Clinical disclosure specialist
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Are you an expert in clinical disclosure regulations and can you drive the implementation and ensure compliance? Then continue reading!
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. During our efforts to help even more patients we aim for transparency about our clinical data. Also, it is of utmost importance that we comply with current legislations and authority requirements. For this, we need support to our clinical disclosure group.
The job
The overall objective of this job is to provide the basis for ensuring compliance with clinical disclosure regulations and LEO Pharma’s policy of transparency for clinical data and patient centricity. Tasks will include:
- Subject matter expert with responsibility for planning, advising on, coordinating, and handling public disclosure of clinical trial information.
- Monitor and evaluate the clinical trial disclosure landscape, including regulatory requirements and industry trends.
- Develop, pilot, implement, update, and maintain procedures to ensure compliance with regulations and other commitments for clinical data transparency.
Your qualifications
- University degree in health or biological science (MD, MSc, MSc Pharm or equivalent).
- Thorough knowledge of clinical development, GCP, scientific research methods, and applicable regulatory guidelines. Understanding of clinical statistics.
- Strong IT flair – documented through previous experience, either professional or private.
- Prior experience with clinical disclosure will be an advantage.
You have a compliance mindset, but you are able to see different solutions to a problem. You have excellent collaboration skills, and you are patient and enjoy mentoring others on your area of expertise. You thrive in an environment of constant change, and you believe in continuous improvement. Finally, you have a healthy sense of need-to versus nice-to, and you understand that improvements are developed in steps without necessarily reaching the perfect process in the first step.
Your new team
Your closest colleagues will be 2-3 other disclosure specialists. You will work closely together, solving the same types of tasks for different projects, and sharing the responsibility for various processes between you. The disclosure specialists are organized in Medical Communications, which also includes 2 teams of medical writers, with whom you will be closely collaborating. Other important collaborators are Biostatistics, Medical Experts, Medical Affairs, Patents, Legal, IT, Regulatory Affairs, and Clinical Operations.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Bente Riis, Interim Head of Clinical Disclosure, at +45 2249 5017, or Kreesten Meldgaard Madsen, Senior Director, Medical Department, at +45 6080 1100.
. The deadline is Sunday 01 August 2021.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 30.6.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
- Søndag den 01. august 2021
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