Job Type: 12 month (Fixed Term Contract)
Location: Cork/Dublin Work Model: Hybrid (1 - 2 days onsite at Customer Site in Cork per month with occasional travel to Dublin as per business needs). Description Document Development and Writing: Author, review, and finalise high-quality clinical trial documents, including but not limited to:Study Protocols and Protocol Amendments: Develop comprehensive and scientifically rigorous protocols that align with regulatory and ethical standards.Initial Investigator's Brochures (IB) and IB Updates: Create and update IBs to ensure they reflect the most current clinical and non-clinical data.Clinical Study Reports (CSRs): Prepare detailed and accurate CSRs that summarize study results and support regulatory submissions.Develop and edit manuscripts for publication in peer-reviewed journals, ensuring they meet journal-specific guidelines and uphold the highest standards of scientific integrity.Ensure all documents are written in clear, concise, and grammatically correct English, adhering to regulatory and company-specific guidelines.Regulatory Compliance and Quality Assurance: Ensure all documents comply with ICH GCP, regulatory requirements, and internal SOPs.Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.Review and interpret clinical data to ensure accuracy and consistency in documentation, aligning with study objectives and regulatory expectations.Scientific and Literature Support: Conduct thorough literature reviews to support clinical research projects, ensuring that all documents are grounded in the latest scientific evidence and industry best practices.Synthesize complex scientific and clinical data into clear, concise, and compelling narratives for regulatory submissions, publications, and internal communication.Project Management and Coordination: Plan and manage timelines for document development, ensuring timely delivery of high-quality deliverables.Coordinate with internal and external stakeholders (e.g., investigators, regulatory agencies, CROs) to gather necessary input and resolve queries.Collaboration and Communication: Work effectively across cultures and time zones, fostering collaboration with global teams.Provide expert guidance to team members on medical writing best practices, regulatory requirements, and document standardization.Document Management: Ensure final documents and supporting quality check documentation are archived in the appropriate document management system.Maintain organised records of all drafts, revisions, and approvals for future reference and audits.Key Experience and Skills: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.Strong experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.Deep understanding of clinical research methodologies and regulatory requirements (In-depth knowledge of ICH GCP guidelines, and compliance standards e.g., FDA, EMA).Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.Exceptional writing skills: Demonstrated ability to write clear, concise, and scientifically accurate documents.Strong project management skills: Ability to plan, prioritise, and deliver high-quality work under tight deadlines.Attention to detail: Meticulous approach to ensuring accuracy and consistency in all deliverables.Technical proficiency: High-level expertise in Microsoft Word, Excel, and other tools for creating tables, graphs, and figures.Candidates should hold appropriate RTWs for Ireland i.e.
Stamp 1G, Stamp 4, Irish/British/EU passport. For more information please apply here or contact Harleen ******.
Ref: EET6766 Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.
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