Description
PLEASE NOTE: Must be legally authorized to work in the United States for any employer without sponsorship. For immediate consideration, please apply.
Kelly® Science & Clinical is seeking a Senior Regulatory Clinical Science Specialist for a temporary position (with potential to extend/convert) at a leading client in Summit, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate:
Up to: $75/Hour (commensurate with experience)
Overview:
The Temporary Senior Regulatory Clinical Science Specialist will report to the Director, Regulatory Clinical Science and is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high-level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.
Schedule:
Friday – Monday, 1st/Day: Standard Hours
Responsibilities:
• Draft essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing and reconciliation.
• Review, edit and approve all final submissions in DocuBridge.
• Assist in daily operations outside of essential BLAs, including protocol reviews/amendments, provide regulatory input on day-to-day issues, and provide regulatory documents to other departments.
• Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.
• Assemble the reporting of clinical studies performed by IBRX or by CROs.
• Draft written summaries for regulatory submissions including INDs, NDAs, and BLAs.
• Prepare or review documents including investigator brochures, pharmacy manuals, protocols, clinical study reports , annual reports, DSURs, and clinicaltrials.gov entries.
• Provide support and training to others in the preparation, analysis, and documentation of studies.
Qualifications:
Education & Experience”
• Bachelor's degree in life sciences or a related field required; 7+ years of relevant regulatory clinical Science experience is required.
• Or Master's degree in life sciences or a related field required; 5+ years of relevant regulatory clinical Science experience is required.
• Mid-level regulatory or clinical operation expertise preferred.
• Experience in the preparation of the submission of clinical modules in eCTD format is preferred.
• Familiar with organizing responses to Health Authority information requests is preferred.
• Familiarization with regulatory submissions internationally is preferred.
Knowledge, Skills & Abilities:
• Knowledge of Health Authority clinical guidance documents and requirements.
• Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines.
• Strong knowledge of clinical documentation.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
• Strong organizational skills, written and oral communication skills, and attention to detail.
Working Environment/Physical Environment:
• This is a full-time position (40 hours per week) on-site (Monday through Friday).
• A Senior Regulatory Clinical Science Specialist may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project-team basis.
• Lift and carry materials weighing up to 20 pounds.
What Happens Next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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