Corporate Responsibility Management Professional
1 month ago
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 UsNovartis 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.
- 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.
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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