- Merck & Co. (Rahway, NJ)
- … supports the implementation and maintenance of the Program.- The Associate Director has experience with pharmaceutical industry compliance programs, is ... Status:- Regular Full TimeA part of the Ethics and Compliance Organization (ECO), the Compliance Program Oversight team (the "Team") designs and helps implement… more
- Merck & Co. (Rahway, NJ)
- …to help drive our privacy strategy, implement our global privacy program, ensure compliance with global data protection laws, enable innovation in an evolving and ... other team drives program governance and privacy operations, supporting privacy compliance through the development and maintenance of program strategy, processes,… 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)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... Data Validation and Reporting resources, CROs, and vendors to ensure compliance with the programming standards and practices, SOPs, external/internal data standards,… 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)
- …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)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... oversight for Data Management resources, CROs, and vendors to ensure compliance with the program standards, Policies, SOPs, external/internal standards, Good… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and service management principles for HRIT support, data security and compliance as well as functional and solution knowledge pertaining to Performance, ... Compensation, Variable Pay and proficiency in relevant software and tools are essential.Business Expertise: Good understanding of industry and comprehensive knowledge of HR functional areas and processes and understanding how they interact and contribute to… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …databases of claims and electronic health records data, vendors, and ensuring compliance to contractual terms and data security requirements.- Develop, review, and ... contribute toward the approval of the US HEOR RWE study or model description, supporting and completing the relevant initiatives to fulfill the strategy, including finalizing published materials such as manuscripts, abstracts, posters, and slides. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... informed about new developments, leverage opportunities, and share best practices. Compliance responsibilitiesEnsure that all activities of the CoE group comply with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …materials are global, region and/or local approved by legal and compliance authorities based on the location of the congress.- Relationship ManagementCo-lead ... association relationship with Global Medical Affairs- Support all Programs Grants Committee (PGC) sponsorship submission approvals.- Oversee charitable contribution approvals in partnership with global advocacy as it relates to global oncology congresses.-Full… more
- Merck & Co. (Rahway, NJ)
- …drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …motivated and experienced Anatomic Pathologist (MD) for the role of Principal Scientist ( Director ) to join our innovative team. This position will play a crucial ... pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the following responsibilities: Engage in providing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... mitigate risks, and continuously enhance performance. Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.… 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
