Hybrid: Clinical Document Submission Lead

Novartis Farmacéutica; Dublin; Hybrid; EUR 55,370 - 102,830; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Minimum 14 weeks paid parental leave

Job summary

Novartis Farmacéutica is seeking a Submission Readiness Document Manager in Dublin, Ireland. This role involves managing the submission-readiness of clinical documents and ensuring compliance with regulatory requirements. The ideal candidate will have a Bachelor's degree and 3–5 years of experience in clinical development or operations.

The position offers a salary range of 55,370 to 102,830 EURO, along with potential performance bonuses and flexible working options.

Qualifications

• 3–5 years of experience in clinical development or clinical operations.
• Strong expertise in compliance and quality standards for clinical documents.
• High level of independence with the ability to manage complex priorities.

Responsibilities

• Manage submission-readiness of clinical documents.
• Ensure compliance with regulatory requirements.
• Support implementation of submission readiness strategies.
• Act as escalation point for submission readiness issues.

Skills

Clinical document management

Regulatory requirements

Project management

Strong organizational skills

Communication skills

Education

Bachelor's degree in life sciences, healthcare, pharmacy, or information management

Tools

Document management systems

Job description

Novartis Farmacéutica is seeking a Submission Readiness Document Manager in Dublin, Ireland. This role involves managing the submission-readiness of clinical documents and ensuring compliance with regulatory requirements. The ideal candidate will have a Bachelor's degree and 3–5 years of experience in clinical development or operations.

The position offers a salary range of 55,370 to 102,830 EURO, along with potential performance bonuses and flexible working options.