
Pivotal Regulatory Documentation Specialist
2 days ago
Regulatory Writer
">You will play a pivotal role in producing high-quality clinical and safety documentation for submission to regulatory authorities.
Key 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.">
- Be a core member of the Clinical Trial Team (CTT) and participate in Safety Management Team (SMT).">
The ideal candidate will have a strong understanding of biostatistics principles, excellent communication skills, and the ability to prioritize and manage multiple demands effectively.
Requirements:">- ">
- 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.">
-
Senior Regulatory Document Specialist
4 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €55,000 - €85,000As a clinical documentation specialist, you will be responsible for creating high-quality documentation that meets regulatory requirements. Your work will support marketing applications and provide consultancy to other functions.About the RoleYou will lead outsourced projects, coordinate other outsourced activities, and participate in safety management...
-
Chief Document Specialist
5 days ago
Dublin, Dublin City, Ireland beBeeDocumentation Full time €70,401 - €91,421Regulatory WriterThis role plays a pivotal part in the organization, responsible for creating and reviewing high-quality clinical and safety documentation to be submitted to regulatory authorities.
-
Senior Regulatory Compliance Specialist
3 days ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €60,000 - €80,000Role Overview:As a Senior Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance with relevant regulations and standards for Class III implantable devices.This position presents an exciting opportunity to contribute to the development of a novel cardiovascular device at an early-stage medical device company.Develop and maintain...
-
Clinical Documentation Specialist
2 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €96,000 - €103,500As a seasoned regulatory writer, you will play a pivotal role in crafting high-quality clinical and safety documentation that meets the stringent requirements of regulatory authorities worldwide.About the RoleThe ideal candidate will be responsible for authoring and reviewing complex clinical and safety documents, including non-registration Clinical Study...
-
Documentation Specialist
4 days ago
Dublin, Dublin City, Ireland beBeeTechnical Full time €60,000 - €80,000Documentation SpecialistThis is a challenging opportunity for an experienced Documentation Specialist to join our team in a hybrid role.The successful candidate will be responsible for:Developing, implementing and maintaining documentation procedures in line with site requirements.Serving as document owner.Preparing and delivering training materials and...
-
Document Writer
2 days ago
Dublin, Dublin City, Ireland beBeeRegulatoryWriter Full time €60,000 - €80,000Job SummaryWe are seeking a skilled writer to create high-quality clinical and safety documentation for regulatory submissions. The ideal candidate will have experience in medical writing, regulatory affairs, and excellent communication skills.This role requires strong knowledge of the global regulatory environment, including key documents, approval...
-
Technical Documentation Specialist
6 days ago
Dublin, Dublin City, Ireland beBeeDocumentation Full time €50,000 - €75,000Job Title: Technical Documentation SpecialistWe are seeking a highly skilled Technical Documentation Specialist to join our team. As a key member of our supply chain operations, you will be responsible for creating and maintaining detailed documentation for global supply chain processes.Key Responsibilities:Develop, write, and maintain detailed documentation...
-
Pivotal Claims Resolution Specialist
2 days ago
Dublin, Dublin City, Ireland beBeeClaimsHandler Full time €45,000 - €55,000Role Summary">Claims handlers play a pivotal role in ensuring the smooth resolution of liability claims. As a Direct Settlement Injury Claims Handler, you will be responsible for handling claims from registration to settlement, focusing on direct settlement, pre-litigation, and litigation processes. Your primary objective will be to provide a proactive and...
-
Document Migration Strategist
2 days ago
Dublin, Dublin City, Ireland beBeeClinical Full time €97,100 - €126,730Clinical Document Migration SpecialistThe Clinical Document Governance Management is responsible for the strategy and implementation of clinical document management systems, processes, and standards. This includes Trial Master File (TMF) management, clinical submission preparedness, record retention, TMF integrations for business development and licensing...
-
Digital Document Controller
2 days ago
Dublin, Dublin City, Ireland beBeeDocumentation Full time €60,000 - €83,000About the Role:This is a dynamic position that plays a pivotal role in managing controlled documentation and executing key business processes. As the holder of this position, you will oversee the entire lifecycle of controlled documents from issuance to storage, retrieval, and compliance with document retention policies and regulatory requirements. The role...