- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery of ... is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThis position will… more
- Merck & Co. (Rahway, NJ)
- …work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs -CMC to ensure that validated methods are appropriately transferred from ... management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory ...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding… more
- Merck & Co. (Rahway, NJ)
- …may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the position may be responsible… more
- Merck & Co. (Rahway, NJ)
- …interfacing with other functional areas (eg project management, manufacturing, quality, regulatory affairs ) and external partners to drive project milestones ... experimental design & data analysis, authoring of technical reports, regulatory submissions and patent applications.- Active participation on formulation development… more
- Merck & Co. (Rahway, NJ)
- …clinical trials.- Close partnership with supply chain colleagues from Quality, Regulatory Affairs , Facilities Management, Engineering, and Analytical will be ... and compliance standards. A successful candidate should have GMP facility operations experience, an affinity for hands-on problem solving, and excellent leadership… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, ... and data transfer files. This role provides a unique opportunity to contribute to a team that is delivering...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …Planning & External Engagement leadership team (LT) and Director, Strategic Operations Team to conduct regular, actionable analysis and generate insights to ... professional with at least 15 years' experience in international government affairs in governments, think tanks or business associations responsible for healthcare,… more
- Haleon (Warren, NJ)
- …+ Enables the identification of emerging regulatory trends and evolving FDA expectations ** Regulatory Affairs Co -Op** The objective of the Regulatory ... see and manage their everyday health. That's an incredible opportunity . An exciting challenge. And a huge responsibility. We're...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Merck (Rahway, NJ)
- …chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC ... **Job Description** The Future Talent Program features Cooperative ( Co -op) education that lasts up to 6 months...organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification,… more
- J&J Family of Companies (Raritan, NJ)
- Regulatory Affairs Summer Intern - 2406211564W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation ... world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a...Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... assessing regulatory risk, and developing global filing strategies. + Co -lead marketing application submission teams for indications that are at regulatory… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …origin, protected veteran status, disability or any other legally protected status. Manager, Regulatory Affairs : Base Salary Range $90,000 - $120,000 \#ITCI ... CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co -founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio… more
- Merck (Rahway, NJ)
- …for the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations , Process & Systems ... Job Description The Future Talent Program features Cooperative ( Co -op) education that lasts up to 6 months...Final External Policy is the official approved version of regulatory requirements or expectations that have undergone a thorough… more
- The Mount Sinai Health System (New York, NY)
- **JOB DESCRIPTION** The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide ... who coordinates the planning, monitoring and evaluation of the Quality and Regulatory Readiness program. Participates in planned and unplanned regulatory visit… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... as an influential leader within the R&D organization to co -steward assets on cross-functional teams for assigned asset(s). The...compliance with regulatory and ethical standards in all medical … more
- Haleon (Warren, NJ)
- …in Health Sciences or related field. + 2+ years of experience in Medical Affairs , R&D, Regulatory Affairs within the consumer healthcare or pharmaceutical ... we're in control of. In an environment that we're co -creating. And a culture that's uniquely ours. Care to...us and help shape the future. It is an opportunity to be part of something special. **About the… more
- The Mount Sinai Health System (New York, NY)
- …faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety ... in federal and industry funding. This position is responsible for translating regulatory knowledge relating to human research, including federal, state, local and… more
