Job Description

Senior Medical Writer


Category: Clinical Development
Location: Bangalore, Karnataka, IN

Department - Clinical Reporting GBS

We are looking for a Senior Medical Writer in the Clinical Reporting unit based out of Global Business Service (GBS), Bangalore, India. Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

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 master/PhD in life sciences, pharmacology, medicine, etc. The team is full of commitment, passion, skills, and talent with broad knowledge of 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 the distribution of documents (CONNECT portal) and largely contributes toNN'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 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 able 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.

Contact


To submit your application, please upload your CV online (click on Apply and follow the instructions).


Deadline
20th July, 2024.

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.