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  • Hello RAPS, I am looking for a Regulatory Affairs Manager in San Antonio, TX for a clinical trial site.  ...

  • Criterion Edge is seeking regulatory writers with significant previous experience with Clinical Evaluation ...

  • Hi Karen ,  I saw your response to Shalin's post and wanted to add few of my queries - 1. How to break ...

Regulatory Job Openings

  • KINDRED REHAB HOSP EAST VALLEY LLC, Arizona, Director of Quality Opportunity Dignity East Valley Rehabilitation Hospital - Chandler, AZ Dignity Health East Valley Rehabilitation Hospital is a joint venture operation and free-standing Post-Acute Inpatient Rehabilitation Hospital between Dignity Health and Kindred Healthcare. Our two-story, 58,000-square-foot facility includes a stroke unit, physical therapy gym and 50 beds to serve patients recovering from significant neurological injury, illness and trauma and similar medical conditions. Located at 1515 W. Chandler Blvd., and employs approximately 190 staff members. The DCQPI assumes responsibility and accountability for the hospital-wide Continuous Quality and Performance Improvement program. The DCQPI will assist the CEO/leadership and Medical Staff to establish priorities for Performance Improvement. He/she ensures that disciplines in the hospital work collaboratively to plan and implement Performance Improvement activities. The DCQPI will focus on measuring, analyzing and trending information in order to improve outcomes. He/she will assure ongoing monitoring of performance to ensure that improvements are sustained. The DCQPI will direct and assist in compliance with federal and state regulations and accreditation standards . High School diploma or GED equivalent required; or degree of higher education preferred. Registered Nurse with current licensure in the State of Arizona, preferred. Certification by APIC (American Practitioners of Infection Control), and NAHCQ (National Association of Health Care Quality) preferred BSN or BS/BA preferred. Two years of experience in an acute hospital or rehabilitation setting preferred. Previous supervisory experience required. Current Basic Life Support/CPR Card preferred Demonstrated ability to plan, coordinate, and evaluate PI activities; effective oral and written communication skills and proficiency in basic computer skills required. Working knowledge of staff development and the educational process, quality improvement, infection control/employee health, and safety/risk management standards. Effective oral and written communication skills, in English with additional languages preferred; proficiency in basic computer skills required. Job : Compliance/Quality/Risk Primary Location : AZ-Chandler-CHC PR & MSA-DIGNITY-KINDRED REHAB HOSP EAST VALLEY LLC Organization : 3199 - CHC PR & MSA-DIGNITY-KINDRED REHAB HOSP EAST VALLEY LLC Shift : Day
  • Kindred Hospital Paramount, California, What makes Kindred Healthcare a great place to work? Our people, of course! Our Quality Coordinator answers this special calling because they have a fundamental, internal drive to directly help people. In return, we serve, develop and respect our employees in environments created to optimize their job effectiveness, experience, and satisfaction. This is who we are. Who are you? To succeed in our high-energy, high reward environment, our clinicians provide compassionate critical care and deliver exceptional patient experiences, meaningful outcomes, and bonds for life. As the most acute level of care in Kindred's continuum, our transitional care hospitals offer the same critical care patients receive in a traditional hospital or intensive care unit , but for an extended recovery period. Our leadership play a vital role in the recovery process for chronic, critically ill and medically complex patients. As a Quality Coordinator you will: Summary: The Quality Coordinator reports to the Director of Quality Management and will assist with data collection and analysis, creating aggregate data reports, open record review, survey preparation and on-going survey compliance, event investigation and management, and other activities related to hospital performance improvement. Work is divided between reviewing open electronic and paper record, on and off the patient unit. Computer data entry and report writing, attendance at meetings and data analysis. Quality Coordinator, Quality Management, Risk Management, CPHQ, Hospital Risk Management, Hospital Quality Management, Hospital Quality, Hospital Risk, Risk Mgr, Quality Mgr, Quality Analysis, Quality Analyst, Quality Clinician, Acute Quality, LVN, LPN, RN, Nurse, Healthcare Quality, Performance Improvement, 90723 Education: From an accredited program leading to licensure as an LPN/LVN or RN Licenses/Certification: Current RN licensure or LPN/LVN licensure Experience: 3 years clinical experience and health care and performance measurement or improvement experience Job : Compliance/Quality/Risk Primary Location : CA-Paramount-Kindred Hospital Paramount Organization : 4003 - Kindred Hospital Paramount Shift : Day
  • Chicago North Campus, Illinois, What makes Kindred Healthcare a great place to work? Our people, of course! Our clinicians answer this special calling because they have a fundamental, internal drive to directly help people. In return, we serve, develop and respect our employees in environments created to optimize their job effectiveness, experience, and satisfaction. This is who we are. Who are you? To succeed in our high-energy, high-reward environment, our clinicians provide compassionate critical care and deliver exceptional patient experiences , meaningful outcomes, and bonds for life. As our most acute level of care, Kindred's transitional care hospitals offer the same critical care patients receive in a traditional hospital or intensive care unit , but for an extended recovery period. Our clinicians play a vital role in the recovery process for chronic, critically ill and medically complex patients . As a Director Quality Management you will: Responsible for planning and implementing the performance improvement program to meet the needs of the hospital. Provides education to medical staff, hospital staff, and Governing Body. Facilitates performance improvement activities, and CQI activities throughout the hospital. Acts as resource person to administrative team, department managers, and medical staff. Performs clinical risk management functions. Assists department managers with preparation for medical staff committees. Oversight responsibility for all regulatory body surveys, such as, JCAHO, State Licensing Review, HCFA (CMS) Validation surveys. Maintains oversight responsibility for all performance improvement activities conducted throughout the hospital. As a Director Quality Management you will have: Bachelor's degree. Certified Professional Healthcare Quality / CPHQ certification preferred. Minimum three (3) years' experience in Quality and/or Risk Management in a hospital setting. Job : Compliance/Quality/Risk Primary Location : IL-Chicago-Kindred Hosp - Chicago North Campus Organization : 4637 - Kindred Hosp - Chicago North Campus Shift : Day
