Employer Industry: Clinical Research Organization (CRO)

Why consider this job opportunity:
- Opportunity for career advancement through structured mentoring and leadership courses
- Generous health benefits and vacation packages, promoting work-life balance
- Hybrid work-from-home opportunities available
- Paid parental leave and support for ongoing education and training
- Opportunity to make a significant impact on treatments for chronically and critically ill patients

What to Expect (Job Responsibilities):
- Publish submission documents to FDA specifications in eCTD format
- Quality check documents authored by others and ensure compliance with regulatory authority standards
- Manage receipt of submission components and workflow for high-quality submissions
- Support internal functional groups in compliant use of eCTD authoring guidelines
- Participate in regulatory initiatives aimed at enhancing internal standards and procedures

What is Required (Qualifications):
- Bachelor's degree in allied health, nursing, pharmacy, health/natural science, or equivalent work experience
- Minimum of 2 years of experience in quality checking, authoring documents, and/or eCTD submissions
- Understanding of eCTD structure and components
- Experience with eCTD submission building and validation preferred
- Working knowledge of relevant software tools such as Adobe Acrobat Professional and eCTD software preferred

How to Stand Out (Preferred Qualifications):
- Experience with StartingPoint templates and Authoring templates
- General regulatory submission management experience
- Familiarity with the CTI Style Guide and internal SOPs

#ClinicalResearch #eCTD #CareerAdvancement #WorkLifeBalance #HealthcareImpact

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