Associate Disclosure Medical Writer

2 months ago

Bengaluru, India Novo Nordisk Full time

**Department - Clinical Reporting**

**About the department**

Clinical Reporting - GBS is an integral part of the Global Clinical Reporting community, since its inception in 2011. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Clinical Disclosure Professionals, Publishers and Document Controllers with Masters/PhD in life sciences, pharmacology, medicine, etc. 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 Associate Clinical Disclosure Professional you will perform Clinical Transparency tasks including preparation/review and timely submission of protocol registration and results disclosure of clinical trials to different registries example clinicaltrials.gov, EudraCT, German Synopsis and other clinical trial disclosure and transparency related deliverables Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas including tools and technology and knowledge on global regulatory requirements and other policies related to clinical trial disclosure and transparency. Contribute to ongoing process improvements and efficiency initiatives in disclosure and registration activities internally, in cross-functional areas and globally. You are entrusted to fulfil the following responsibilities:

- Responsible to Perform clinical trial disclosure tasks - including preparation/review and timely submission**.**:

- Redacted clinical documents for submissions as per different regulatory policies (e g: 0070 policy, 0043 policy, Health Canada), publication requirements (ICMJE) and company’s own policy
- Ensure Quality control of disclosure tasks include QC of redacted CTRs and results tables/Data Sets/synopses to clinical trial registries world-wide.
- Ensuring effective collaboration with stakeholders and colleagues globally**. **Ensuring continuous improvement and processes are efficient, scalable, and effective.
- Maintain up-to-date knowledge on global regulatory requirements and other policies related to clinical trial disclosure and transparency.

**Qualification**
- PhD, MSc., M Pharm, MD, BDS, or equivalent.
- 2+ years of experience of evaluation and communication of data preferably from the pharmaceutical /CRO industry
- Experience with clinical drug development, GCP and relevant regulatory requirements in relation to clinical trials registration and transparency, especially the EudraCT and CT.gov related requirements
- Experience with clinical trial methodology
- Experience from working in a project orientated, international organization.
- Works independently on smaller tasks
- Strong analytical skills
- Committed, persistent and accountable
- Able to manage variable workload

**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**

**Deadline**

24th, July 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.

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