CT Submission Specialist Bristol Myers Squibb
InterviewGIG, San Francisco, California, United States, 94199
Position Summary / Objective
Support the creation and coordination of the operational deliverables for FDA submissions Position Responsibilities
Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables. Supports the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations. Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents. Ensures documents are formatted appropriately and Submission Ready Compliant (SRC). Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution. Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items. Other duties assigned to support Clinical Trials. Degree Requirements
Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience. BS/BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 1-2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus. Experience Requirements
1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field. Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma. Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred. Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies. Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
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Support the creation and coordination of the operational deliverables for FDA submissions Position Responsibilities
Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables. Supports the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations. Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents. Ensures documents are formatted appropriately and Submission Ready Compliant (SRC). Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution. Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items. Other duties assigned to support Clinical Trials. Degree Requirements
Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience. BS/BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 1-2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus. Experience Requirements
1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field. Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma. Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred. Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies. Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
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