- Merck (Rahway, NJ)
- …Acting as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with ... Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD) leaders,...and understanding of end-to-end drug development and clinical trial processes, including related standards and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient ... vision, direction and future investments. **Responsibilities** - Oversees bioanalysis strategy from global development and global regulatory perspectives -… more
- Rockefeller University (New York, NY)
- …and carrying out clinical research study activities accomplished through the development or updating of protocols, procedures, and standards for a study ... the following: + Coordinate, facilitate, and carry out assigned clinical research study activities through the development ...assigned clinical research study activities through the development or updating of protocols and standards … more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director, Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director, Clinical Development & Medical Affairs ... - USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director, Clinical Development Medical Affairs (CDMA) drives strategy and accountability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the ... in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... clinical study safety reporting and activities. + Global Clinical Study Start-Up Documentation: Reviews all...more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred Daiichi Sankyo, Inc. is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, and business ... Director, Clinical Operations will be responsible for clinical development strategy, clinical program...standards and metrics for the execution of all clinical trials and related activities. **Qualifications** + Bachelor's Degree… more
- Merck (Rahway, NJ)
- …job aids/SOPs and participates in or leads cross-functional teams to develop global clinical development procedures. Identifies and communicates best ... Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development . Represents Early Stage Development on early… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Pfizer (New York, NY)
- …within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data ... to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose...to collect, review, monitor, and ensure the integrity of clinical data, applies standards , data review and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …outcomes (PROs), ensuring the payer perspective is incorporated in the assigned clinical development programs and the evidence needed to support optimal ... role will contribute with HEOR sections in target product profiles (TPPs), product development plans, clinical development plans, and commercialization plans… more
- Merck (Rahway, NJ)
- **Job Description** Clinical Development heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards , Trial ... first site ready. + Remove obstacles and enable the Global Clinical Trial Organization to focus on...Organization to focus on what matters. As Research and Development IT continues the transition from project / portfolio-based… more
- Pfizer (New York, NY)
- …excellence, and the highest ethical standards . He or she will lead clinical development strategy and program execution of research projects with a particular ... be responsible for creating the overarching strategy for early clinical development programs with a focus on...addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0%… more
- L'Oreal USA (Clark, NJ)
- …that the CRO adheres to regulatory requirements, ethical guidelines, and industry standards throughout the clinical studies. This involves overseeing the CRO's ... Home (https://careers.loreal.com/en\_US/content/Home) / Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 178052 Senior Clinical Scientist I, Skin Clinical & Physics… more
- IQVIA (Bridgewater, NJ)
- …Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle. * Ensure clinical quality delivery by ... as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials....and communicate appropriately to achieve objectives. * Support professional development by providing feedback to clinical team… more
- Merck (Rahway, NJ)
- …among the intellectually curious, join us-and start making your impact today. **Overview:** Global Clinical Trail Operations (GCTO) is a global organization ... responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical...Operations . Exposure to Senior level positions within the clinical development . Hands-on experience in the… more
- J&J Family of Companies (Raritan, NJ)
- …be a member of the Global Medical Affairs team, leading the conduct of a global clinical study using the portfolio of compounds at Janssen with the aim of ... clinical research and the highest personal and ethical standards . Experience in running and the conduct of global or highly complex studies is a key area of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the… more
- Stryker (New York, NY)
- …Stryker is a global leader in medical ... design and execution of regulatory-grade RWE studies to support clinical evidence needs. Working with key stakeholders, the role...the role will execute on key RWE deliverables, establish standards , and best practices for RWE study design and… more