Start-up Regulatory Specialist at Novo Nordisk

The Position

As a Start-up Regulatory Specialist, you will manage and execute the start-up activities related to contracting of sites and investigators in the allocated clinical trials in compliance with local regulations, Novo Nordisk procedures and protocol requirements to deliver reliable, high-quality data and study subject protection to activate sites prior First Patient First Visit in the country. You will also establish and maintain professional relationships with internal and external stakeholders.

Your main accountabilities will be:

• Manage and execute the start-up activities in the allocated clinical trials in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements.
• Ongoing trials – performing submissions (incl. translation/reduction of docs.) CONNECT, RIM, COSMOS updates.
• Prepare Part II and selected Part I documents for submission (incl. translation and redaction,) and to handover the CTA package to EU Submission Hub within selected timelines - completion of EMA templates; obtain local insurance certificate.
• Check the completeness and correctness of all documents/materials for SIV in close collaboration with the CRA and CDC Clinical Trial Administrator.
• Participate in kick-off meetings and trial TCs with the EU Submission Hub and CDC Start-up Trial Managers.

Qualifications

To be successful in this role, you need to have:

• Min. 3 years of experience in pharma industry, preferably in start-up activities, previous CRA experience must have.
• Min. bachelor’s degree in health science.
• Ability to build and maintain strong working relationships with internal and external stakeholders. Strong communication skills, attention to detail, very good organizational skills.
• Team oriented personality with high degree of flexibility - close collaboration with the sites, stakeholder, vendors, and regulatory team.
• High focus on delivery and quality.
• Fluent English.
• Knowledge of local legislations related to clinical trials.
• High result orienting in driving of start-up milestones according to CDC Start Up KPIs.
• Ability and willingness to adjust quickly to new situations in a continuously developing environment.
• Proven decision making and problem-solving capabilities.