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Medical Writer

3 weeks ago

Bengaluru Karnataka, India Novo Nordisk Full time

Medical Writer

**Category**:Clinical Development

**Location**:Bangalore, Karnataka, IN

**Department -**Clinical Reporting Unit

**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 fulfil 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, Pharm D, 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.

**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.

**Working at Novo Nordisk**
- Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.

**Contact**

**Deadline**

**Disclaimer**
- It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process._
- 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 theref