Job Description

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Medical Writer

Category: Clinical Development

Location:

Bangalore, Karnataka, IN

Department - Clinical Reporting Unit

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 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 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

As a Medical Writer you will ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Furthermore, 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, you 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 Head Quarters (HQ). Additionally, you will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. You are entrusted to fulfill the following responsibilities:

• You will be performing 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.

Qualification

You are expected to have the below skills and knowledge:

• Graduate (PhD, MSc., M Pharm, or equivalent).
• 4+ 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 don\'t wait for change. We drive it. We\'re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales- we\'re all working to move the needle on patient care.

Contact

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool. Internal candidates are kindly requested to inform their line Manager before applying. We don\'t take applications via direct mail.

Deadline

Apply before 6th Jan, 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