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Post-Market Clinical Strategy Manager II Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): US-MA-Marlborough; US-MA-Boston; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minneapolis

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 the role:

The Post-Market Clinical Strategy Manager II provides strategic, performance and people leadership for the Urology and Pelvic Health Post-Market Clinical Follow-up team.  They have comprehensive leadership and technical skill sets and a thorough understanding of the relevant regulations and therapeutic areas as it relates to the development and execution of post-market evidence strategies for UroPH EU medical devices.  They provide innovative solutions and lead resolution of cross-functional issues and process improvement efforts. They are an SME and represent their function to internal and external cross-functional partners, while also training junior level specialists. They act as a project manager to maintain a complex array of clinical documentation for new submissions and sustaining work.

 

Your responsibilities will include:

  • Provide leadership for the UroPH PMCF team, and broader divisional stakeholders for Post-Market Clinical Follow-up (PMCF) evidence requirements, activities, costs and strategies. Represent Clinical Sciences in the broader business portfolio optimization and MDR decision discussions as applicable.
  • Develop and maintain partnerships with key stakeholders in Product Risk, Medical Affairs, Medical Safety, Clinical Operations, Biostatistics, HEMA, Regulatory, Legal and other functional groups to support the success of both PMCF and the broader UroPH evidence strategies.  Able to engage all relevant stakeholders to ensure that PMCF activities are aligned with broader portfolio decisions.
  • Drive PMCF, Product Risk and DQA collaboration for all PMCF strategy and documentation – ensure that Product Risk, PMCF and Medical Safety are aligned on all product safety and performance objectives, product evidence needs, and PMCF activity execution and timelines.  Ensure PMCF evidence activities meet both the quantity and quality of evidence needed within agreed upon timelines and cadences.  
  • Utilize deep expertise in EUMDR PMCF, PMS and CER regulations, their application and ongoing guidance to drive current needs to closure and forecast long term divisional needs.  Provide leadership where needed on internal BSC PMCF policy and procedure efforts and initiatives.  Develop internal processes that support cross-functional needs in Quality, Supply Chain, PMO, Clinical and others as needed.
  • Represent PMCF team, strategy and activities as appropriate during internal and external audits, Notified Body questions, etc.  Partner across BSC divisions, functions and stakeholders to collect internal and external feedback related to PMCF strategy and activities including audits, industry standard guidance, Notified Body feedback etc. to drive consistency across PMCF initiatives and leverage best practices.
  • Develop short- and long-term PMCF strategies across all franchises to meet UroPH clinical evidence needs. Develop and drive innovative PMCF thought work and proposals to meet MDR needs that serve the UroPH business. Closely collaborate with other UroPH Clinical functions to provide expertise in ensuring PMCF plans and activity proposals meet business needs, and articulate risks and benefits for options.
  • Develop mechanisms to assess and communicate MDR evidence risk for UroPH product portfolio, both written and verbal.
  • Develop and maintain strong partnerships with physicians and institutions to enable PMCF leadership team to successfully plan and collect PMCF data.  Collaborate with Sales and Marketing leadership to identify physicians and institutions interested in clinical research related to PMCF and drive cross-functional partnership.
  • Support and direct team in planning, design and execution for User Feedback Evaluations (UFEs), Retrospective Data Analyses (RDAs) and Real World Evidence (RWE) generation.  
  • Support PMCF leadership team and BSC corporate clinical team in evaluation of vendors and databases for feasibility and appropriateness related to user-feedback evaluations, retrospective data analyses and real-world data
  • Lead, manage and develop a high-performing team of PMCF managers and staff.  Foster a diverse workplace and create an inclusive culture that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Drive planning, execution and management of budget and schedule related to retrospective data analysis and user feedback evaluation workstreams

 

Required qualifications:

  • Bachelor’s degree
  • 7+ years of work experience in related field
  • 4+ years of people leadership/management experience
  • 4+ Medical/technical/scientific writing experience
  • Knowledge of the European Medical Device Regulation (EU MDR)
  • Excellent communication and interpersonal skills, including strong customer and physician-facing skills
  • Proven ability to work collaboratively and influence a broad range of global stakeholders

 

Preferred qualifications:

  • Advanced degree (Master’s degree and above) in related area
  • Demonstrated strategic perspective and ability to align activities with business vision and purpose
  • Urology and Pelvic Health product and/or therapeutic knowledge/experience
  • Medical/technical/scientific writing experience for EU MDR CER, PMCF and PMS plans and reports
  • Experience working with product development teams (e.g. Medical, Clinical, R&D, Regulatory, Design Quality Assurance)
  • Experience interacting with Regulatory Authorities and Notified Bodies, including audit experience
     

 

Requisition ID: 537454

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 

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.


Nearest Major Market: Boston

Job Segment: Medical Device, Supply Chain Manager, Medical Research, Clinical Research, Data Analyst, Healthcare, Operations, Data

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