Rush University Medical Center
Chicago, Illinois
Location: Chicago, Illinois Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: 4 Kellogg Mood Disorder Unit Work Type: Full Time (Total FTE between 0. 9 and 1. 0) Shift: Shift 4 Work Schedule: 8 Hr (7:00:00 AM - 3:30:00 PM), Infrequent Rotation Rush offers exceptional rewards and benefits learn more at our Rush benefits page (). Pay Range: $37.50 - $57.19 per hour Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case. Summary: The RN 1 is a beginning level nurse who utilizes a scientific and theoretical knowledge base along with policy and procedures, standards of care and protocols to guide practice. The RN 1 relies on the experience, judgment and support of others while developing knowledge in practice. The RN 1 exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. Other information: Qualifications: Knowledge: 1.Current State of Illinois Registered Nurse licensure required. 2.Maintain current BLS certification. 3.Bachelor's degree in Nursing (BSN) or Associate's degree in nursing (ADN) (New graduates must have acceptance into an accredited school of nursing within 6 months from date of hire, 4. Within 1 year from the date of hire, employee must be enrolled in a BSN program. 5. RNs hired prior to 10/22/2020 are grandfathered in with an Associate Degree in Nursing (ADN) or diploma in nursing, with no further need to obtain a Bachelor's degree in Nursing (BAN or BSN). 6. Chief Nursing Officer must provide approval for any RNs with ADN degree hired after 10/22/2020, based upon unit need. ADN RNs hired after 10/22/2020 must show continued enrolment towards a BSN degree with a signature of contract stipulating a BSN degree must be completed within 3 years of hire, Failure to do so will result in termination. ADN RNS are not eligible for leveling to RN3. Abilities: 1.Work requires the ability to walk throughout the Medical Center and to be standing or walking most of the designated shift. 2.Work requires lifting or carrying objects 35-40lbs. and supporting and positioning patients, some of whom may exceed 300 lbs. 3.The ability to check documents for errors, use a keyboard to enter or retrieve data, and closely examine specimens, images or reports is required. 4.Work conditions include performing procedures where carelessness could result in injury or illness and/or contact with potentially infectious materials and/or strong chemical agents. Responsibilities: 1.Seeks out resources to assist in the management of new patient situations. 2.Uses evidence based guidelines (P&P, nursing standards of care, protocols and pathways) consistently. 3.Supports a hospital wide innovation to achieve positive outcomes. 4.Establishes a caring, therapeutic relationship with patients and families through effective communication, acknowledgement of patient/family perceptions of health and illness and mutual goal setting for optimal outcomes 5.Treats patients and families with respect and a sensitivity for diverse viewpoints and cultures. 6.Maintains positive, professional relationships with all members of the healthcare team. 7.Works effectively with other professional nurses through mutual support and respect. 8.Demonstrates beginning collaboration skills to meet the needs of patients and families. 9.Utilizes beginning assessment skills to evaluate the physical and psychosocial needs of patient/family. 10.Uses scientific and theoretical knowledge to develop and implement the plan of care for assigned patients with support from experienced staff. 11.Recognizes a change in patient status and seeks appropriate resources to address concerns. 12.Uses medical devices safely and effectively in the delivery of patient care and seeks guidance when needed. 13.Demonstrates accountability for implementing policies related to safe and effective administration of medications. 14.Assesses patient safety needs and implements appropriate strategies (fall precautions, infection control, and suicide risk patient identification) to minimize risk and seeks guidance when needed. 15.Applies the teaching-learning process effectively to meet the learning needs of patients and families. 16.Demonstrates accountability for own professional practice, including progress toward achievement of annual goals with guidance. 17.Supports unit goals and change initiatives. 18.Demonstrates beginning delegation skills to meet the needs of patients. 19. Other duties as assigned. Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Location: Chicago, Illinois Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: 4 Kellogg Mood Disorder Unit Work Type: Full Time (Total FTE between 0. 9 and 1. 