Only 24h Left Regulatory Writer

4 weeks ago

Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time
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
#J-18808-Ljbffr

  • 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, IrelandNovartis is unable to offer relocation...

  • Regulatory Writer

    3 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, IrelandNovartis is unable to offer relocation...

  • Regulatory Writer

    3 weeks ago

    Dublin, Dublin City, Ireland Healthcare Businesswomen'S Association Full time

    Job Description SummaryTo 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, IrelandNovartis is...

  • Only 24h Left Software Engineering, Sr Engineer

    3 weeks ago

    Dublin, Dublin City, Ireland Synopsys, Inc. Full time

    We Are:At Synopsys, we drive the innovations that shape the way we live and connect. Our technology is central to the Era of Pervasive Intelligence, from self-driving cars to learning machines. We lead in chip design, verification, and IP integration, empowering the creation of high-performance silicon chips and software content. Join us to transform the...

  • Technical Writer

    3 weeks ago

    Dublin, Dublin City, Ireland Oliver James Full time

    Join to apply for the Technical Writer role at Oliver James1 day ago Be among the first 25 applicantsJoin to apply for the Technical Writer role at Oliver JamesGet AI-powered advice on this job and more exclusive features.This range is provided by Oliver James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn...

  • Only 24h Left) Consultant ENT

    2 weeks ago

    Dublin, Dublin City, Ireland Hive Healthcare Full time

    Social network you want to login/join with:col-narrow-leftClient:Location:Dublin, IrelandJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:40535dbae11fJob Views:4Posted:18.06.2025Expiry Date:02.08.2025col-wideJob Description:Join Our Team as a Consultant ENT at Hive HealthcareHive Healthcare is seeking a skilled and dedicated...

  • Only 24h Left) Knowledge Lawyer

    2 weeks ago

    Dublin, Dublin City, Ireland Keane McDonald Full time

    Knowledge Lawyer (PSL) – Construction Law - DublinA top law firm in Dublin has a superb new opportunity for an experienced Construction Lawyer to join their market leading Knowledge Management Division as Knowledge Lawyer (PSL). The Knowledge Lawyer will support their Construction and Infrastructure Practice.In this role, you will work closely with the...

  • Only 24h Left: Go To Market

    3 weeks ago

    Dublin, Dublin City, Ireland SSE plc Full time

    Base Location:Dublin (hybrid working pattern)Salary: €65,300 - €82,000 + performance-related bonus + a range of benefits to support your finances, wellbeing and family.Working Pattern: Permanent | Full Time | Flexible First options availableThe roleYou will own the end-to-end Go-To-Market (GTM) delivery of product, proposition, pricing, and regulatory...

  • Only 24h Left Service Manager

    4 weeks ago

    Dublin, Dublin City, Ireland St. Michaels House & Services Full time

    Service Manager for Adult Services One Year Fixed Term Contract 1 Full-time (37.5 hours/week) About us: St. Michaels House provides a comprehensive range of services and supports to men, women, and children with disabilities and their families in 170 locations in the greater Dublin area. We support 1,936 individuals, positively impacting thousands of family...

  • Only 24h Left Principal Device Technical Regulatory Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Viatris Inc. Full time

    Principal Device Technical Regulatory Specialist page is loadedPrincipal Device Technical Regulatory SpecialistApply locations Northern Cross, Dublin, Ireland time type Full time posted on Posted Today job requisition id R5660652 McDermott Laboratories LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely...