Senior Manager, Medical Safety

Boston Scientific•Maple Grove, MN

8d•$125,800 - $239,000•Hybrid

About The Position

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 at 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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