- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… more
- Ascendis Pharma (Princeton, NJ)
- …working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference in ... incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),...and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares… 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
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… 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
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… 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
- Caris Life Sciences (New York, NY)
- …responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position ... clinical database. + Support and adhere to Good Clinical Practices (GCP) guidelines, FDA , Institutional Review...years of experience in data collection activities within a GCP/ clinical research regulatory environment. + Knowledgeable in… more
- Ascendis Pharma (Princeton, NJ)
- …programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact ... advocacy groups. + Work with internal stakeholders including Commercial, Legal, Regulatory , Clinical Development, Clinical Operations, Compliance,… more
- Taiho Oncology (Princeton, NJ)
- …preferred. Knowledge, Skills, and Abilities: + 8-10 years Hematology / Oncology Medical Affairs and Clinical experience preferred. + At least 2-5 years' ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Bristol Myers Squibb (Princeton, NJ)
- …health and optimize product benefit-risk profiles. The VP works cross-functionally with clinical , regulatory , medical affairs , quality, and commercial teams ... regulatory inquiries. Cross-Functional Leadership and Stakeholder Engagement . Partner with clinical , regulatory , and medical affairs teams to integrate… 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
- Philips (Mercerville, NJ)
- …publications, study reports, white papers and regulatory writing needs of Philips Clinical Affairs Department **Your role:** + Collect, appraise and analyze ... to medical writing for the Ultrasound Clinical Affairs group. Collaborate with internal (project owners, regulatory...compliance with SOPs and regulations. + Knowledge of Good Clinical Practice (GCP), FDA regulations and ISO… more
- Pfizer (New York, NY)
- …and computational components or commensurate professional experience, + Experience assisting regulatory experts with new drug applications with FDA and ... **ROLE SUMMARY** The Platform: The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and… more
- Novo Nordisk (Plainsboro, NJ)
- …stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... + Collaborate with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to… more
- Integra LifeSciences (Princeton, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs . + Generate technical ... as part of a cross-functional team (Manufacturing, Design Quality, Regulatory , Quality Assurance, Product Development, Engineering, Facilities, Materials Management,… more
- Integra LifeSciences (Plainsboro, NJ)
- …may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Effectively implement problem ... are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO). + Initiate, develop and implement IQ/OQ/PQ validations for… 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