0) Shift: Shift 4 Work Schedule: 8 Hr (7:00:00 AM - 3:30:00 PM), Infrequent Rotation Rush offers exceptional rewards and benefits learn more at our Rush benefits page (). Pay Range: $37.50 - $57.19 per hour Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case. Summary: The RN 1 is a beginning level nurse who utilizes a scientific and theoretical knowledge base along with policy and procedures, standards of care and protocols to guide practice. The RN 1 relies on the experience, judgment and support of others while developing knowledge in practice. The RN 1 exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. Other information: Qualifications: Knowledge: 1.Current State of Illinois Registered Nurse licensure required. 2.Maintain current BLS certification. 3.Bachelor's degree in Nursing (BSN) or Associate's degree in nursing (ADN) (New graduates must have acceptance into an accredited school of nursing within 6 months from date of hire, 4. Within 1 year from the date of hire, employee must be enrolled in a BSN program. 5. RNs hired prior to 10/22/2020 are grandfathered in with an Associate Degree in Nursing (ADN) or diploma in nursing, with no further need to obtain a Bachelor's degree in Nursing (BAN or BSN). 6. Chief Nursing Officer must provide approval for any RNs with ADN degree hired after 10/22/2020, based upon unit need. ADN RNs hired after 10/22/2020 must show continued enrolment towards a BSN degree with a signature of contract stipulating a BSN degree must be completed within 3 years of hire, Failure to do so will result in termination. ADN RNS are not eligible for leveling to RN3. Abilities: 1.Work requires the ability to walk throughout the Medical Center and to be standing or walking most of the designated shift. 2.Work requires lifting or carrying objects 35-40lbs. and supporting and positioning patients, some of whom may exceed 300 lbs. 3.The ability to check documents for errors, use a keyboard to enter or retrieve data, and closely examine specimens, images or reports is required. 4.Work conditions include performing procedures where carelessness could result in injury or illness and/or contact with potentially infectious materials and/or strong chemical agents. Responsibilities: 1.Seeks out resources to assist in the management of new patient situations. 2.Uses evidence based guidelines (P&P, nursing standards of care, protocols and pathways) consistently. 3.Supports a hospital wide innovation to achieve positive outcomes. 4.Establishes a caring, therapeutic relationship with patients and families through effective communication, acknowledgement of patient/family perceptions of health and illness and mutual goal setting for optimal outcomes 5.Treats patients and families with respect and a sensitivity for diverse viewpoints and cultures. 6.Maintains positive, professional relationships with all members of the healthcare team. 7.Works effectively with other professional nurses through mutual support and respect. 8.Demonstrates beginning collaboration skills to meet the needs of patients and families. 9.Utilizes beginning assessment skills to evaluate the physical and psychosocial needs of patient/family. 10.Uses scientific and theoretical knowledge to develop and implement the plan of care for assigned patients with support from experienced staff. 11.Recognizes a change in patient status and seeks appropriate resources to address concerns. 12.Uses medical devices safely and effectively in the delivery of patient care and seeks guidance when needed. 13.Demonstrates accountability for implementing policies related to safe and effective administration of medications. 14.Assesses patient safety needs and implements appropriate strategies (fall precautions, infection control, and suicide risk patient identification) to minimize risk and seeks guidance when needed. 15.Applies the teaching-learning process effectively to meet the learning needs of patients and families. 16.Demonstrates accountability for own professional practice, including progress toward achievement of annual goals with guidance. 17.Supports unit goals and change initiatives. 18.Demonstrates beginning delegation skills to meet the needs of patients. 19. Other duties as assigned. Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
NextCure Inc
Beltsville, Maryland
NextCure seeks a highly motivated Vice President, Global Regulatory based in our Beltsville, Maryland offices. The executive will possess global regulatory experience to lead regulatory strategies and filings for our portfolio of first-in-class and best-in-class antibody-drug conjugate (ADC) product candidates. This position reports directly to the Chief Operating Officer. NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville Maryland committed to discovering and developing novel first-in-class and best-in-class therapies to treat cancer. