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Women's Health Medical Affairs Manager Job

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Date: Dec 4, 2018

Location: Minnetonka, MN, US, 55343

Company: Boston Scientific

Additional Locations: US-MA-Marlborough

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

The Women’s Health Medical Affairs Manager assists with developing and assessing the clinical strategy for certain products and aspects of the Women’s Health franchise including pelvic floor repair, stress urinary incontinence, treatment of fibroids/polyps, abnormal uterine bleeding and more recently, ovarian cancer. 

This position will be assessing the Clinical needs in the product development process (PDP), finding key clinical data gaps and developing plans to fill them, designing the initial  clinical trial proposals, reviewing Investigator Sponsored Research (ISR) and other study requests from external investigators, leveraging existing product clinical data for developing appropriate product positioning for patients and physicians, maintaining effective and strong working relationships with global KOLs, and helping develop and review marketing materials.  This position collaborates closely with Marketing, R&D, Health Economics & Market Access, Regulatory and Quality.   

 

Your responsibilities will include:

  • Participate on internal project teams as the primary Clinical Sciences Representative providing appropriate information on clinical needs, obtaining information to meet evidence goals, reviewing clinical inputs in PDP deliverables, and being the “voice of Clinical”
  • Support divisional clinical strategy planning in prioritizing cadence of trials & in designing trials to meet anticipated regulatory requirements & physician expectations for performance
  • Familiar with current clinical literature regarding BSC and competitors Women’s Health products
  • Understand data gaps in the literature and develop scientific strategies to close gaps that are considered keys to the success of the UroPH stone franchise.
  • Develop a systemized and structured literature monitoring process for the BSC Women’s Health products
  • Identify and develop relevant partnerships with the key opinion leaders (KOL), globally, through collaborative partnerships
  • Develop and manage the publication strategy for the Women’s Health 522 FDA clinical studies through partnerships with the study site investigators and internal functions
  • Manage the 522 FDA clinical study report submission process including report timeline, content and response resolution
  • Monitor and ensure compliance with company policy and procedures with particular attention to HCP Global Compliance guidance.
  • Develop and manage project budgets for any clinical evidence needs
  • Reviews and approves Sales & Promotional materials as the Clinical representative per the BSC SOP
  • Serve as the clinical liaison between the Women’s’ Health Franchise and Project teams, Regulatory, and R&D helping with identification of unmet medical needs, ascertaining voice of the customer, and conducting interim product reviews
  • Assist with review and/or development of clinical study protocols for evidence strategy needs
  • Develop and manage clinical evidence strategy to support new product launches, existing product regulatory submissions, and clinical evidence to support reimbursement positions.
  • Manage ISR process for Women’s Health Franchise by collaborating with internal stakeholders during all aspects of ISR management from application submission to final study report
  • Assist with process improvement activities for evidence strategy planning and literature/science reviews
  • Partner with Women’s Health Franchise medical education lead to identify areas to improve use of published literature for physician education

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s Degree in Biology, Chemistry or other scientific field or an equivalent combination of experience and education
  • 8 years of industry experience
  • 5 years of project management experience
  • Experience in working with the Investigator Sponsored Research program within Research & Education Grants
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Preferred Qualifications

  • Experience in medical device product development processes
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more projects/programs and/or operations.
  • Leadership abilities – lead and direct cross functional teams including high level members of clinical and marketing functions

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 438752

 


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