Are you known for being well-organized and structured with a good eye for details? Do you thrive with working independently, and do you assuming accountability of your delegated responsibilities? Then you might be the one we are looking for in our global research-organization – dedicated to providing first-class clinical research.
Here you will become a part of an environment driven by dedication and a positive mind-set. In NBCD you will be a part our highly motivated and close-knit team, fueled by a passion for science, innovation, and making a tangible difference in people's lives.
Working with us in NBCD, your impact will matter.
Your key roles and responsibilities
You will act as a member of the Regulatory Affairs & Safety team and report to the Associate Director of RA & Safety.
You will work in close collaboration with the Regulatory Affairs & Safety team, the Clinical Trial Management team and the Medical Affairs team, in addition to other frequent cross-functional collaborations in regular study activities.
Your job as Regulatory Affairs and Safety Associate will be highly varied and will amongst other responsibilities include the following:
- Ensure that the regulatory process for clinical trial submission is planned and executed including management of the Clinical Trial Application documentation for international Phase I-III clinical trials. You will handle document writing and collection, and coordinate submissions with multiple global stakeholders
- Coordination of interactions with national and international Regulatory Agencies and Independent Ethics Committees regarding new and existing clinical trials
- Prepare Safety Management Plans in collaboration with internal and external stakeholders, and process Adverse Events from Investigator sites, including handling, review and querying regarding Serious Adverse Events
- Responsible for complete and accurate safety data collection and registration of adverse events
- Completion and submission of expedited safety reports from our clinical trials to Competent Authorities and Independent Ethics Committees in accordance with local and global regulations
- Maintaining Pharmacovigilance and Regulatory dept. procedures and documentation in accordance with current laws and regulations
- Maintaining regulatory and safety parts of our Clinical Trial Master Files
- Engaging in correspondence with Sponsors, Contract Research Organizations and other Vendors, such as participation in recurrent sponsor and trial team meetings, as well as participation in internal and external audits.
Travel: Limited travel activity is to be expected.
Work location: Telefonvej 8D, 2860 Søborg, Danmark.
Are you up for the job?
Desired skills and experience
- You have an educational degree within health sciences
- You have experience with competent authority interactions, either regarding clinical trials or marketed products.
- Experience with GCP and Clinical Trials, eTMF and/or safety databases will be considered a plus
- You must have excellent communications skills and, as most our communication is in English, you must have fluent business English (oral and written) and basic medical writing skills.
Personal qualifications
- You are a responsible person who can work independently and assume accountability of your delegated responsibilities.
- You like to have things well-organized and structured.
- You have a good eye for details, as Regulatory Affairs and Pharmacovigilance relies on accurate reporting, documentation and filing.
- We expect you to be enthusiastic about innovative research and desire to learn new approaches and expand your core skill set.
- You have excellent collaboration skills and are able to cooperate and communicate with different professions and at different business levels.
- You prioritize making an effort for the working environment and the positive atmosphere among your colleagues - also in more busy periods.
Are we a perfect cultural fit?
Our commitment to you is encapsulated in our promise to every one of our employees saying ‘Trust in you - in your development and impact´.
This pledge extends uniformly across all entities within the Sanos Group organization, including NBCD, ensuring that you feel its effects from the very offset of your interaction.
If you are curious about whether you would thrive within the Sanos Group culture and the Sanos Way of Leading, reflect on whether you see yourself working within our principles:
- Take on - Responsibility is given, and we inspire you to take it.
- Try out - Explore diverse tasks and grow professionally.
- Team up - We don’t just work together; we thrive together.
Want to know more? Check out the people Voice of NBCD here.
What’s in it for you?
Here are some of the advantages of working with NBCD:
- Experience true trust and development - We are investing in your growth. Committing to you, we don't just offer opportunities. We trust you and give you the freedom to take ownership from day one. Experience rapid personal and career development with specialized training and continuous learning. We are committed to helping you reach your full potential while making a lasting impact on global healthcare and life sciences.
- Be part of a collegial community - Work in a place where collaboration is not just a word but a lifestyle. Our team culture is built on trust and teamwork, creating an environment where your ideas are valued, and you work side by side with supportive colleagues from diverse backgrounds. We are not just colleagues. We are a team.
- Enjoy flexible Work Arrangements - Flexible work hours and remote working options are available at positions where this is possible, enabling employees to balance their professional and personal lives more effectively.
- Pay attention to your physical and mental well-being - We recognize that a supportive environment is crucial for the overall performance and well-being of our employees. Therefore, we encourage open communication, brain breaks, using your workplace actively, as well as we offer extra support, to the extent that is needed and possible.
- Insurance benefits - As part of our salary framework and most important our commitment to our employee’s wellbeing, we offer health insurance to ensure you're protected should an unforeseen incident occur.
Ready to Make a Real Impact?
Discover a professional journey like no other. We are small enough to empower every individual yet powerful enough to drive transformative changes in the future of healthcare. We are committed to pushing the boundaries of the world of clinical trials, ultimately accelerating the availability of new treatments for patients in need.
Be a part of NBCD’s journey and help us pave the way for a healthier future.
Application
We only accept applications sent through the link. See below.
Introducing NBCD
Clinical Development Driven by Science
NBCD is a pivotal part within Sanos Group, that consists of around 200 employees. NBCD is the world leading CRO specialized in in osteoarthritis and other musculoskeletal diseases. NBCD provides top-tier scientific and clinical trial services to the biotech and pharmaceutical industries.
Innovative Solutions, Rapid Results
At NBCD, we believe in innovation. We understand that pioneering study designs and flawless execution are essential for developing life-changing medication quickly, intelligently, and efficiently.
Focused Expertise, Maximum Impact
Rather than spreading ourselves too thin, we concentrate our efforts on a few therapeutic areas and let the science drive our business, not the business drive the science. We leverage our deep-rooted research in connective tissue diseases like osteoarthritis and rheumatoid arthritis where we deliver unparalleled value.
Comprehensive Support, Every Step of the Way
From crafting study designs and writing protocols to managing trials and navigating regulatory affairs, NBCD covers it all under one roof. Our comprehensive approach ensures that every aspect of your clinical trial receives careful attention and expert handling.
Renowned Worldwide for Excellence
Operating at the forefront of international medication development, NBCD is renowned worldwide for our scientific prowess and operational excellence.
Read more here:
www.nbcd.com
www.sanos.com
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