- 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)
- …process, knowledge of clinical regulatory documents, and hands‑on experience in regulatory affairs . The student should have strong interest in cancer ... independently and will also be expected to proactively collaborate with colleagues. The Regulatory Affairs department works in all of our therapeutic areas,… 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
- 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
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... SMEs, including leading cross-functional teams, to drive process improvements, streamline operations , and achieve business objectives on a global scale. + Deep… 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
- Pfizer (Parsippany, NJ)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs \#LI-PFE ... Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication… more
- Pfizer (New York, NY)
- …CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market Access, Business ... **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real World...care projects executed by RWE scientists and the Clinical Affairs & Operations teams, restructuring priorities as… more
- City of New York (New York, NY)
- …Medical Affairs , such as case management of patients with drug-resistant TB, regulatory affairs and the evaluation of newly arrived immigrants and refugees ... clinical data from surveillance registries and electronic medical records 3) Assist the Regulatory Affairs Unit in drafting Commissioner's Order on patients who… more
- The Mount Sinai Health System (New York, NY)
- …administrative, operational, and programmatic intricacies within the Cancer Institute among regulatory affairs , research finance, clinical operations , ... standards. Works closely with Tisch Cancer Institute offices (ie Quality assurance, regulatory affairs , disease specific clinical trial managers). + In… more
- Merck (Rahway, NJ)
- …Our team plays a critical role in managing the systems that support the Regulatory Affairs group, enabling the seamless integration and labeling of products to ... of the systems we manage. This internship provides an opportunity to gain practical experience in the integration of...capabilities to ensure they meet the needs of the Regulatory Affairs group. + Collaborate with IT… more
- The Mount Sinai Health System (New York, NY)
- …. The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. ... the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with cross-functional teams to… more
- The Mount Sinai Health System (New York, NY)
- …and licensure surveys. **RESPONSIBILITIES** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs and facilitates ... **JOB DESCRIPTION** A member of MSHS regulatory team, the Accreditation Specialist is a key...experience in a clinical healthcare environment. Experience in clinical operations and/or experience working in performance improvement, patient safety,… more
- Merck (Rahway, NJ)
- …to see if we are the right company for your long-term goals. Our company's Regulatory Affairs teams bring new medical advancements to the world by facilitating ... products, practices and solutions to the world. The Global Regulatory Affairs and Clinical Safety (GRACS) Business...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... to continue making a difference, and new people to make a difference with. **The opportunity ** This role can be based in Parsippany, NJ or West Chester, PA Senior… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and activities + Collaborate closely with cross-functional teams, including R&D, regulatory affairs , marketing, sales, and finance, to drive alignment ... operational delivery systems for Teva's biosimilars. Examples include private label operations , co -manufacturing, off shore transfers and TPIG collaboration. In… more