Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SUMMARY Develop the strategic direction for Global Research QA including activities under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture of solution oriented and evidence-based mind-set with openness for innovative ways of working with new technologies/ Implementing strategic and tactical plans to drive sustainable improvements. Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/ vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP activities being executed at DS cross-functional teams (i.e , Research, Translational Oncology, GDO etc.,). Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions. Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place. Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. Responsibilities Leads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices. Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight. Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies. Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc. Ensures that laboratories and / or vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated. Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders. