Corporate Responsibility Management Professional

1 month ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
Job Summary

We are seeking an experienced Corporate Responsibility Manager to join our team at Novartis. As a key member of our organization, you will be responsible for the delivery and oversight of CSR appendices authoring, formatting, compilation, and publishing required for regulatory submissions.

About Us

Novartis is a leading global healthcare company committed to discovering, developing, and commercializing innovative medicines and treatments that improve patients' lives. We offer a dynamic and inclusive work environment that fosters collaboration, innovation, and growth opportunities.

Responsibilities
  • Efficiently manage and coordinate CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs.
  • Implement submission document readiness management strategy for clinical documents and templates in collaboration with CDGM groups, business, and IT Functions.
  • Develop and maintain submission readiness processes, driving initiatives to enhance business and technical aspects of submission readiness activities.
  • Identify and communicate processing risks/trends/patterns related to CSR appendices and implement remediations in collaboration with stakeholders.
  • Serve as Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools for CSR appendices oversight activities.
Requirements
  • Bachelor's degree in life sciences, healthcare, pharmacy, or information management.
  • Relevant industry experience and thorough knowledge of clinical document management processes.
  • Advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice, Data integrity, ICH eCTD, and FDA Portable Document formatting specifications).
  • Experience authoring, compiling, and formatting CSR appendices according to ICH E3.
  • 3-5 years in clinical development, clinical operations, or similar business area.
  • Excellent understanding of document management systems and technical processes.
Benefits

As a Corporate Responsibility Manager at Novartis, you can expect a competitive salary of £60,000 - £80,000 per annum, depending on location and experience. Our comprehensive benefits package includes a generous pension scheme, flexible working hours, and professional development opportunities. We also offer a hybrid remote work arrangement, allowing you to balance your work-life balance.

In addition to the above benefits, you will have access to our state-of-the-art facilities, including a fitness center, cafeteria, and childcare services. We prioritize diversity, equity, and inclusion, creating a workplace where everyone feels valued and respected.



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