- Genmab (Plainsboro, NJ)
- …organization.In this role, you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to implement the ... include, but is not limited to: Act as US regulatory lead and FDA contact person for...compliant submissions in line with the overall strategy Drive compliance with regulatory guidelines through prompt communication… more
- Genmab (Plainsboro, NJ)
- …onsite presence 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory...working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelp improve metrics ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management: Demonstrate fiscal discipline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient ... regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement knowledge management technology ... existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...Support program vendors and professional services (including technology and platform support). Essential Functions Partners with PSS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a fast paced and dynamic, growing environment.Strong understanding of regulatory and compliance requirementsExcellent oral and written communication skills ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... business and distribution license applications and renewals and acting as lead paralegal support and coordinator of legal matters, under attorney supervision,… more
- Genmab (Plainsboro, NJ)
- …technical skill development.Oversee resource allocation and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific ... and GCP audits and inspections.Mitigate operational risks and implement regulatory changes in collaboration with stakeholders.Strategic Planning and Operational… more
- Genmab (Plainsboro, NJ)
- …architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, ... working in agile and product-oriented development teamsSolid experience with Compliance ( regulatory and industry-specific) and Security frameworksDemonstrated… more
- Genmab (Plainsboro, NJ)
- …ensure standards are met for test automation, quality, performance, security, and compliance .Stay current on leading practices and modern technology trends in ... adhering to well-architected-frameworks and delivery standards for excellence in execution. You'll lead a skilled team, with the potential to expand, focusing on… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... spanning neuroscience and other therapeutic categories employing our proprietary science and technology .We truly believe that to innovate and to set us apart, we… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
