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Bristol Myers Squibb
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San Diego, California
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practices with regards to planning, execution, interpretation and regulatory submission of clinical projects ... the company in interfaces with regulatory agencies globally
Drives strategy for processes
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Bristol Myers Squibb
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San Diego, California
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Senior Manager of Biostatistical Programming at RayzeBio will be accountable for development of clinical ... clinical studies to support CSRs and future regulatory submissions.
Create SAS macros/applications to
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Bristol Myers Squibb
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San Diego, California
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trials.
• May simultaneously function as lead Clinical Data Manager for multiple clinical trials ... learn new systems as needed.
• Contribute to SOP development and updates to meet regulatory
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Bristol Myers Squibb
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Brisbane, California
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leadership)
Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with ...
Provision of information required by Protocol Manager for development of trial budget, CRO scope of work
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Bristol Myers Squibb
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San Diego, California
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, disease area and relevant science in order to meet regulatory and disease strategy targets
Provides ... and ongoing review of the literature
Keeps abreast of development and regulatory issues related
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Bristol Myers Squibb
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San Diego, California
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and regulatory guidelines
Understanding of scientific publications
Clinical trial ... , governmental, and regulatory requirements.
Understands treatment paradigms, competitive landscape and
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Bristol Myers Squibb
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Brisbane, California
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activities for the pipeline and supports late stage portfolio for regulatory, translational development and ... , regulatory interactions and label negotiations
Proven ability to work with global disease teams to
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Bristol Myers Squibb
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San Diego, California
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overseeing a diverse portfolio of responsibilities ranging from regulatory compliance to contractual ... support for supply chain, clinical trials and regulatory issues and will evolve to also include supporting
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Bristol Myers Squibb
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Brisbane, California
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strategies for our pipeline as well as regulatory support including pre-clinical and translational sections ... , commercial, regulatory and diagnostics as well as engage external academic collaborators/Key opinion leaders
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Bristol Myers Squibb
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San Diego, California
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, official reports and SOPs for internal and external purposes, internal documents/reports for regulatory
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Bristol Myers Squibb
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Brisbane, California
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comprehensive programming expertise to clinical project teams to support the development, regulatory approval ... consistently applying standards and complying with regulatory requirements, guidance, and corporate and
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Bristol Myers Squibb
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San Diego, California
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Ensure studies are designed to meet regulatory, quality, medical, and access goals
**Position ... functional author for Regulatory submissions, study reports, and publications
Independently synthesizes
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Bristol Myers Squibb
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San Diego, California
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development and regulatory processes, and the ability to assess and drive the deployment of tools and best ... clinical development teams and successfully advancing development candidates to global regulatory
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Bristol Myers Squibb
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San Diego, California
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support development
Serving as principal functional author for Regulatory submission, study reports ... of the literature
Keeps abreast of development and regulatory issues related to other
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Bristol Myers Squibb
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San Diego, California
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working knowledge of relevant regulatory and compliance issues related to the MVL role
Ability to
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Bristol Myers Squibb
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Los Angeles, California
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working knowledge of relevant regulatory and compliance issues related to the MVL role
Ability to
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Bristol Myers Squibb
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Brisbane, California
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knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy ... conferences and ongoing review of the literature
Keeps abreast of development and regulatory issues
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Bristol Myers Squibb
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San Jose, California
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in cross-functional networks.
Current working knowledge of US legal, regulatory, and compliance
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Bristol Myers Squibb
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San Francisco, California
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in cross-functional networks.
Current working knowledge of US legal, regulatory, and compliance
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Bristol Myers Squibb
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Brisbane, California
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) activities
Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
Qualifications & Experience
Degree in
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Bristol Myers Squibb
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Los Angeles, California
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and regulatory guidelines
Understanding of scientific publications
Clinical trial ... , governmental, and regulatory requirements.
Understands treatment paradigms, competitive landscape and
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Bristol Myers Squibb
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Brisbane, California
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adapting best practices and maintaining rigor in light of emerging regulatory guidelines for mechanistic
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