Job title: Medical Writer
Company: Novo Nordisk
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Medical Writer
Category: Clinical Development and Medical
Location:
Bangalore, Karnataka, IN
We are looking for a 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 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) and Regulatory response documents (Q&A). You will have to communicate the clinical data in a clear and concise manner. You will contribute to knowledge sharing and 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.
Qualification
You are expected to have the below skills and knowledge:
Graduate (PhD, MSc., M Pharm, or equivalent)
2+ 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
Good communication skills
Works independently on smaller tasks
Strong analytical skills
Committed, persistent and accountable
Able to plan and manage variable workload
Working at Novo Nordisk
At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.
Contact
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Manager before applying.
Deadline
20 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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Tue, 21 Jun 2022 06:16:07 GMT
Apply for the job now!
