- Actalent (Hackensack, NJ)
- The Project Manager in Clinical Trials will oversee multiple investigator -initiated clinical trials, ensuring the successful management and execution from concept to ... compliance efforts and statistical analysis. Responsibilities + Manage multiple investigator -initiated clinical trials. + Oversee reports and assist with statistical… more
- WuXi AppTec (Cranbury, NJ)
- …for assigned projects, such as acting as study director/ principal investigator , and assumes an executing responsibility for each assigned PKPD studies. ... standards and practices. **Responsibilities** + Serve as Study Director, Principal Investigator , or Project Coordinator for multiple complex PK/PD studies, acting as… more
- Merck (Trenton, NJ)
- …a holistic lifecycle support for pre-approval inspection (PAI) for the company 's growing pipeline of products and launches. + **CAPA Management:** Collaborate ... with company and CMO teams to develop, monitor, and verify...experience working within a health authority as an inspector, investigator , compliance officer, or assessor. + Expertise in developing… more
- Merck (Trenton, NJ)
- …leaders and decision makers. This is a headquarters-based position in Our Company Research Laboratories Value & Implementation Global Medical and Scientific Affairs ... committees, payers, public groups, government officials, medical societies) about Our Company 's emerging science. + Organizes global expert input events (advisory… more
- Merck (Rahway, NJ)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... the division + Interact with key stakeholders across department, division, and company . Role requires a proactive approach and leadership driving toward study goals.… more
- Merck (Rahway, NJ)
- …+ Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets + ... HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical Monitors in Clinical… more
- Grifols Shared Services North America, Inc (Freehold, NJ)
- …want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of ... aligned with the global and US medical plan to support innovation and company goals. Provide medical guidance and consultation to internal stakeholders and educate… more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... the Prostate Cancer therapeutic area and set the strategy for both internal company programs and external facing interactions. This job will effectively lead and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." ... clinical pharmacology documents for regulatory filings including annual reports, investigator 's brochure, IND/NDA applications and pediatrics development plans. +… more