- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced… more
- 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Merck & Co. (North Wales, PA)
- …trial objectives.Liaises with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... and regulatory documents. You'll be at the heart of a...trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... Identify new analytical techniques and technologies and lead their implementation. Review analytical instrument and equipment calibration, qualification and maintenance… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Merck & Co. (North Wales, PA)
- …scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Merck & Co. (Rahway, NJ)
- …on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data/medical protocol deviations in collaborations with ... . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data...clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a strong collaborator across MAPA and NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no surprises and is seen as a ... pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad… more
- Twist BioScience (South San Francisco, CA)
- …, Customer, and Twist requirements. In this position you will report to the QC manager .What You'll Be Doing Review and release products based on established QC ... process quality reports by collecting, analyzing, and summarizing information and trendsWrite/ review product quality documentationFollow regulatory and ISO 13485… more
- BURNCO LLC (Henderson, CO)
- …business acumen and exceptional relationship-building abilities? BURNCO is seeking a General Manager to lead our Ready-Mix division in Colorado. Join us in building ... and collaborate with the HSE team to ensure world-class safety and regulatory compliance Proactively address safety and environmental risks to protect employee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written… more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... shape the future of healthcare.Essential Responsibilities:Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through… more
- NY CREATES (Albany, NY)
- …facilities, semi-conductor tools and support equipment with respect to site and applicable regulatory standards. Managing the review and comment on third party ... epicenter of high-tech innovation and commercialization. Job Description: JOB SUMMARY The Manager of Health and Safety is responsible for the management of the… more
