Senior Scientific/Regulatory Writer
2 weeks ago
-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.Major accountabilities: Core member of clinical Trial Team/participate in safety Management Team -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.Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)Key performance indicators: Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to Novartis policy and guidelinesMinimum Requirements: Work Experience: Functional Breadth.Cross Cultural Experience.Collaborating across boundaries.Operations Management and Execution.Skills: Clinical Research.Clinical Trials.Detail Oriented.Medical Writing.Regulatory Compliance.Safety.Languages :English.
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Senior Technical Writer
4 months ago
Dublin, Ireland ChannelEngine Full timeAt ChannelEngine, our clients rely on clear, accurate, and practical guides to fully leverage our platform's capabilities, ensuring seamless integration and maximisation of their online sales channels. This is where our team of talented technical writers comes in! They provide well-structured and easy-to-understand documentation, which is critical in helping...
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Senior Technical Writer
2 days ago
Dublin, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
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Manager, Scientific Affairs
3 months ago
Dublin, Ireland Perrigo Full timeDescription Overview This role focuses on substantiation and management of safety and health benefit claims for new and established brands and products within the CSCI OTC organisation. The Scientific Affairs Manager leads on proving efficacy to drive competitive claims throughout product lifecycle and partners with Product Developers to develop superior...
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Medical Writing Manager
3 months ago
Dublin, Ireland Gilead Sciences Full timeJob Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...
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Manager, Scientific Affairs
3 months ago
Dublin, Ireland Perrigo Full timePerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not...
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Manager, Scientific Affairs
1 week ago
Dublin, Ireland Perrigo Full timeAt Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the...
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Senior Regulatory Affairs Assistant
2 months ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
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Senior Regulatory Affairs Manager
2 weeks ago
Dublin, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...
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Medical Writing Manager
3 months ago
Dublin, Ireland Gilead Sciences Ireland UC Full timeDescription Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening...
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Director, Global Regulatory Affairs, Pediatrics
4 months ago
Dublin, Ireland Gilead Sciences Full timeJob Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...
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Director, Global Regulatory Affairs, Pediatrics
4 months ago
Dublin, Ireland Gilead Sciences Ireland UC Full timeDescription Director, Global Regulatory Affairs, Pediatrics Dublin, Ireland At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower...
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REACH Regulatory Project Manager
4 months ago
Dublin, Ireland Exponent Full timeOur Opportunity We are currently seeking a REACH Regulatory Project Manager to operate within our Industrial Chemicals group for our Chemical Regulation and Food Safety Practice to provide leadership and support project teams working on regulatory submissions for the registration of industrial chemicals in the EU and UK. The role could be based from...
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Dublin, Ireland Allied Irish Bank Full timeRole Title: Senior Regulatory Analyst, Prudential Advisory, Regulatory ComplianceLocation: Dublin / Hybrid This role is being offered on a permanent basis. Summary of role:Group Compliance is an independent, second line of defence function established within the Risk function. An opportunity now exists for a Senior Regulatory Analyst, Level 3, which will...
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Manager, Regulatory Submission Project Management
3 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeSUMMARY: The Manager, Regulatory Submission Project Management will be responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to postmarketing. The incumbent will report to the Sr Mgr Regulatory Submission Project Management and serve as the Reg PM lead for assigned therapeutic area (TA) and...
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Senior Manager, Regulatory Intelligence
2 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeThis role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical...
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Regulatory Affairs Officer
2 months ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
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Senior Regulatory Energy Lawyer
2 months ago
Dublin, Ireland Michael Page Legal Full timeVaried complex regulatory work for a regulatory energy specialist lawyer. Power, Infrastructure & Energy Projects - Decommissioning, Regulatory & Risk.Client Details Our client is the owner and operator of multiple power generation assets in the UK, Ireland and Globally. DescriptionThe organisation's team includes commercial, technical, financial and...
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Finance Prudential Regulatory Senior Associate
3 months ago
Dublin, Ireland Davy Group Full timeAbout us From day one, you’ll notice there is something special about working at Davy. Our success is built on nearly 100 years of forging strong relationships with our clients and developing the careers of Ireland’s future business leaders. Established in 1926, the Davy Group sits at the heart of wealth and capital in Ireland, providing a broad range...
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Manager, Regulatory Intelligence
2 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeRegeneron is seeking a Manager to join the Regulatory Intelligence Group! In this role, a typical day might include: The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as...
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Senior Business Analyst
3 weeks ago
Dublin, Ireland NTT DATA Services Full timeNTT DATA Services strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now Summary We are seeking a knowledgeable and experienced Senior Business Analyst with extensive IT/Consulting experience in the financial...