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Clinical Strategy Specialist II

Company: Kelly Services
Location: Peabody
Posted on: April 9, 2021

Job Description:

Kelly Services is seeking a Clinical Strategy Specialist for one of our clients in--Andover, Massachusetts.

  • 6 month contract
  • Openings: 3
  • Pay: Negotiable--Description:--The Clinical Strategy Specialist (CSS) will provide strategic clinical direction for the life cycle of the products across Smith & Nephew's Orthopaedics portfolio. This will be accomplished through awareness of franchise priorities to align clinical activities accordingly and plan ahead. From the franchise and overall perspective, the CSS will have a clear understanding of the company's current global investment in clinical evidence collection activities including Smith & Nephew initiated studies, Investigator initiated studies and Data Mining activities and will set strategies to identify and fill any evidence gaps. The CSS will work closely with other stakeholders on regulatory related activities and submissions. The CSS will work directly with clinicians to plan and manage evidence generation activities including the development of methodologically sound clinical study protocols and in the generation of reports to communicate the findings to stakeholders across multiple functions.Responsibilities:
    • Applying a comprehensive understanding of S&N's commercial priorities in setting the clinical strategy for the Orthopaedics portfolio: 20%
    • Working with the New Product Development and Marketing teams to establish user needs, claims, indications and market strategies, and develop the evidence generation strategies to meet those needs: 10%
    • Working directly with clinicians and clinical sites to initiate and manage clinical evidence generation activities, including those initiated internally and externally for both new and legacy products: 30%
    • Generating documents in support of evidence generation activities including protocols and reports: 20%
    • Communicating strategies and findings from clinical activities to cross-functional stakeholders at all levels of the organisation: 10%
    • Responding to questions from regulatory authorities to ensure adherence to the appropriate regulations: 10%Education: Minimum of a Bachelor's degree in a relevant discipline. Master's degree or PhD would be beneficial.Licenses/ Certifications:Experience:4-7 years' experience in medical devices or pharmaceutical organization in a Clinical, Research & Development, Scientific and Medical Affairs or Regulatory role.Experience in developing strategies to generate clinical evidence and working with clinicians to establish and manage clinical evidence generation activities is required.Experience in the Orthopaedics field desirable.Competences:A strategic thinker who can develop competent, deliverable strategies considering high standards of regulatory rigour and commercialAble to communicate difficult concepts effectively and willingness to negotiate/work closely with others; solves ambiguity and ensures conclusions.Self-motivated and able to work independently, whilst maintaining inclusive approachesExcellent time management skills and ability to work under pressure to deadlines.Must exhibit high quality, ethical and compliant work habits.Experience in using Microsoft Word, Excel, and PowerPoint.Excellent scientific/technical writing skills.Physical Demands: Sitting in front of a computer 90%+ of dayWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Peabody , Clinical Strategy Specialist II, Other , Peabody, Massachusetts

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