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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care. Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical Affairs.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvote
Associate Director, Medical Affairs Cell Therapy, Franchise Strategy And Operations, Project Manager
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The Associate Director, Strategy and Operations is responsible for partnering with colleagues in Medical Affairs and in other functions including Commercial, both Heme and Cell Therapy to lead or support Strategic Planning responsibilities.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Responsible for upholding regulatory and welfare standards as they pertain to laboratory animal care, husbandry, facilities, and the overall animal macro environment. Must have a solid foundation in the care and maintenance of USDA (Animal Welfare Act) regulated species as well as the regulatory requirements for maintaining those animals.
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Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH.
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Experience with CERCLA, RCRA, Brownfields and Voluntary regulatory programs, including local state regulatory programs. Preparation and editing of technical and regulatory reports.
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Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
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Develop and maintain data lineage documentation and mappings to support data governance, regulatory, compliance, and data lineage analysis activities. Strong understanding of data governance principles, data quality management concepts, and regulatory requirements.
$179,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelines. 10+ years experience in pharmaceutical industry Medical Affairs specifically.
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Ensures all promotional materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence to administrative policies and procedures; Ensures collaborative and compliant communication between marketing and other cross-functional teams (i.e., Medical Affairs, Sales, Regulatory Affairs, Operations, etc.
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In-depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D, and Commercial work. Biotech/Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function.
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regulatory affairs jobs Title: pediatric Company: Maxim Healthcare Services in Princeton, NJ
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