprise.The USMA HS Director , Strategic Medical Implementation Lead, holds primary responsibility for integrating… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOverviewThe Associate Director of Federal Tax Audit plays a crucial role in supporting the audit function within the Tax Department, reporting ... directly to the Director of Tax Audits. This position is responsible for...and various internal teams at our Company to ensure compliance and effective audit execution.The Federal Tax Audit Associate… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate ... Director will work with scientists within QP2 by applying...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …increasing overall operational effectiveness.We are seeking a dynamic and experienced Associate Director of Outside Counsel and Vendor Management to join our Legal ... report directly to the Chief of Staff to the General Counsel & Executive Director , Legal Operations, Innovation & Technology and will be based in Rahway, NJ.- This… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and ... exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Sustainability Strategy & Engagement will join the Company as a member of the Social Impact and Sustainability (SIS) function, ... health, employee engagement, and ethics and values. The Associate Director will serve as a trusted advisor to business...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process needs… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures… more