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development. The executive will define and implement innovative regulatory strategies around the globe to expedite development and approval of our ADCs. The executive will formulate the communication strategy and lead interactions with all regulatory authorities, provide strategic regulatory leadership across clinical development and manufacturing activities and provide regulatory guidance throughout the drug development lifecycle to ensure alignment with evolving regulatory requirements and business objectives. The executive also will drive discussion and regulatory decision making with existing partners and with third party vendors, including CROs and CDMOs. This role requires a seasoned executive with in-depth knowledge of US FDA, Health Canada, Europe's EMA, China's NMPA, Japan's PMDA, Australia's TGA, Korea's MFDS, Brazil's ANVISA, India's CDSCO, South Africa's SAHPRA and other international regulatory pathways. In addition, exceptional leadership skills and the ability to collaborate cross-functionally with clinical, manufacturing and research teams will also be required. The successful executive will thrive and adapt to a fast-paced environment focused on global expansion and possess a passion for uniquely positioning ADC therapies. Responsibilities Lead the creation and execution of comprehensive global regulatory strategies for antibody-drug conjugate (ADCs) programs across all phases of product development, including clinical development, manufacturing and commercialization Lead global interactions and discussions with regulatory authorities, from pre-IND stage to final approval and commercializationServe as strategic advisor to executive leadership and cross-functional teams on regulatory risks, opportunities, and timelinesManage cross-department interactions necessary to support regulatory filings for nonclinical pharm tox, manufacturing and clinical activities Prepare and submit all regulatory documents, all associated amendments and supplements, and any other communications to regulatory authorities on a global basisAssess regulatory risks associated with various drug development activities and advise product development teams and/or senior management on possible solutions to mitigate such risksManage interactions, discussions, and decision making with third party vendors, including CROs, CDMOs and any other outside regulatory-related resources, as neededLead regulatory discussion and communication with existing and new strategic partnersProvide due diligence support and advice to business development and licensing colleagues, as neededRepresent the regulatory affairs function in internal and external meetingsProvide strategy and communications surrounding ongoing global regulatory activities and collaborate with project management to drive these activities to completionMaintain up-to-date working knowledge on relevant global regulatory regulations, guidance, and the current regulatory environmentParticipation in due diligence activities and/or reviews of potential licensing candidates Required Education & Experience Advanced degree (PhD, PharmD, MD, or equivalent) in a scientific or regulatory disciplineMinimum of 12 years of experience in regulatory affairs in the biotech or pharmaceutical industry, with at least 8 years in oncology supporting antibody-drug conjugatesProven track record of designing successful global regulatory strategies resulting in product approvals, including Fast Track, NDA, BLA, or MAAIn-depth knowledge of FDA, Health Canada, EMA, NMPA, PMDA, TGA, ANVISA, MFDS, CDSCO, SAHPRA and other international regulatory agencies regulations and guidance documents, with particular attention to issues relating to antibody-drug conjugate developmentOutstanding project management and organizational skills with respect to preparations for major regulatory filings including IND, breakthrough designation, fast frack approval, NDA, BLA, major briefing documents for meetings including End of Phase 1 and Phase 2, Type C and D, and other key interactions with regulatory agencies and other health authorities Strong leadership, strategic thinking and negotiation skillsAbility to thrive in a rapidly changing environment, recommend and implement solutions with a proven ability to collaborate, operate and influence cross-functionally and cross-culturallyExcellent analytical, oral, and written communication skills and stakeholder management abilitiesAbility to multitask and perform in a fast-paced entrepreneurial and growing environment NextCure Inc. is an equal opportunity affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Compensation details: 00 Yearly Salary PIa53c0ff1a8ba-2548
