- Merck & Co. (North Wales, PA)
- …five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position The Therapy Area (TA) head is accountable for setting an integrated medical affairs strategy, scientific engagement plan and execution of that plan for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and field alignment directors. They will also be the senior strategic representative of medical affairs in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Merck & Co. (Rahway, NJ)
- …The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial...approvals and systems are in place to maintain the scientific , technical and regulatory quality of all… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs (GRA) Global Labeling function, combining knowledge of scientific , regulatory , and business perspectives to ensure compliance with evolving ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and ... Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Novo Nordisk Inc. (Miami, FL)
- …a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between NNI and key ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and … 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 ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal ... We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development.The primary role of the Senior Manager, Business… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …to ensure safe and effective use of Jazz Pharmaceuticals' productsAttend and provide scientific support of Medical Affairs activities and scientific sessions ... opinion leaders preferredThorough understanding of applicable federal and state regulatory requirements for field-based scientific personnelDemonstrated ability… more
- ThermoFisher Scientific (High Point, NC)
- …the FDA. Additionally, this position requires representation and advisory support to the Regulatory Affairs (RA) team in R&D project teams, providing expertise ... **Job Description** When you join us at Thermo Fisher Scientific , you'll be part of a hard-working and driven...Assessment of RA changes and change controls + Represent Regulatory Affairs in project teams + Pharmacovigilance… more
- ThermoFisher Scientific (Wilmington, NC)
- …communities depend on - now and in the future. **Discover Impactful Work:** The Senior Director, Regulatory Affairs Functional Lead, FSP, provides strategic ... **Job Description** At Thermo Fisher Scientific , you'll discover meaningful work that makes a...direction, leadership and management to the FSP Regulatory Affairs business segment + Accountable for… more
