Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Clinical Strategy Specialist

S

SSi People

Clinical Strategy Specialist

Andover, MA
Full Time
Paid
Similar Jobs
  • Responsibilities

    Job Description

    JOB TITLE: CLINICAL STRATEGY SPECIALIST II - REMOTE - 3 OPENINGS

    DURATION: 6 MONTHS (with potential hire or extension)

    LOCATION: ANDOVER, MA

    PAY RATE: $51.89/HR ON W2 WITH NO BENEFITS

     

    COMMENTS:

    • MDR is preferred
    • Orthopedic Exp or Spine
    • More of a strategic thinker
    • Must have writing experience with Clinical Activity Reports
    • FDA
    • Most folks wont have FDA and MDR but if you find someone with both that would be perfect
    • Understanding the Regulated industry
    • Understanding Clinical Studies
    • Must be degrees

    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 organisation 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 commercial
    • Able 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 approaches
    • Excellent 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

    Company Description

    Founded in 1998 and located in Cranberry Twp., PA. SSi People is an organization with extensive staffing industry experience within several labor verticals throughout the United States for Fortune 1000 companies. Whether you’re a company looking for talented people to fill demanding positions or a skilled professional looking for the right company to work with and build a career, the search can seem endless. In today’s fast paced, get-it-done-yesterday world of business, it’s become harder than ever for the right people and the right companies to come together. Opportunities and qualified people often miss each other, so the search goes on. At SSi People, our job is to end the search. We connect companies to talent. It’s not easy, but it’s what we do best.