Senior Clinical Strategy Specialist - Austin, United States - Taleo BE
Description
Senior Clinical Strategy SpecialistLife Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.
This role will support the ENT business franchise.
The Senior Clinical Strategy Specialist (SCSS) will function as a subject matter expert within the organization and operates as technical lead on large scale projects and/or multiple projects.
The SCSS will develop and execute clinical evidence generation plans for new product introduction globally, expanded adoption of products and securing continued access of approved products.
The SCSS will provide strategic clinical direction for the life cycle of the products across Smith & Nephew's ENT portfolio.
The SCSS will have a clear understanding of the company's current global investment in clinical evidence collection activities and will set strategies to identify and fill any evidence gaps.
The SCSS will work directly with health care professionals to plan and manage evidence generation activities including the development of methodologically sound clinical study proposals / protocols and in the generation of reports to communicate the findings to stakeholders across multiple functions.
The SCSS will participate in clinical study or data collection activities to ensure the available clinical and health economic evidence for their portfolio of products meets internal and external requirements.
This individual will work closely with internal Global Clinical & Medical Affairs (GCMA) functions, Market Access, Regulatory, R&D and Marketing partners and with external health care professionals.
Apply a comprehensive understanding of S&N's commercial priorities in development of the clinical strategy for ENT portfolio products.
Work with the New Product Development teams to establish user needs, claims, indications and market strategies, and develop the evidence generation strategies to meet those needs.
Review clinical and health economic evidence and identify evidence gaps. This includes, but is not limited to, assessing the evidence available through published literature, registries, and unpublished clinical studies.Develop study proposals and initiate clinical activities to support evidence generation needs. Communicate with study investigators and study sites, as applicable, to process and track study proposals, budgets.
Manage ENT Investigator Initiator Studies (IIS) and real world data collection activities to ensure business objectives/processes and study milestones are met.
Create, maintain, contribute to, and/or review Clinical Strategy-assigned documentation supporting the product lifecycle.This may include, but is not limited to, Post-Market Clinical Follow-up Plans, Clinical Development Plans, Clinical Evaluation Reports, Periodic Safety Update Reports, Product Claims Sheets, Risk Management Files, Clinical Benefit Effects Analyses and Instructions for Use.
Review, analyze (as applicable), and document supporting data.Develop reports, as applicable, and ensure data/reports are provided to appropriate stakeholders, ensuring the format is appropriate for its intended use.
Generate publication strategies and write scientific paper and abstracts.Present progress and results to internal stakeholders at all levels of the organization.
May contribute to development or updates of department standard operating procedures (SOPs) and policies.
Support regulatory documentation for new or existing products, as applicable. This may include development of responses for clinical-related questions received from regulatory authorities.
Support both internal and external audits, as needed.
Ensure compliance to applicable processes, quality standards and regulations.
Attend professional conferences and surgeon training labs as appropriate.
What will you need to be successful?
Education:
Minimum Master's degree or equivalent in a relevant discipline. PhD would be beneficial.
Experience:
Minimum 5-years' experience in medical device or pharmaceutical organization or equivalent in clinical/health/science-related discipline
Experience in developing strategies to generate clinical evidence.
Experience working with health care professionals to establish and manage clinical evidence generation activities
In-depth knowledge and experience in clinical research and methodology
Travel:
Up to 20%
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about
Employee Inclusion Groups
on our website (
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
Work/Life Balance:
Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing:
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility:
Hybrid Work Model (For most professional roles)
Training:
Hands-On, Team-Customized, Mentorship
Extra Perks:
Discounts on fitness clubs, travel and more
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We're more than just a company - we're a community Follow us on
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Check our
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Explore our
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and learn more about our mission, our team, and the opportunities we offer.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
our
talent community
.
We're
more than just a company -
we're
a community Follow us on
to see how we support and empower our employees and patients every day.
Check
our
Glassdoor page
for a glimpse behind the scenes and a sneak peek into
You
.
Unlimited
.
, life, culture, and benefits at S+N.
Explore our
new website
and learn more about our mission, our team, and the opportunities we offer.
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