Start-Up Analyst Jr

Start-Up Analyst Jr 
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 Start-Up Analyst Jr., you'll play a crucial part in transforming clinical trial plans into action. You'll be responsible for navigating the complex regulatory landscape, coordinating with sites, health authority, and ethics committees to ensure trials activate efficiently and compliantly. This is a role where your attention to detail and proactive collaboration directly impact how quickly we can bring new therapies to patients.
Your day-to-day responsibilities will include:
• Executing start-up activities and regulatory submissions for assigned trials, ensuring compliance with ICH GCP regulations and local requirements. 
• Preparing, reviewing and submitting Health Authority and Ethics Committee dossiers, tracking regulatory milestones and timelines at country and site levels.
• Customizing and translating key trial documents such as Informed Consent Forms, patient materials, labels and Clinical Trial Application documents.
• Performing quality control and uploading documents to eTMF while maintaining study information in local and national registries.
• Liaising with cross-functional trial teams, clinical sites, vendors and external stakeholders to ensure alignment and timely delivery of start-up activities.
• Identifying potential risks at site level and suggesting actions to prevent or mitigate issues that could impact trial progress.
• Supporting pharmacovigilance activities by selecting and distributing relevant safety documentation to stakeholders.
• Ensure the provision of medication to the sites participating in post-trial supply programs.

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 are looking for someone who thrives in a fast-paced, detail-oriented environment and enjoys solving complex regulatory puzzles. To succeed in this role, you'll bring: 
• Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred). 
• 1+ years of experience in clinical trials, including regulatory affairs or submission management/coordination. 
• Basic understanding of regulatory guidelines, dossier requirements, and global clinical trial application processes. 
• Strong written and verbal communication skills, with the ability to build relationships with internal and external stakeholders at all organizational levels. 
• Basic project management capabilities including tracking, planning and prioritization to manage multiple submissions simultaneously. 
• Basic critical thinking and analytical skills to evaluate risks, identify opportunities, and work with high attention to detail.
• Familiarity with digital tools, clinical trial management systems and publishing software.

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 
For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. To complete your application, click on "Apply now", attach your CV and follow the instructions. 

Deadline 
Please apply before April15th.