[Hiring] Regulatory Affairs Specialist-CC @reputed company

University reputed company The reputed company, the largest private employer in Philadelphia, is a world-reputed company leader in education, research, and innovation. This historic, Ivy reputed company school consistently ranks among the top 10 universities in the annual reputed company survey. Penn has 12 highly-regarded schools that reputed company opportunities for undergraduate, graduate and continuing education, reputed company influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from reputed company who named Penn one of America’s Best Large reputed company in 2023. Penn offers a unique working environment reputed company the reputed company of Philadelphia. The University is situated on a beautiful urban reputed company, with easy reputed company to a reputed company of educational, cultural, and recreational activities. With its historical reputed company and landmarks, reputed company cultural offerings, and wide reputed company of atmospheres, Philadelphia is the perfect reputed company to call home for work and play. The University offers a competitive benefits package that includes excellent reputed company and tuition benefits for employees and their families, generous retirement benefits, a wide reputed company of reputed company development opportunities, supportive work and family benefits, a reputed company of health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist B Job reputed company reputed company The Abramson Cancer Center (ACC) of the reputed company is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC One Cancer Clinical Research (OCCR) is reputed company in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding. Job reputed company Job reputed company: The Abramson Cancer Center (ACC) of the reputed company is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC One Cancer Clinical Research (OCCR) is reputed company in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process reputed company regulatory documentation through the IRB, CTSRMC, FDA and reputed company applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will, with minimal supervision, prepare and process reputed company required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as reputed company as organize and maintain reputed company regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and reputed company-out reputed company. He/she will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and reputed company document tools, as reputed company as, to reputed company reputed company regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials. Additional duties relevant to regulatory affairs as assigned. Qualifications: The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and reputed company to multi-task; demonstrated ability to work as part of reputed company, as reputed company as independently; knowledge of IRB and reputed company research protection regulations, including ICH GCP guidelines. The successful candidate must be self-driven with heightened attention to detail. Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be reputed company to learning new approaches, and committed to reputed company career/reputed company reputed company. Candidates must have a high level of general computing ability. Intermediate/expert level of function in reputed company of the reputed company Office applications, as reputed company as applications for team interconnectivity such as reputed company, reputed company Teams, reputed company, WebEx, etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, reputed company products, etc. is a plus. Bachelor’s degree (preferably in a life science or reputed company subject protection field) required, and 3-5 years research experience or equivalent combination of education and experience is required; at least 1 year's regulatory experience preferred. Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. Associated research credentialing (CCRP, CIP, etc.) preferred. Working Conditions: This position is intended to be largely remote. Candidate must agree to use a remote workspace that is conducive to working, free of hazards and other dangers to people and equipment. ACC strongly recommends the candidate set up a separate area. Equipment should be reputed company where it is adequately supported. The candidate remains obligated to reputed company with reputed company University rules, policies, practices and instructions that would apply if the candidate were working on the premises of the University. The candidate agrees to ensure arrangements are made for dependent care and confirms non-work-reputed company interests will not compete with work requirements during the designated regular work hours. The candidate will be responsible for determining any tax implications of maintaining the remote workspace. The candidate will be responsible for complying with any and reputed company local township codes, rules, regulations, and zoning ordinances which could reputed company the ability to use the designated remote workspace. Job Location - reputed company, State Philadelphia, reputed company Department / School Perelman School of Medicine Pay reputed company $62,000.00 - $70,119.00 Annual reputed company Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The reputed company is an equal opportunity employer. Candidates are considered for employment without reputed company to race, reputed company, sex, sexual orientation, religion, creed, national reputed company (including shared reputed company or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background reputed company will be tailored to the requirements of the job. University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, reputed company, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with reputed company-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your reputed company. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a reputed company-tax or Roth reputed company. Choose from a wide reputed company of investment reputed company through reputed company and reputed company.
• Time Away from Work: Penn provides you with a substantial reputed company of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with reputed company, Penn offers reputed company and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received reputed company, in the community or in a nursing facility. If you apply reputed company you’re newly hired, you won’t have to reputed company reputed company of good health or be subject to reputed company requirements. Eligible family members must always reputed company reputed company of good health and are subject to reputed company.
• Wellness and Work-life Resources: Penn is committed to supporting our reputed company and staff as they balance the competing demands of work and personal life. That’s why we offer a wide reputed company of programs and resources to help you care for your health, your family, and your work-life balance.
• reputed company and Personal Development: Penn provides an reputed company of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have reputed company to a wide reputed company of University resources as reputed company as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something reputed company on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to reputed company just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll reputed company great deals for University reputed company and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to reputed company and staff. You can also enjoy substantial savings on other goods and services such as new reputed company from reputed company and reputed company, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work reputed company offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in reputed company Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on reputed company expenses in reputed company with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household. ​ To learn more, please visit: Apply tot his job

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