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Senior regulatory document specialist

Cork
beBeeRegulatory
Document specialist
Posted: 29 August
Offer description

Job Overview

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The Global Scientific Communications team seeks a skilled Regulatory Document Writer to create high-quality regulatory documents.

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Key Responsibilities:

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* Document Development: Plan, write, and finalize regulatory documents; ensure data accuracy, clarity, and consistency.
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* Project Management: Develop timelines, manage risks, track progress, and maintain communication with stakeholders.
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* Scientific Expertise: Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
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* Collaboration & Coaching: Share best practices, provide guidance to colleagues, and contribute to process improvements.
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Requirements:

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* Bachelor's degree in life sciences, health, communications, or related field.
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* Advanced degree with research background.
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* Expertise in relevant therapeutic areas (e.g., oncology, neuroscience, immunology)
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* Experience with clinical development and regulatory submissions
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* Proven experience in regulatory or technical scientific writing
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* Strong communication, interpersonal, and project management skills
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* Proficiency with document management systems and standard software tools
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