- Howmet Aerospace (Dover, NJ)
- Howmet Engine Systems (HES) seeks a highly qualified Associate Quality Director . They will be sharing the responsibility for all aspects of Quality for ... and functioning system of checks and balances that facilitate operations. The Associate Quality Director will assist the Business Unit (BU) by interfacing… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology, Prostate Cancer** As a ... member of the US Medical Affairs Oncology team, the Associate Medical Director , Prostate Cancer will support...Cancer will support the development and execution of high quality US medical strategy for the tumor type(s) and… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Associate Director , Market Access Data Specialist** ** Associate Director ... , Market Access Data Specialist - Commercial Data Solutions** The Associate Director , Market Access Data Specialist is a member of Bayer's growing Commercial… more
- IQVIA (Parsippany, NJ)
- ** Associate Director , IQVIA Participant Payments (ADIPP)** The Associate Director , IQVIA Participant Payments (ADIPP) is responsible for directing a ... based on their experience and training. + Manage the quality of assigned staff's work through regular review and...process. + Ensure that staff is meeting defined workload, quality and budget metrics through regular review and reporting… more
- Elevance Health (Morristown, NJ)
- **Clinical Ops Associate Medical Director ** **Orthopedic Surgery** **Location:** This is a virtual position. Candidates must reside within 50 miles of an ... insightful analytics to improve the delivery of care. The **Clinical Ops Associate Medical Director - Ortho** is responsible for performing pre-authorizations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical ... compliance standards, manage relationships, and oversee delivery to time, cost, and quality . This position is capable of leadership and oversight of vendor segments,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Consumer Marketing - US Rare Hematology **Location** : Cambridge, MA **_About the Job_** This role will drive consumer ... is based in Cambridge, MA and will report into Director of Consumer marketing for rare hematology. We are...a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents ... BA/BS with 10+ years' relevant experience. + Significant medical writing, regulatory, quality , clinical R&D, or related experience in the biopharma industry. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Statistical Programming manages the statistical programming group within the therapeutic area(s). The incumbent oversees all activities, ... team and external functional service providers to ensures timely and high- quality programming deliverables in assigned projects and areas. Manage the implementation… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and interpersonal… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …documents and evidence + Support with implementing and ensuring global DBMA quality standards for Change requests **IT Vendor Oversight and Management** + Managing ... and internal operations, while ensuring the highest level of quality + Collaborate with internal stakeholders - including IT...all data requests, perform self-QC of data to ensure quality of results. **Service Provider Oversight & Management** +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …This individual is responsible for data management activities and decisions including quality , timelines and resources related to the conduct of clinical research ... and proactively communicates progress, risks, issues or changes that may impact quality , timelines and/or budget; provide CDM program level updates to collaborators… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …relevant advancements to optimize system performance and functionality. **- Data Quality , Testing and Release Management** Establish and enforce robust data ... regularly test, audit and validate HR data to maintain high data quality standards. Conduct system audits, optimize performance, and troubleshoot technical issues.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices: Reinforces labeling ... best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners. + Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan for FDA meetings for assigned product. Liaise,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data. - Drug Development Strategy: Provides input to multiple aspects of ... the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. - CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted partner, provide… more