Novo Nordisk Hiring Senior Medical Writer
About the job
We are looking for a Senior Medical Writer in the Clinical Reporting unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.
About The Department
The Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. 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. The team is full of commitment, passion, skills, and talent with broad knowledge on different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. 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 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. 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.
You should ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. You will communicate across the time zones and in different professional environments. This job requires good communication and analytical skills. 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.
You are expected to have the below skills and knowledge:
- Graduate (PhD, MSc., M Pharm, or equivalent)
- 5+ years of experience as medical writer or other relevant work experience
- 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
- Recognizes problems; may need advice to solve
- Prioritizes own tasks but may need to seek advice
- Kindly note that job applicants with experience in safety documents or journal writing will not be considered as relevant.