  • Amherst, Massachusetts, The Export Control Compliance Specialist, under the direction of the Sr. Associate Director, Research Compliance, works to implement UMass Amherst’s export control compliance program. The Export Control Compliance Specialist will analyze research projects and activities for potential intersection with U.S. export control laws and regulations (“export controls”), determine if export controls apply, and initiate appropriate action to ensure compliance. The Specialist also provides export control training to campus community members, including faculty, staff, administration, and students.    Essential Functions Analyze, interpret, and apply U.S. export controls laws and regulations, including, but not limited to, the Export Administration Regulations (“EAR,” 15 CFR Parts 730-774), International Traffic in Arms Regulations (“ITAR,” 22 CFR Parts 120-130), and sanctions programs implemented by the U.S. Treasury Department, Office of Foreign Assets Control (“OFAC”), in a university setting. Review and analyze contractual and other documents related to proposing and conducting university research to identify intersections with export controls and, when applicable, develop, implement, and document the appropriate compliance response. Coordinate and communicate with researchers to obtain information necessary to determine whether export controls apply to their research projects and convey the results of export-control compliance analyses. Conduct restricted-party screening of research collaborators and other parties, including, but not limited to, sponsors, coresearchers, primary and subcontractors, and material providers and recipients, to determine potential inclusion on restricted entity/person lists issued by governmental departments and agencies. Analyze research subject matter to determine potential inclusion on lists of export-controlled items, such as the Commerce Control List (“CCL”) and U.S. Munitions List (“USML”). Identify and apply for license and commodity jurisdiction requests to Government entities. Develop and provide export control training to campus community members, including faculty, administrators, students, and other researchers. Attend export control training sessions conducted by Government departments and agencies, including, among others, Departments of Treasury, Commerce, and State. Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure) Bachelor’s degree in Legal studies, Public Administration, Business, Science or engineering, or other related field and two years demonstrated experience implementing and/or enforcing federal or state regulations, preferably in the area of export controls, trade compliance, or sanctions and embargoes, though other regulatory experience may be acceptable. An equivalent combination of education, training, and experience may be substituted. Strong interpersonal and communication skills; ability to interact with a diverse client base, both in writing and orally, including students, staff, faculty and campus and system leadership; ability to deal diplomatically with people at all levels. Excellent written and oral presentation skills, including ability to create compelling presentation materials and give effective presentations. Ability to analyze complex documents and situations, identify workable solutions, and effectively balance service with regulatory compliance. Intermediate level of experience with Microsoft Word, Excel and PowerPoint. Well-developed organizational skills; ability to independently work on multiple projects concurrently and prioritize those projects. Ability to work effectively and be flexible in a fast-paced, high-volume professional environment.
  • Waltham, Massachusetts, We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group supporting the GSK Strategic External Development (SED) organization. At GSK, our CMC regulatory affairs group is responsible for a portfolio of biopharmaceutical products as well as small molecule products.  This role requires you to interact across all the functions to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patients’ lives enabling them to Do More, Feel Better and Live Longer. As an Associate Director CMC Regulatory Affairs, you will be based at our Waltham, MA site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals. The position will include projects in clinical development to study and commercialize important new COVID-19 therapies. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities. You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities. You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.    You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.  You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.   Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a  related scientific discipline. At least 7 years of pharmaceutical company experience.   Preferred Qualifications: If you have the following characteristics, it would be a plus: Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience with direct involvement in regulatory submission preparation across all stages of development. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Detailed knowledge of the drug development and manufacturing and supply processes Understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NMEs and marketed products Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. Excellent verbal and written communication skills. Ability to work independently with minimal supervision as well as in a team environment The ability to successfully influence and negotiate issues at the appropriate level within your organization and/or with regulatory agencies in a variety of settings. Strong problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions.  Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy. Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. Experience of Agency interactions and/or submissions in US, EU, Japan and China. Resourceful, creative, enthusiastic, and results-oriented Self-motivated, assertive, self-confident and acts with a sense of urgency and passion Proven ability to work with a high level of integrity, accuracy, and attention to detail Strong interpersonal skills   Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:   Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.  

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