- Novo Nordisk Inc. (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 ... program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Eisai, Inc (Nutley, NJ)
- …Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic… more
- Merck & Co. (Rahway, NJ)
- …needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …colleagues in Lexington, MA and Princeton, NJ, as well as the broader Global Regulatory Affairs (GRA) organization Serves as an influential leader within Novo ... make a difference? The Position We are seeking a Senior Director, Global Regulatory Portfolio Lead who...an as needed basis. Relationships Reports to the VP, Regulatory , Quality & Clinical Reporting, East Coast… more
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... FULLY REMOTE Regulatory Writing Senior Manager ln this...responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports,… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director May Be Responsible For:Evaluating pre- ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist)...cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical … more
- Merck & Co. (Rahway, NJ)
- …Desire and ability to learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements Ability to ... Activities may include, but are not limited to: Creates and develops clinical databases and data transfer files according to written specifications. Ensures… more
- Merck & Co. (Rahway, NJ)
- …devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with… more
- Merck & Co. (Rahway, NJ)
- …Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a highly matrix-based ... resourcing for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO) Senior , Regional and local team to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …environment with other functional groups (eg. Regulatory , Medical Writing, Med Affairs , Commercial) In-depth knowledge of Good Clinical Practice (GCP) and ... collaboration with other areas of Global Development and US Clinical , Medical and Regulatory (CMR). Your skills,...and clinical partners to ensure delivery of clinical objectives within established timelines and budget Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 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. (Rahway, NJ)
- …immunoassay-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the ... validation immunoassay-based assays that are deployed in support of clinical trials. The candidate for this Senior ...of clinical trials. The candidate for this Senior Scientist position should have strong technical expertise in… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory … more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... 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 20-30% overnight travel required. Position is ... About the Department The Clinical , Medical and Regulatory (CMR) department...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
