Work as Associate Disclosure Medical Writer at Novo Nordisk

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.

Post : Associate Disclosure Medical Writer

Job Description
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
• You will be responsible for Performing Disclosure Medical Writing tasks
• 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

Candidate Profile
• 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

Additional Information
Qualification : PhD, MSc., M Pharm, MD, BDS
Location : Bangalore, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 25th June 2022