Are you ready to take the next step in your career? Novo Nordisk, a leading global healthcare company with a century-old legacy, is looking for a Senior Clinical Disclosure Professional to join their dynamic Clinical Reporting – GBS team in Bangalore, Karnataka. This role presents a unique opportunity for professionals passionate about clinical trial disclosure, quality assurance, and process improvements in clinical development.
About Novo Nordisk
With a focus on defeating serious chronic diseases, Novo Nordisk has made a significant impact on the lives of millions around the world. The company is renowned for its strong background in diabetes care and is continually expanding its reach and capabilities. For context, Novo Nordisk is currently recognized as one of the top 20 most valuable companies globally based on market capitalization. The organization takes pride in fostering a collaborative and innovative culture that empowers over 63,000 employees worldwide to realize their potential and contribute to life-changing healthcare solutions.
Key Responsibilities of a Senior Clinical Disclosure Professional
As a Senior Clinical Disclosure Professional, your primary responsibilities will include:
- Clinical Trial Disclosure Tasks: Execute clinical trial disclosure tasks effectively, ensuring compliance with relevant regulations and guidelines.
- Quality Control: Conduct thorough quality control of disclosure tasks to ensure high-quality deliverables.
- Skill Development: Drive skill enhancement initiatives within your team, focusing on the competencies necessary for quality deliverables.
- Process Improvements: Contribute to continuous process improvements and efficiency initiatives that enhance operational performance.
- Collaboration: Foster good collaboration and stakeholder engagement with global colleagues, promoting a team-oriented environment.
- Resource Planning: Support resource planning and collaborate with management to ensure optimal workload distribution.
- Process Expertise: Act as a process expert concerning disclosure deliverables, guiding the team in best practices and regulatory compliance.
Qualifications Required
To be considered for this role, you should possess the following qualifications:
- A PhD, MSc, MPharm, MD, BDS, or an equivalent degree.
- A minimum of 5 years of experience in evaluating and communicating clinical data, preferably within the pharmaceutical or Contract Research Organization (CRO) industry.
- Strong knowledge of clinical drug development processes, Good Clinical Practice (GCP), and pertinent regulatory requirements.
- Familiarity with regulatory submissions, including EudraCT and ClinicalTrials.gov registration and transparency requirements.
- A solid understanding of clinical trial methodology and experience in project-oriented, international work environments.
- Proficiency in utilizing IT tools tailored specifically for clinical trial disclosure and transparency.
Why Join the Clinical Reporting – GBS Team?
By becoming part of the Clinical Reporting – GBS team, you will play a crucial role in all clinical development activities from the initiation phase through to submission for regulatory approval. The team is responsible for delivering key competencies in Biostatistics, Programming, Data Management, Epidemiology, Real World Evidence, and Clinical Pharmacology. You will also benefit from a culture of knowledge sharing and training focused on optimizing trial plans and executions.
