Job Overview
The Clinical Evaluation Reporting Specialist is tasked with creating Clinical Evaluation Reports (CERs) for Terumo Blood and Cell Technologies (TBCT) products. This involves utilizing product labeling, preclinical and clinical data, published literature, risk management documents, complaints, post-market surveillance, and adverse event reports. The Specialist coordinates with various departments to gather necessary documentation and directs them on the required information for CERs. Responsibilities include data collection, appraisal, and extraction from safety and performance data, as well as compiling and authoring Systematic Literature Reviews (SLRs), CER assessments, new CERs, and updates.
Key Responsibilities
- Lead the development of CERs by collaborating with stakeholders from Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, and other departments to gather relevant documentation.
- Work with information specialists to conduct systematic literature searches on TBCT products and their equivalents or competitors.
- Review and appraise published literature to identify relevant articles for the safety and performance of TBCT products.
- Collaborate across departments to understand regulatory submissions, develop literature search strategies, facilitate SLRs, compile necessary CER inputs, analyze product complaints, conduct adverse event and recall searches, and compile preclinical and clinical data.
- Author drafts of SLRs, CER assessments, new CERs, and updates based on business and research priorities.
- Manage document reviews, reconcile comments, and finalize and approve CERs.
- Provide input on risk management deliverables, clinical research, and literature evidence for product development.
- Stay updated on CER regulatory requirements for all applicable countries.
- Develop policies and procedures related to Clinical Evaluation Reviews and Reporting.
- Train and guide contractors on CER development.
- Disseminate findings from CER updates.
- Develop logistics for SLRs and CERs, including deliverables, timelines, and draft reviews.
- Ensure compliance with all applicable laws, regulations, standards, and company procedures.
Minimum Qualifications
- A graduate degree (e.g., MS, PhD) in a scientific, biological, medical, or regulatory discipline, or equivalent education and experience.
- Five years of experience with knowledge in research methodology, information management, relevant databases (e.g., PubMed), regulatory requirements, medical writing, systematic review, and clinical data appraisal.
- Experience in clinical evaluation reporting in academic or medical device/pharmaceutical industry roles.
- Understanding of clinical research and regulatory guidelines.
Skills
- Leadership and interpersonal skills to develop and maintain interdepartmental relationships.
- Ability to work independently and as part of a team.
- Effective prioritization and management of multiple projects.
- Presentation skills for diverse audiences.
- Development and implementation of global policies and procedures.
- Analytical skills for information from multiple sources.
- Understanding of scientific/clinical research methodology.
- Knowledge of regulatory processes (e.g., CE Marking, IDE, PMA, 510(k)), GCP procedures, and legal compliance.
- Proficiency in software programs (e.g., Microsoft Office).
- Strong writing and critique skills for clinical and regulatory documentation.
- Project management skills for effective execution and management.
