Job Description

This is an exciting opportunity to be a part of the team which you will execute of all study start-up and submission activities.

Your new position

As Study Start-Up (SSU) Specialist you will be responsible for high-quality execution of all study start-up and submission activities at the country and site level for assigned trials, ensuring timely site activation and regulatory compliance. You will drive cross-functional collaboration with study teams, vendors, and external stakeholders to ensure efficient trial initiation, regulatory submissions, and timely site activation

Some of your responsibilities will be to:

• Lead, coordinate and manage the preparation, review and submission of Health

Authority (HA) and/or Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations, local requirements, and Novo Nordisk processes.

• Co-develop regulatory strategy and SSU plans for assigned trials with TMs and SSU Manager, in alignment with CDC strategy and industry best practice.
• Perform Quality Control (QC) and upload documents to eTMF, ensuring regulatory milestones and timelines are met at country and site levels.
• Customize, translate and/or prepare key documents, such as Informed Consent Forms (ICFs), patient materials, Labels, and Clinical Trial Application (CTA) documents at country and site levels, including updates requested by EC and/or HA.
• Perform and coordinate core label reviews in collaboration with Regulatory, Clinical, and Quality teams to ensure labels meet protocol and regulatory requirements.
• Provide local regulatory insights and intelligence to trial teams and Global/Regional stakeholders.
• Support continuous improvement and innovation initiatives related to SSU, compliance and regulatory submissions processes

• Proactively identify and escalate start-up compliance risks or process gaps.

About The Department

Clinical Development Centre Türkiye is responsible for all clinical operations activities within

Türkiye and project management of clinical studies conducted in Saudi Arabia, Lebanon, Algeria, and Morocco. The team consists of more than 80 employees as TAs team members, Clinical Operations Excellence team members and start up team members

Your new skills & qualifications

You hold bachelor's degree in Life Sciences, Pharmacy, or a related field is required. You have at least 3+ years of experience in clinical trials, regulatory affairs, or submission management. You have excellent verbal and written communication in both Turkish and English. Further sought-after skills are:

• Extensive experience in regulatory submissions and a thorough understanding of regulatory guidelines, dossier requirements, and global clinical trial application processes.
• Proficiency in digital tools, clinical trial and submission management systems and publishing software
• Strong project management capabilities, including tracking, planning and prioritisation​
• Ability to creatively solve complex problems and drive the development of practical solutions.
• Excellent written and verbal communication, presentation skills, and expertise in managing relationships with internal and external stakeholders at all organisational levels.
• Strong critical thinking and analytical skills to evaluate risks, identify opportunities, and work with high attention to detail ​
• Ability to champion the implementation of agile ways of working and adoption of new digital tools.
• Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements, and internal SOPs.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

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.

Deadline

Apply before 1 May 2026. Applications are reviewed on an ongoing basis

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.