Senior medical writer

Found in: Talent IN C2 - 3 weeks ago

Bengaluru, India Novo Nordisk Full time

The position

The key responsibilities in this position will be to perform medical writing tasks for trial and/or non-trial activities within clinical reporting including but not limited to the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Layperson Summary (LPS), Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews. The tasks, to a large extent, will have to be performed independently. You will have to communicate the clinical data clearly and concisely. Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. You will contribute to process improvements, knowledge sharing, and skill building, and mentor and train other medical writers as needed. You will have to maintain good relationships with the stakeholders and colleagues. Responsible for meeting timelines, the medical writer must be good at planning their work be proactive when problems arise, and seek help and advice from relevant people within GBS as well as within HQ. You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. Frequent traveling abroad to attend meetings in HQ and CMRs, and conferences and courses worldwide, will be part of the job. Qualification You are expected to have the following skills and knowledge: Graduate (PhD, MSc., M Pharm, or equivalent). 5+ years of experience as a medical writer or other relevant work experience. Experience in CSR, protocol, IB, informed consent, and clinical summaries and clinical overviews. Experience working within a global setting. Experience in the pharmaceutical /CRO industry. Strong understanding of external requirements related to regulatory documents. Strong analytical skills. , committed, persistent, and accountable. Able to manage variable workload and a ble to handle numerous tasks simultaneously. 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.

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