Join to apply for the Medical Writer role at eir evo talent
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. Stamp1G, Stamp 4, Irish/British/EU passport.
For more information please apply here or contact Harleen Tora/harleen.tora@eirevo.ie
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.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Writing/Editing
* Industries
* Pharmaceutical Manufacturing
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