Job title: Disclosure Medical Writer

Company: Novo Nordisk

Job description: Job description Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? The

Job description Does your motivation come from challenges and working in a dynamic environment Is your ambition to create visible results Are you enthusiastic about understanding the business and bringing attention to key business challenges Then we might have the right position for you. 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, Disclosure Medical Writers, 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 The daily work is performed in Clinical Reporting, Bangalore, in close collaboration with Clinical Reporting units in Denmark. As clinical research globally is in scope, contacts from all over NNs CMR organisation is in scope for trials registration and disclosure activities. Protocol registration and results disclosure of clinical trials to different registries eg: clinicaltrials.gov, EudraCT German Synopsis Other clinical trial disclosure and transparency related deliverables Redacted clinical documents for submissions as per different regulatory policies (eg: 0070 policy, 0043 policy, Health Canada), publication requirements (ICMJE) and company’s own policy Ensure timely, clear and proactive communication with stakeholders and colleagues for effective interactions and collaboration Qualifications The below knowledge, skills and experience will be required. PhD, MSc., M Pharm, MD, BDS, or equivalent 0-2 years of experience of evaluation and communication of data preferably 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 with clinical trial methodology Experience from working in a project orientated, international organization Good communication skills, fluent in written and spoken English Committed, persistent and accountable Able to manage variable workload Working at Novo Nordisk At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Kavita Bhuniwal [HIDDEN TEXT]. Deadline 1 July 2022 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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Location: Bangalore, Karnataka

Job date: Wed, 29 Jun 2022 22:56:18 GMT

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