Boston Scientific designs, produces, and markets medical devices. As an employer, Boston Scientific fosters a team-based environment that values collaborative e
Senior Manager, Medical Safety
Location
Minnesota + 1 moreAll locations: Minnesota | Massachusetts
Posted
2 days ago
Salary
$125.8K - $239K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Manager, Medical Safety
Boston Scientific
Title: Senior Manager, Medical Safety Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove Job Description: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About this role: At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 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. Work model, sponsorship, relocation: 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: $ 125800 Maximum Salary: $ 239000 Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. 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.
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