NextCure seeks a highly motivated Vice President, Global Regulatory based in our Beltsville, Maryland offices. The executive will possess global regulatory experience to lead regulatory strategies and filings for our portfolio of first-in-class and best-in-class antibody-drug conjugate (ADC) product candidates. This position reports directly to the Chief Operating Officer. NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville Maryland committed to discovering and developing novel first-in-class and best-in-class therapies to treat cancer. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development. The executive will define and implement innovative regulatory strategies around the globe to expedite development and approval of our ADCs. The executive will formulate the communication strategy and lead interactions with all regulatory authorities, provide strategic regulatory leadership across clinical development and manufacturing activities and provide regulatory guidance throughout the drug development lifecycle to ensure alignment with evolving regulatory requirements and business objectives. The executive also will drive discussion and regulatory decision making with existing partners and with third party vendors, including CROs and CDMOs. This role requires a seasoned executive with in-depth knowledge of US FDA, Health Canada, Europe's EMA, China's NMPA, Japan's PMDA, Australia's TGA, Korea's MFDS, Brazil's ANVISA, India's CDSCO, South Africa's SAHPRA and other international regulatory pathways. In addition, exceptional leadership skills and the ability to collaborate cross-functionally with clinical, manufacturing and research teams will also be required. The successful executive will thrive and adapt to a fast-paced environment focused on global expansion and possess a passion for uniquely positioning ADC therapies. Responsibilities Lead the creation and execution of comprehensive global regulatory strategies for antibody-drug conjugate (ADCs) programs across all phases of product development, including clinical development, manufacturing and commercialization Lead global interactions and discussions with regulatory authorities, from pre-IND stage to final approval and commercializationServe as strategic advisor to executive leadership and cross-functional teams on regulatory risks, opportunities, and timelinesManage cross-department interactions necessary to support regulatory filings for nonclinical pharm tox, manufacturing and clinical activities Prepare and submit all regulatory documents, all associated amendments and supplements, and any other communications to regulatory authorities on a global basisAssess regulatory risks associated with various drug development activities and advise product development teams and/or senior management on possible solutions to mitigate such risksManage interactions, discussions, and decision making with third party vendors, including CROs, CDMOs and any other outside regulatory-related resources, as neededLead regulatory discussion and communication with existing and new strategic partnersProvide due diligence support and advice to business development and licensing colleagues, as neededRepresent the regulatory affairs function in internal and external meetingsProvide strategy and communications surrounding ongoing global regulatory activities and collaborate with project management to drive these activities to completionMaintain up-to-date working knowledge on relevant global regulatory regulations, guidance, and the current regulatory environmentParticipation in due diligence activities and/or reviews of potential licensing candidates Required Education & Experience Advanced degree (PhD, PharmD, MD, or equivalent) in a scientific or regulatory disciplineMinimum of 12 years of experience in regulatory affairs in the biotech or pharmaceutical industry, with at least 8 years in oncology supporting antibody-drug conjugatesProven track record of designing successful global regulatory strategies resulting in product approvals, including Fast Track, NDA, BLA, or MAAIn-depth knowledge of FDA, Health Canada, EMA, NMPA, PMDA, TGA, ANVISA, MFDS, CDSCO, SAHPRA and other international regulatory agencies regulations and guidance documents, with particular attention to issues relating to antibody-drug conjugate developmentOutstanding project management and organizational skills with respect to preparations for major regulatory filings including IND, breakthrough designation, fast frack approval, NDA, BLA, major briefing documents for meetings including End of Phase 1 and Phase 2, Type C and D, and other key interactions with regulatory agencies and other health authorities Strong leadership, strategic thinking and negotiation skillsAbility to thrive in a rapidly changing environment, recommend and implement solutions with a proven ability to collaborate, operate and influence cross-functionally and cross-culturallyExcellent analytical, oral, and written communication skills and stakeholder management abilitiesAbility to multitask and perform in a fast-paced entrepreneurial and growing environment NextCure Inc. is an equal opportunity affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Compensation details: 00 Yearly Salary PIa53c0ff1a8ba-2548
