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 : Senior Medical Writer
Job Description
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 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 in a clear and concise manner.
• Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally.
• You will contribute to process improvements, knowledge sharing, skill building, and mentor and train other medical writers as needed. You will have to maintain good relationship with the stakeholders and colleagues.
• Responsible in order to meet timelines, the medical writer must be good at planning own work and 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 travelling abroad to attend meetings in HQ and CMRs, and conference and courses world-wide, will be the part of the job.
Candidate Profile
• Graduate (PhD, MSc., M Pharm, or equivalent).
• 5+ years of experience as 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 from the pharmaceutical /CRO industry.
• Strong understanding of external requirements related to regulatory documents.
• Works independently on smaller tasks.
• Strong analytical skills.
• Committed, persistent and accountable.
• Able to manage variable workload.
• Able to handle numerous tasks simultaneously.
• Prioritizes own tasks but may need to seek advice.
• Requires good communication and analytical skills.
Additional Information
Qualification : Graduate (PhD, MSc., M Pharm, or equivalent)
Experience : 5+ years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 31st August, 2023
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