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Novo Nordisk
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Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards
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97 Novo Nordisk Jobs
Senior Clinical Disclosure Professional
5-10 years
Bangalore / Bengaluru
1 vacancy
Senior Clinical Disclosure Professional
Novo Nordisk
posted 1y ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- 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.
Employment Type: Full Time, Permanent
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Top Novo Nordisk Professional Interview Questions
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What people at Novo Nordisk are saying
Professional salary at Novo Nordisk
reported by
10
employees
₹3.6
L/yr - ₹6
L/yr
53%
less
than the average Professional Salary in India
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What Novo Nordisk employees are saying about work life
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Flexible timing
Monday to Friday
No travel
Day Shift
Novo Nordisk Benefits
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