Job Description

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Senior Clinical Disclosure Professional

Category: Clinical Development

Location:

Bangalore, Karnataka, IN

Senior Clinical Disclosure Professional

Department - Clinical Transparency

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

Clinical Reporting - Bangalore 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, Disclosure Medical Writers, 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 Senior Clinical Disclosure Professional you will perform tasks including preparation 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:

Perform clinical trial disclosure tasks - including preparation and timely submission.

• Responsible for Protocol registration and results disclosure of clinical trials to different registries eg: clinicaltrials.gov, EudraCT, etc. German Synopsis and other clinical trial disclosure and transparency related deliverables.
• Redacted clinical documents for submissions as per different regulatory policies (eg: 0070 policy, 0043 policy, Health Canada, EU CTR), publication requirements (ICMJE) and company\'s own policy and various other regulatory requirements.
• Ensure and drive skill development and enhancement for securing quality deliverables and right level of competencies in the team.
• Ensure Justification tables and anonymization reports for redacted document\'s submission.
• Quality control of disclosure tasks include QC of redacted CTRs and results tables/Data Sets/synopses to clinical trial registries world-wide. Maintain up-to-date knowledge on global regulatory requirements and other policies related to clinical trial disclosure and transparency.

Qualifications

• PhD, MSc., M Pharm, MD, BDS, or equivalent.
• \xe2\x89\xa5 5 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.
• Experience in working on IT tools in disclosure and transparency area.
• Experience from working in a project orientated, international organization.
• Works independently and drives projects.
• Strong analytical skills.
• Committed, persistent and accountable.
• Able to manage variable workload.

Working at Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

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

Deadline

20th March 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.

Novo Nordisk