- Merck & Co. (Rahway, NJ)
- …to-demonstrate your leadership and technical skills as part of a global , cross-functional team. You will apply project management, communication, and collaboration ... the operational planning, feasibility, and execution of a clinical trial .- May serve as the clinical trial ...and skills: A plus with prior experience on managing global pediatric clinical trials (age 6 +), including managing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to ... WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations...as building a network with key staff members including senior management, the global functional leads, Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... will require close collaboration with the Heads of Field Medical worldwide, Global Medical Strategy Teams, Global Medical Training, and Scientific… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by ... bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core...Clinical Lead alongside other Clinical Leads to deliver large, global trials. * Identify clinical stakeholder landscape for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager leads company operational activities to ... WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations...as building a network with key staff members including senior management, the global functional leads, Regulatory… more
- Pfizer (New York, NY)
- …develop resolutions to meet productivity, quality and client satisfactions goals. As a Senior Manager , your advanced knowledge of the principles and concepts in ... and timely communication between the core Team and functional management, senior management, and external partners. + Participate in regional operations meetings… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle ... contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization's GxP… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... sites accross more than 60+ countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures. The GCS Clinical Planning… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a...other departments; Member of the Clinical Study Team and Global Clinical SubTeam + Develops/maintains understanding of therapeutic disease… more
- Merck (Rahway, NJ)
- …to demonstrate your leadership and technical skills as part of a global , cross-functional team. You will apply project management, communication, and collaboration ... the operational planning, feasibility, and execution of a clinical trial . * May serve as the clinical trial...and skills:** A plus with prior experience on managing global pediatric clinical trials (age 6 +), including managing… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …alternative solutions, acquires buy-in from organization; Ensure appropriate communications between IOPS and global RA in a timely manner + Participate in global ... support CMC/CP prduct development activities. Proactively initiating and managing communications between Global RA and IOPS to ensure they happen in a timely manner… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Evaluate, interpret, and present complex scientific clinical data as required for senior management on a global basis. + Support regulatory safety reporting ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Pfizer (Peapack, NJ)
- …related field + Prior work with a matrixed and decentralized teams, around clinical trial , and drug development projects + Strong verbal and written ability with the ... Experience with change management + Experience with working with international/ global organizations Candidate demonstrates a breadth of diverse leadership… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills to ... The ** Senior Clinical Study Lead** (CSL) is expected to...considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must,… more
- Merck (Rahway, NJ)
- …leadership, technical skills, and scientific acumen as part of a global , cross-functional team. **Job Responsibilities:** Responsible for leading specific aspects of ... Serving as the lead clinical scientist on a clinical trial team. + Leading medical monitoring team in review...study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables. + Ensuring CRF design supports… more
- J&J Family of Companies (New Brunswick, NJ)
- Sr. Director, Senior Safety Officer- Johnson & Johnson Enterprise Innovation - 2406193938W **Description** Johnson & Johnson, is recruiting for a Senior Safety ... single case signal detection activities for selected products. The Senior Safety Officer (SSO) has responsibility for implementing the...of the Safety Management Teams (SMTs) and / or manager or Medical Safety Officers (MSOs) who lead SMTs,… more
