Regulatory Writer

4 weeks ago

Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

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: our Novartis Network: Not the right role for you?
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