Sci Comm Specialist III

Role Overview 

The Scientific Communications Specialist III (Sci Comm P3) plays a critical role in supporting clinical evaluation and post-market clinical follow-up activities for the BSC Urology Division while safeguarding the safety and clinical compliance of Boston Scientific’s global product portfolio. This position contributes to key deliverables such as literature reviews, Clinical Evaluation Plans and Reports (CEP/CER), Post-Market Clinical Follow-Up Plans and Evaluation Reports (PMCF-P/PMCF-ER), real-world evidence study reports, and PMCF activity reports. 

In addition, the role involves the analysis, documentation, and communication of clinical product risk throughout the project and product lifecycle. Key responsibilities include identifying safety signals, assessing risk, and guiding teams to maintain alignment with regulatory and corporate standards. By ensuring regulatory compliance, this position helps drive product approvals, market expansion, and fulfillment of post-market obligations. 

The Sci Comm P3 collaborates closely with senior members of the Urology Sci Comm team and cross-functional partners in Regulatory Affairs, Research & Development, Design Quality Assurance, Clinical Strategy, Clinical Operations, and Medical Safety to deliver accurate, timely, and impactful documentation. This role also plays an important part in advancing AI-driven transformation of the literature review process, leveraging technology to improve efficiency and accelerate identification of relevant clinical outcomes. 

 Responsibilities 

• Produce and maintain Clinical Evaluation Reports (CERs) and related documents (CEPs, PMCF Plans/Reports, SSCPs) for the global product portfolio by analyzing clinical data, risk documentation, complaints, and scientific literature, ensuring compliance with company SOPs and regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA) 

• Contribute to literature reviews by screening and extracting relevant data using manual and AI-based methods, analyzing literature data, and developing state-of-the-art reports that summarize disease states, clinical outcomes, and therapeutic alternatives. 

• Support AI transformation of literature reviews, including AI tool and workflow development, defining data elements, and maintaining data dictionaries. 

• Contribute to clinical evaluation strategies, defining evidence requirements, safety/performance objectives, and PMCF plans. 

• Contribute to addressing clinical queries from regulatory bodies regarding product safety and performance.  

• Participate in new product development and sustaining projects, providing clinical evaluation input.  

• Coordinate and collaborate with cross-functional teams to gather input, review, and approve deliverables. 

• Manage document timelines to meet internal procedures and global regulatory requirements. 

Minimum Qualifications 

• Bachelor’s degree and minimum of 3+ years of related work experience in Life Sciences, Biomedical Engineering, or related field (Clinical Evaluation / Medical Writing / Clinical Trials / Medical Affairs). Advanced Degree preferred (PhD, PharmD, MD). 

• Experience in clinical evaluation, medical writing, or regulatory affairs within the medical device industry.  

• Strong understanding of EU MDR and global regulatory requirements, along with knowledge of risk management principles and clinical research processes. 

• Excellent analytical, writing, and communication skills.  

• Ability to manage multiple projects and collaborate effectively in cross-functional teams. 

Preferred Qualifications 

• Experience writing CERs and related documents compliant with EU MDR 

• Excellent attention to detail and strong organizational skills 

• Solid understanding of business procedures, quality systems, and regulatory compliance 

• Experience with systematic literature review methodologies and literature management software such as Distiller and EndNote 

• Interest in or foundational training in AI technologies and their application in healthcare or scientific research and data analysis.  

Internal candidates’ requirements:

• A year in the current position, in the company.
• Performance Evaluation: Successful or above
• Don't have disciplinary actions in the last 6 months.
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