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Senior Clinical Disclosure Professional

5 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: M.Sc./ M.Pharm/ Life Sciences/ Phd Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Disclosure Professional

Location: Bangalore, India
Job Category: Clinical Development
Deadline: 24th February 2025


POSITION SUMMARY

Novo Nordisk is seeking a Senior Clinical Disclosure Professional to join our Clinical Reporting – GBS team. This position is ideal for someone with a strong background in clinical trial disclosure, process improvement, and ensuring high-quality deliverables. The role involves ensuring global collaboration and providing expertise in clinical trial disclosure tasks, while driving continuous process improvements and skill development within the team.


KEY RESPONSIBILITIES

  • Clinical Trial Disclosure: Perform disclosure tasks related to clinical trials, ensuring compliance with relevant regulatory requirements.
  • Quality Control: Conduct quality control activities to ensure accuracy and completeness of clinical trial disclosures.
  • Team Development: Drive skill development and enhance team competencies to ensure high-quality deliverables.
  • Process Improvement: Contribute to continuous process improvements and initiatives aimed at increasing efficiency and quality in disclosure tasks.
  • Collaboration: Foster good collaboration with global stakeholders and colleagues across functions.
  • Resourcing Support: Plan and support resourcing requirements in coordination with the immediate manager.
  • Process Expertise: Act as a process expert for clinical trial disclosure deliverables, providing guidance and expertise to the team.

QUALIFICATIONS

  • Education:
    • PhD, MSc, MPharm, MD, BDS, or equivalent degree in a relevant field.
  • Experience:
    • Minimum of 5 years of experience in evaluating and communicating clinical trial data, preferably in the pharmaceutical or CRO industry.
    • Strong knowledge of clinical drug development, Good Clinical Practice (GCP), and regulatory requirements.
    • Regulatory Familiarity: Understanding of EudraCT and CT.gov clinical trial registration and transparency requirements.
    • Experience in clinical trial methodology and working in a project-oriented, international organization.
    • Proficiency in using IT tools for clinical trial disclosure and transparency.

ABOUT THE DEPARTMENT

The Clinical Reporting – GBS team is responsible for managing all clinical development activities, from the initial planning of clinical trials to authority submission. The department provides essential resources and processes in Biostatistics, Clinical Reporting, Data Management, Epidemiology/Real World Evidence, and Clinical Pharmacology to support development projects. The team fosters a collaborative and innovative atmosphere to drive success in clinical trials and ensures process alignment across trial management and medical staff.


WORKING AT NOVO NORDISK

Novo Nordisk is a global healthcare leader with a legacy of over 100 years of driving change in the fight against serious chronic diseases. We are one of the 20 most valuable companies globally by market capitalization and are committed to expanding our reach, positively impacting the lives of over 40 million patients worldwide. Our success is driven by the collaboration of over 63,000 employees across the globe, with diverse perspectives and unique skills. At Novo Nordisk, we work toward something bigger than ourselves – making a life-changing impact together.


HOW TO APPLY

If you meet the qualifications and are excited about this opportunity, please submit your application through our online application tool.


Important Notice:
Please be aware of fraudulent job offers posing as Novo Nordisk recruitment. Novo Nordisk does not extend unsolicited offers or request personal information, equipment purchases, or funds during the recruitment process.


Novo Nordisk is committed to an inclusive recruitment process, ensuring equality of opportunity for all applicants. We embrace diversity and are dedicated to creating a culture that celebrates the diversity of our employees, patients, and the communities we serve. Together, we’re life changing.