Job Description

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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. Doesyour motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where closecollaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement asone of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in aninternational 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 Reportingcommunity in a short span of 6-7 years, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled MedicalWriters, 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 requirementsfor submissions. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications. We useour scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing andpublishing regulatory documents, the team is also responsible for 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 clinicalreporting 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 concisemanner.

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 asneeded. 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 whenproblems 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 beimproved.

Frequent travelling abroad to attend meetings in HQ and CMRs, and conference and courses world-wide, will be the part ofthe job.

Qualification

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 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.

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 basisof ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, lifeis 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

30th Dec, 2023.

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.

Novo Nordisk