Job Description

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Start-up Regulatory Specialist

Category: Clinical Development

Location:

Johannesburg, Gauteng, ZA

Are you a person who is good at managing professional relationships? Do you need to have things in order, and attention to detail is one of your qualities? If you are ready to make a difference in our clinical department, you might be our new Start-up Regulatory Specialist. Apply today and drive the change with us at Novo Nordisk.

This role is based in Johannesburg, South Africa and directly reports to CDC Clinical Research Manager.

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.

About The Department

In Novo Nordisk Regulatory Affairs we are committed to being one step ahead for our patients and for our business. The scope of our work spans across the entire research and development value chain. And therefore, we feel we are like the glue that connects research to commercial access. That goes from the earliest stages of drug development and research, and all the way to securing and maintaining commercial licenses for our life-changing treatments.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we're life changing.

Contact

To submit your application, please upload your CV in English (click on Apply and follow the instructions). Please note that we are reviewing applications on an ongoing basis and that the position will be filled as soon as a successful candidate is found.

Deadline

04.01.24

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

Novo Nordisk