Start-Up Specialist
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Clinical Development Center
Mexico City
Are you passionate about clinical trials and regulatory submissions Do you want to play a key role in ensuring high-quality execution of study start-up activities If so we are looking for a Start-Up Specialist to join our team and make a difference. Read more and apply today!
Your new role
As a Start-Up Specialist at Novo Nordisk you will lead coordinate and manage the execution of start-up activities for assigned trials. Your responsibilities will include:
- Prepare review and submit Health Authority (HA) and Ethics Committee (EC) dossiers in compliance with ICH GCP regulations and local requirements.
- Develop regulatory strategies and start-up plans in collaboration with trial teams and SSU Managers.
- Perform quality control and ensure timely site activation by managing essential documents and training plans.
- Engage with cross-functional teams clinical sites and external stakeholders to ensure alignment and timely delivery of start-up and submission activities.
- Provide local regulatory insights and support continuous improvement initiatives related to study start-up and compliance.
- Ensure adherence to ICH GCP regulatory requirements and internal SOPs while contributing to inspection readiness and audits.
Your new department
As part of International Operations you will join our largest operational unit. Covering 194 countries and 95% of the worlds population more than 18000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition we continue to be the growth driver for Novo Nordisk and to improve health at scale across the globe.
You will be part of the Clinical Development team where we strive to deliver high-quality clinical trials that make a difference for patients worldwide. The department operates in a fast-paced and dynamic environment fostering collaboration and innovation. Based at Mexico City you will join a global team dedicated to driving excellence in clinical development and regulatory submissions. Together we aim to ensure efficient trial initiation and regulatory compliance while maintaining a supportive and engaging atmosphere.
Your Skills and Qualifications
Need to have:
- A bachelors degree in Life Sciences Pharmacy or a related field (advanced degree preferred).
- 3 years of experience in clinical trials regulatory affairs or submission management.
- Extensive experience in regulatory submissions and a thorough understanding of global clinical trial application processes.
- Advanced English
Nice to have: - Proficiency using Veeva 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 FacebookInstagramXLinkedInandYouTube.
To complete your application click on Apply now attach your CV and follow the instructions.
Deadline
Please apply before February 12th 2026
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.
