Job Description

Job description Department - Clinical Reporting Does your motivation come from challenges and working in a dynamic environment Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential Do you have a can-do attitude with continuous improvement as one of your career objectives Then we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department Clinical Reporting - GBS is an integral part of the Global Clinical Reporting community, since its inception in 2011. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Clinical Disclosure Professionals, Publishers and Document Controllers with Masters/PhD in life sciences, pharmacology, medicine, etc. Apart from writing and publishing regulatory documents, the team is also responsible for distribution of documents (CONNECT portal) and largely contributes to NN\'s regulatory commitments by being involved in public disclosure activities. The Position As a Team Lead - Clinical Transparency, you lead and drive deliverables ensuring Novo Nordisk compliance with Disclosure Requirements. Manage the teams to meet the department and organization\'s business goals. You will perform Clinical Transparency tasks including preparation/review and timely submission of protocol registration and results disclosure of clinical trials to different registries example clinicaltrials.gov, EudraCT, German Synopsis and other clinical trial disclosure and transparency related deliverables. Contribute to ongoing process improvements and efficiency initiatives in disclosure and registration activities internally, in cross-functional areas and globally. You are entrusted to fulfil the following responsibilities: Responsible to Perform Clinical Transparency deliverables and People Management. Ensure effective coaching and mentoring of team members to enhance performance and sup-port individual development Plan resources for all deliverables from the team and support manager in ensuring optimal and flexible use of resources. Ensure effective collaboration with stakeholders and colleagues globally . Ensure continuous improvement and processes are efficient, scalable, and effective. Maintain up-to-date knowledge on global regulatory requirements and other policies related to clinical trial disclosure and transparency. Qualification PhD, MSc., M Pharm, MD, BDS, or equivalent. Above 5 years of experience of evaluation and communication of data preferably from the pharmaceutical /CRO industry. Experience with clinical drug development, GCP and relevant regulatory requirements in relation to clinical trials registration and transparency, especially the EudraCT and CT.gov related requirements. Experience in leadership is preferred including people and project management roles Experience with clinical trial methodology. Excellent understanding of clinical development and regulatory processes and requirements. Excellent communication and presentation skills Good mentoring and training skills. Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We\'re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we\'re all here - to ensure that people can lead a life independent of chronic disease. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Apply Now! Deadline 24th, July 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

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