Global Study Start-Up Lead: Regulatory Submissions & Access

Novo Nordisk Pharma; Latina; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Incentives and benefits

Global healthcare company environment

Collaborative culture

Impact on patient access

Descrizione del lavoro

Novo Nordisk Pharma seeks a qualified professional to drive study start-up processes, enabling timely trial initiation. You will handle regulatory submissions, coordinate cross-functional teams, and ensure ICH-GCP compliance across projects withinItaly.

The role emphasizes collaboration with local Italian teams, quality documentation, and stakeholder management to accelerate patient access to investigational therapies in a global portfolio.

Competenze

• 3–5 years' experience in clinical trial start-up/regulatory submissions or clinical operations in pharma/biotech.
• Solid knowledge of ICH-GCP and local regulatory requirements.
• Experience with regulatory submissions and timelines.
• Proficiency in Italian and English.
• Applications from other locations in Italy considered.

Mansioni

• Manage regulatory authority and ethics committee submissions across projects to obtain timely approvals.
• Coordinate with internal and external stakeholders to collect, review and submit start-up documents through the CTIS portal.
• Ensure compliance with ICH-GCP, local regulations, and Novo Nordisk SOPs throughout trial conduction.
• Contribute to process improvements and share best practices across local and global start-up teams.
• Maintain accurate trial master file documentation and start-up tracking systems.
• Collaborate with monitors, clinical trial administrators, and legal teams to negotiate and finalize site contracts and budgets.
• Establish partnerships with clinical trial managers to drive study success and patient impact.

Conoscenze

Regulatory submissions

Stakeholder management

Cross-cultural collaboration

ICH-GCP knowledge

Project coordination

Formazione

BSc or MSc in Life Sciences/Pharmacy/Nursing

Strumenti

CTIS portal

Descrizione del lavoro

Novo Nordisk Pharma seeks a qualified professional to drive study start-up processes, enabling timely trial initiation. You will handle regulatory submissions, coordinate cross-functional teams, and ensure ICH-GCP compliance across projects withinItaly.

The role emphasizes collaboration with local Italian teams, quality documentation, and stakeholder management to accelerate patient access to investigational therapies in a global portfolio.