Regulatory Affairs & Safety AssociateYou will act as a key member of the Regulatory Affairs & Safety team and report to the Associate Director of RA & Safety. You will work in close collaboration with the Associate Director, other members of the Regulatory Affairs & Safety team, the Medical Coding team, the Clinical Trial Management team as well as the Medical Affairs team, in addition to other frequent cross functional participation in regular study activities.
NBCD A/S is an international drug development organization. We believe that innovative study designs and execution are key aspects in developing new drugs smarter, better, and faster.
We provide biotech and pharmaceutical industry with scientific and clinical trial services. NBCD perform all aspects of clinical trials including trial design, protocol writing, medical monitoring, data management, regulatory affairs, pharmacovigilance, and trial management.
We focus our efforts on innovative clinical trials in few therapeutic areas, so that we can provide additional value based on our research-legacy in connective tissue-diseases such as osteoarthritis and rheumatoid arthritis. We operate at the forefront of international drug development research and are internationally renowned for scientific and operational expertise.
NBCD is a part of the Sanos Group, consisting of independent business units encompassing Sanos Clinic, Sanos Supply and Studies&Me.
At present the Group includes around 100 employees – and growing consistently.
All business units in the Sanos Group are dedicated to providing first-class clinical research, aiming to keep improving and develop how we conduct innovative clinical trials.
As our organization is growing, we are now looking for our new colleague.
About the job
Your job as Regulatory Affairs and Safety Associate will be highly varied and will amongst other responsibilities include the following:
- Manage Clinical Trial Application documentation for international Phase I-III clinical trials, where you will handle the writing, collection and coordination with multiple global stakeholders
- Coordination of interactions with national and international Regulatory Agencies and Independent Ethics Committees regarding new and existing clinical trials
- Processing 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.
You thrive with broad responsibilities – as we rely on our agility and efficiency. We strongly believe in empowerment and giving our employees freedom to operate and to innovate.
Advantages of working with NBCD
You will play an important role in a dynamic research-organization with world-wide reach in an environment driven by science and good ideas, where you can truly make a difference and see your own ideas come to life.
It is possible for you to broaden your skillset, being introduced to all clinical and non-clinical pre-market aspects of drug development in one place.
We invest in developing and promoting our staff and you will be given great opportunities for personal and professional development – we are a flat, tight organization in which your successes will not go unnoticed.
You get the opportunity to contribute to our academic publication activities and authoring impactful new papers - NBCD publishes several peer-reviewed articles each year in highly regarded medical journals.
Desired skills and experience
- You have an educational degree within health sciences
- Experience with GCP and Clinical Trials will be considered a plus
- Experience with regulatory affairs concerning medicinal products, electronic trial master file systems, safety databases etc. will be considered a plus.
- 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 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.
Do you want to join us?
To apply please send your CV and a letter of motivation to firstname.lastname@example.org - we are looking forward to hearing from you!
For further information about the role contact, Associate Director, Bodil Vibe Rønnow Foxby at email@example.com.
We are conducting interviews on a regular basis and will close the position when we find the right candidate.
We might use assessments as a part of the recruitment process.
We encourage all qualified candidates to apply for the position – regardless of ethnic background, gender, sexual orientation, disability, religion or age.
We value your data and take care to protect it. Please see more information regarding privacy for job applicants here
Work location: Our new headquaters at Telefonvej 8, 2860 Søborg (from December 2022)
At NBCD we focus our efforts on innovative clinical trials in few therapeutic areas, where we can provide additional value with our scientific expertise addressing unmet medical needs.
As a part of the Sanos Group you will join a global company – dedicated to providing first-class clinical research.