Boston Scientific Product Risk Specialist II 

El Salvador, La Libertad, Lourdes 

264638279

Costa Rica-Heredia

Hybrid Roles:

About the role:

The Scientific Communications Specialist II contributes to clinical evaluation and post-market clinical follow up reporting for the BSC Urology Division. Typical deliverables include literature reviews, clinical evaluation plans and reports (CEP/CER), post-market clinical follow-up plans and evaluation reports (PMCF-P/PMCF-ER). This role supports product approval, market expansion, and mandated post-market requirements and partners closely with more senior members of the Scientific Communications team as well as cross-functional partners in Regulatory Affairs, Research & Development, Design Quality Assurance, Clinical Strategy, Clinical Operations, and Medical Safety.

Your responsibilities include:

• Update CERs and related documents (CEPs, PMCF Plans, PMCF Reports, SSCPs) by incorporating clinical investigation data, PMCF data, and scientific literature; reviewing hazard analyses and other risk documents, reviewing product complaint data, and analyzing scientific data.
• Conduct literature reviews, screening literature and extracting relevant data elements.
• Contribute to generating and updating state of the art reports characterizing disease states, clinical outcomes, and therapeutic alternatives for assigned device portfolios.
• Contribute to medical writing of study reports for BSC-sponsored real-world evidence studies, PMCF activities, and systematic literature review and meta-analysis reports.
• Contribute to addressing clinical queries from regulatory bodies in support of product safety and performance.
• Coordinate cross-functional stakeholder teams for input, review, and approval of assigned deliverables and projects.
• Manage document timelines required by BSC procedures, product development teams, clinical teams, and global Regulatory Bodies.
• Develop understanding of assigned therapeutic areas, devices, and alternative therapies.
• Contribute as a participant in new product development and sustaining core teams, contributing to clinical evaluation and cross-functional deliverables.
• Contribute input into hazard analyses and instructions for use for assessment of potential harms and support of product safety and performance.
• Contribute to the review of cross-functional deliverables, including risk documentation and PSURs for assigned products.
• Develop knowledge in evolving requirements of international regulations, including requirements laid out in EU MDR.
• Contribute to CER process development and improvement activities.
• Contribute to team development activities (e.g. knowledge sharing, presenting in team meetings).

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s degree with 2+ years of related work experience (Clinical Evaluation / Medical Writing / Clinical Trials / Medical Affairs / Epidemiology)
• Knowledge of clinical research methodologies (clinical investigation design and biostatistics, systematic literature review)
• Ability to analyze, interpret, and summarize scientific data and medical literature
• Working knowledge of Adobe PDF, MS Word, and Excel
• Proven ability to manage timelines
• English advanced (C1 - 90 - 99%)

Preferred Qualifications

• Medical device industry experience
• Understanding of information management (experience with relevant databases such as PubMed, Ovid, or Embase)
• Experience with literature management software such as Distiller and EndNote