Regulatory Affairs and Safety Associate for NBCD A/S
- a Science-Driven Drug Development Organization.
NBCD A/S is an international drug development organization. We believe that personalized medicine, innovation in study design and execution are the key aspects in developing new drugs smarter, better and faster.
NBCD, formerly Nordic Bioscience Clinical Development, was established in 2006, and provides scientific and clinical trial services to the biotech and pharmaceutical industry in addition to developing own drug candidates. The portfolio of both sponsor programs and full service CRO trials provides unique insight to the entire clinical trial industry. NBCD currently consists of approximately 30 employees based in Herlev, Denmark in addition to 5 Clinical Research Associates based throughout Europe and Asia. We perform all aspects of clinical trials such as 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, where we can provide additional value, based on our research-legacy in connective tissue-diseases such as osteoarthritis and rheumatoid arthritis. NBCD is a small, but growing operation, which means we rely on our agility and efficiency. Every team member has broad responsibilities and we strongly believe in empowerment and giving our employees freedom to operate and to innovate.
As a result of our continued growth, we are now looking for a colleague to join our Regulatory Affairs and Safety department in Herlev.
Your job as Regulatory Affairs and Safety Associate will be highly varied and will amongst other responsibilities include the following:
- Collecting and coordinating Clinical Trial Application documentation
- Assisting in interactions with Regulatory Agencies and Independent Ethics Committees regarding new and existing clinical trials
- Processing Adverse Events from Investigator sites, including handling and issuing queries regarding Serious Adverse Events
- Submission of expedited reports from our clinical trials to Competent Authorities and Independent Ethics Committees in accordance with local and global regulations
- Responsible for complete and accurate safety data collection and registration of adverse events
- Maintaining Pharmacovigilance and Regulatory dept. documentation in accordance with current laws and regulations
- Maintaining Clinical Trial Master Files
- Engaging in correspondence with Sponsors, Contract Research Organizations and other Vendors
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.
NBCD is offering
- An important role in a highly dynamic research-organization with world-wide reach
- An environment driven by science and good ideas, where you can make a difference
- Great opportunities for personal development
- Great possibilities to work with all clinical and non-clinical pre-market aspects of drug development in one place
- A flat, tight organization, in which your successes will not go unnoticed.
For further information please contact RA and PV Manager Bodil Foxby (firstname.lastname@example.org) or +45 7370 7908
To apply please send a letter of motivation and a CV to email@example.com