- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Novo Nordisk (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Novo Nordisk (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Mount Sinai Health System (New York, NY)
- … Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and ... regulatory ); MS degree or advanced certification in regulatory affairs or clinical research...Proficient with MS Word and Excel + Experience with FDA , EMA or other global health authority submissions is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... + Bachelor's degree in Nursing + Minimum of 6 or more years of experience in clinical research experience. + Working knowledge of FDA and DHHS regulations, Good … more
- Merck (Rahway, NJ)
- …such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... clinical research and clinical trial methodologies. + Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines. + Excellent… more
- Pfizer (New York, NY)
- …Medical Outcomes organizations + Maintains strong working relationships with Global Medical Affairs Leads, Outcomes & Evidence, Clinical Sciences, PRD and ... mission is to inspire the medical community to enhance clinical practice and public health, driven by a deep...a thorough understanding of the processes associated with Medical Affairs . Working knowledge of lifecycle management and regulatory… more
- Pfizer (New York, NY)
- …care and (e) provide therapeutic area/product information for regional and other Medical Affairs and/or clinical development needs as necessary and approved by ... with Global Medical Affairs Leads, US Medical Affairs Brand Leads, Clinical Sciences, and Medical...Vaccines/AV, as needed **Operational Management:** + Anticipate evolution of FDA and other US regulations and guidance that impact… more
- Novo Nordisk (Plainsboro, NJ)
- …in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs , Patient Safety ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... and programs in accordance with company processes, SOPs, and FDA /ICH guidelines and regulations. The incumbent will lead the...phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both… more
- Novo Nordisk (Plainsboro, NJ)
- …Strategy and Evidence (CDSE) but more broadly within Clinical , Medical and Regulatory (CMR), Market Access and Public Affairs (MAPA), as well as ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Sanofi Group (Bridgewater, NJ)
- …of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities. + Collaborate ... work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... + Excellent statistical knowledge and project planning skills + Knowledge of clinical trial research and regulatory requirements + Familiarity with SDTM/AdaM… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... medicine studies. + Collaborates with cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory , PK/ADME, Pharmacovigilance,… more
- Integra LifeSciences (Plainsboro, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs . + Generate technical ... and provide practical manufacturing solutions for complex CAPAS under appropriate regulatory guidelines for Medical Device Manufacturer. + Support the business with… more
- Integra LifeSciences (Plainsboro, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs . + Generate technical ... technical investigation and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturer. + Effectively implement… more