CT Submission Specialist

Job Title 

GDO Submission Document Specialist

Division 

Research & Development

Functional Area Description

Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission

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).