Senior Manager, Medical Safety

About this role This role is responsible for the implementation of practices, policies, and processes for the Interventional Oncology and Embolization Medical Safety team to ensure medical expertise, objective oversight and safety vigilance throughout the total product lifecycle. The Senior Manager, Medical Safety provides oversight, manages and facilitates the completion of accurate, timely, and consistent medical assessments of adverse events and potential adverse events. The Senior Manager, Medical Safety provides leadership to Medical Safety Professionals (non-MDs) to provide high level medical/ therapeutic guidance to internal and external customers. This role may also include individual contributor responsibilities related to Medical Safety oversight of sustaining Interventional Oncology and Embolization therapies and new product development. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include Ensure the processes and training curriculum are current to support medical safety oversight and input into Clinical (BSC sponsored clinical trials) and Quality (product complaint handling) Support risk documentation creation and updates, post-market surveillance reports, clinical trial safety documents Support the Quality organization and assist in the creation, implementation, and harmonization of standard policies and procedures Recognize and direct organizational development needs and opportunities for continuous improvement within Medical Safety In partnership with the Medical Director, this role aligns medical safety strategy, escalates emerging safety signals, and ensures consistent medical decision-making across the product lifecycle. Drive comprehensive, integrated analysis of a potential safety issue throughout the product lifecycle Ensure early medical review of clinical trial Adverse Events to identify unanticipated adverse device effects Represent Medical Safety in cross functional working groups on matters affecting patient safety in functional areas such as clinical studies, post market surveillance and risk management Serve as Acquisition Lead for Medical Safety, participating in integration work groups and identifying potential resourcing needs Manage resourcing needs of the team by maintaining key metrics and allocating resources to achieve feasible workloads and meet deadlines. May also include completing financial reports Leading through Change: With organizational change comes stress and uncertainty- provide support and leadership to analyst team through change and ongoing reorganization Work with leadership to identify work process changes/improvements, convey information to analyst team as available/appropriate Required qualifications Holds current and active RN, NP, CRNP, DNP, or PA license Minimum of 8 years' experience providing direct patient care, preferably in oncology or interventional radiology. Minimum of 5 years' experience within the medical device, pharmaceutical, or related health care industry. Minimum of 2 years' experience leading, managing, or supervising clinical or professional staff. Demonstrated leadership skills, including communication, collaboration, strategic planning, innovation, and critical thinking Preferred qualifications Proven experience as an oncology, interventional radiology, critical care nurse, or advanced practice provider. Demonstrated proficiency in staff leadership, coaching, and professional development. Experience supporting operational safety activities for clinical studies and medical devices. Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices. Requisition ID: 630280 Minimum Salary: $125,800 Maximum Salary: $239,000 Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. Nearest Major Market: Minneapolis Job Segment: Medical Device, Medical Research, Clinical Research, Pharmaceutical, Patient Care, Healthcare, Science #J-18808-Ljbffr Boston Scientific Gruppe