To write, review, and manage the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation-related consultancy to other line functions.
About the Role
#LI-Hybrid (3 days per week on-site)
Location: Dublin, Ireland
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
The Regulatory Medical Writer will be responsible for writing and reviewing high-quality clinical and safety documentation for submission to regulatory authorities.
Major responsibilities
* Author and review high-quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
* Lead outsourced Narrative projects and coordinate other outsourced activities in RWS.
* Be a core member of the Clinical Trial Team (CTT) and participate in Safety Management Team (SMT).
* Participate in planning data analyses and presentation used in CSRs.
* Act as a documentation consultant in CTTs and SMTs to ensure compliance with internal standards and external regulatory guidelines.
* May act as Program Writer to ensure adequate medical writing resources and document consistency.
* Maintain a good understanding of biostatistics principles.
* Prioritize and manage multiple demands and projects effectively.
* Define and solve complex problems.
* Proven track record in a matrix environment.
* Experience contributing to global, cross-functional projects.
* Minimum university degree in life sciences or equivalent; an advanced degree is desirable.
* Experience in medical writing or relevant pharma industry experience with scientific and regulatory knowledge.
* Good knowledge of global regulatory environment and processes, including key regulatory bodies and safety reporting requirements.
* Some experience in global drug registration submissions.
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an inclusive work environment and diverse teams that reflect the patients and communities we serve.
Why Novartis: Helping people with disease and their families requires more than science. It requires a community of passionate, collaborative individuals. Join us to create a brighter future: https://www.novartis.com/about/strategy/people-and-culture
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IE02 (FCRS = IE002) Novartis Ireland Ltd
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