Start-up Analyst

Start-Up Analyst 
São Paulo/SP, Brazil 

Be at the frontline of bringing life-changing clinical trials to life. In this role, you'll ensure trials launch smoothly and on time, connecting global strategies with local realities, and helping new treatments reach the patients who need them most. 

Your new role  

As a Study Start-Up Analyst, you'll be responsible for the high-quality execution of all study start-up and submission activities at country and site level for assigned clinical trials. You'll be the driving force behind timely site activation and regulatory compliance, working at the intersection of science, strategy, and stakeholder management. 

Your day-to-day responsibilities will include: 

• Leading and managing the preparation, review, and submission of Health Authority and Ethics Committee dossiers, ensuring full compliance with ICH GCP regulations and local Brazilian requirements 

• Coordinating all study start-up activities for assigned trials, from regulatory strategy development through to site activation 

• Customizing, translating, and preparing essential trial documents such as Informed Consent Forms, patient materials, labels, and Clinical Trial Application documents 

• Performing quality control and uploading documents to eTMF, ensuring regulatory milestones and timelines are consistently met 

• Building and maintaining excellent relationships with clinical sites, Ethics Committees, Health Authorities, and cross-functional trial teams 

• Supporting clinical supply import/export processes and pharmacovigilance activities, including distribution of safety documentation to relevant stakeholders 

• Providing local regulatory insights to trial teams and contributing to continuous improvement initiatives that enhance submission processes 

Your new department  

In Product & Portfolio Strategy we drive commercial strategy, medical affairs and business development across all therapy areas. We act as a connector and compass, guiding the new Novo Nordisk portfolio for sustained competitiveness. 

As a member of the Clinical Trials team, you'll join the Study Start-Up function, which plays a vital role in connecting trial design with actual execution. Our responsibility is to ensure that clinical trials are launched smoothly in Brazil, carefully managing regulatory complexities while upholding top compliance standards. Your efforts will help speed up patient access to new treatments. 

Your skills & qualifications 

We're looking for a detail-oriented professional who thrives in a fast-paced, collaborative environment and is passionate about advancing clinical research. To succeed in this role, you'll bring: 

• Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred) 

• 2+ years of experience in regulatory affairs related to clinical trials 

• Significant experience in regulatory submissions with a solid understanding of regulatory guidelines, dossier requirements, and clinical trial application processes 

• Strong project management capabilities, including planning, tracking, prioritization, and the ability to manage multiple trials simultaneously 

• Excellent written and verbal communication skills in both Portuguese and English, with proven ability to build relationships with stakeholders at all organizational levels 

• Good knowledge with digital tools, clinical trial management systems, and publishing software 

• Critical thinking and analytical skills with high attention to detail, coupled with the ability to propose solutions to complex regulatory challenges 

• Demonstrated commitment to quality execution and compliance with ICH-GCP, regulatory requirements, and internal SOPs 

Working at Novo Nordisk   

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.  

What we offer  

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.  

More information