Senior Clinical Scientist - MDR Job Listing at Kelly Services in Irvine, CA (Job ID 9412952)

Description

Summary:
Operating on behalf of the Company, this individual will have strong scientific expertise to provide insights and strategic direction to develop evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.
Responsibilities:

• Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and Medical Writing teams, to enable optimized engagement leading to delivery of clinical project commitments as required (delivery on time, within budget and in compliance with regulations and SOP);
• Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;
• Provide input to clinical trials that meet MDR compliance as well as the NPD / LCM needs;
• Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc;
• Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for MDR compliance, marketing authorization (eg. MDD transitioning to MDR), line extensions, etc, including during sponsor regulatory inspections; 
• Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence supporting MDR transition to compliance;
• Act as the subject matter expert (SME) for product-specific and state of the art literature reviews, particularly for clinical evaluations. Lead the clinical aspects of labelling review for on-market products undergoing transition to EU MDR with respect to sufficient clinical evidence. Responsible for product Clinical Development Plans (CDPs), including PMCF plans for products intended for EU under EU MDR and leading such PMCF planning activities.

Functional and Technical Competencies:

• A broad and extensive understanding of product life cycle processes, team dynamics, related healthcare market environment, and global clinical trial regulations, (e.g., European Medical Device Regulations [MDR]);
• Ability to provide strategic and scientific clinical research input to achieving compliance across NPD and LCM (New Product Development and Life-Cycle Management) projects
• Proven track record in clinical / surgical research setting, on time and in compliance to SOPs and regulations;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Ability to lead teams to deliver critical milestones, including complex projects;
• Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;
• Change agent in team development and progression with new compliance-related processes; 
• Broader understanding of Real World Evidence generation pathway to support post market follow-up studies.

Leadership Competencies:

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by supervisor or Chief Compliance Officer.
• Performs other related duties as required.
• Strong leadership required in alignment with Leadership Imperatives: Connect, Shape, Lead, Deliver.

Qualifications:  

• A Bachelor's degree in Biological Science or related discipline. Ophthalmology area experience.
• Focus in medical device/surgical products.
• A minimum of 8 years related scientific / technical experience, including role within Clinical Research/Clinical Trial Lifecycle. 

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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