Magnet.me  -  The smart network where hbo and wo students find their internship and first job.

The smart network where hbo and wo students find their internship and first job.

Manager, Clinical Disclosure Office

Posted 14 Jul 2024
Share:
Work experience
3 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
Dutch (Fluent)

Your career starts on Magnet.me

Create a profile and receive smart job recommendations based on your liked jobs.

Key Responsibilities:Participate in client trainings within Biomedical Research and Novartis Pharmaceuticals to drive quality and compliance and organizational alignment to changing disclosure requirements.Responsible for staying current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standardsIndependently represent Novartis to internal stakeholders. Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.s, Legal, and Business Development & Licensing.Participate in the maintenance of Standard Operating Procedures and preparations for external & internal audits.Apply a continuous improvement mind set ensuring best practices are shared continually driving to the most productive processesEssential RequirementsBachelor’s degree in a scientific discipline preferred.Minimum 3 years pharmaceutical industry experience with knowledge in disclosure including registration, maintenance, and results disclosure. (Experience with ClinicalTrials.gov, EudraCT and the Citeline Disclose tool (also known as PharmaCM) advantageous) knowledge of drug development, experience in writing protocols, experience in multiple clinical indications and/or therapy areas desiredProven development skills in a responsible position within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs or related areasAbility to successfully work within complex cross divisional matrix; previous experience leading multidisciplinary teams in matrix environmentStrong negotiation & conflict resolution skills; well organized, focused on results/compliance, strong planning, tracking, problem solving and decision making skillsProficiency in Good Clinical Practice, Regulatory Processes and clinical trial designsAbility to adapt to changing external environmentWhy Novartis?Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Other
Amsterdam
Active in 80 countries
300 employees
40% men - 60% women
Average age is 40 years