Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove
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.
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: 630280Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.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.
