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Regulatory Writer
4 weeks ago
Job Description Summary
To write, review and / or 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.
Job Description
#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
To 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 for outsourced Narrative projects.
Coordinate other outsourced activities in
RWS.
Be a Core member of Clinical Trial Team (CTT) / participate in Safety Management Team
(SMT).
Actively participate in planning of data analyses and presentation used in
CSRs.
Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
Desirable requirements
Excellent communication skills (written, verbal,
presentations)
Very good understanding of biostatistics
principles.
Ability to prioritize and manage multiple demands and
projects.
Ability to define and solve complex problems
Proven track record in matrix
environment
Experience in contributing to global, cross-functional
projects.
Essential requirements
Minimum university life science degree or equivalent is required.
Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting
requirements).
Knowledge of process for and some experience in global registering of drugs (simple submissions).
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Regulatory Compliance, Safety
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