- Endo International (Woodcliff Lake, NJ)
- …everyone we serve live their best life. **Job Description Summary** The Associate Director , Commercial Counsel provides timely legal counsel on commercial ... the Company in managing risk with respect to regulatory compliance of commercial initiatives and promotional labeling through the...and guidance in fast paced fluctuating environment. + Good research skills with an ability to analyze and interpret… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Laboratory Data Management is accountable for the end-to-end ... oversight for Data Management resources, CROs, and vendors to ensure compliance with the program standards, Policies, SOPs, external/internal standards, Good… more
- IQVIA (Parsippany, NJ)
- *Home-based position Our Associate Directors in Clinical Project Management manage and support the operational elements and execution of studies and/or programs to ... of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures + Serve as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …- must be able to work with a variety of stakeholders at all levels within Research and Development and drive alignment to a common vision / goal + Expertise in ... functions involved in the various stages of drug development from early research through post-marketing + Strong experience in Good Clinical and Good… more
- Merck (Rahway, NJ)
- …managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio of clinical trials. GCS is accountable for the ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- IQVIA (New Providence, NJ)
- …activities related to employment legislation, HR systems, practices, procedures and compliance . * Lead implementation of projects and process improvement activities ... change management efforts involving reorganizations, mergers/acquisitions and transfers to ensure compliance to local legislation. * Provide reports and analyses as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... approval for either the US or EU. + Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to...for the review of country labeling deviations. + Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures own work ... + BA/BS with 10+ years' relevant experience. + Significant regulatory, quality, compliance or related experience in the biopharma industry. + Proven track record… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. **Summary** Oversees typically ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. **Summary:** The purpose ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and… more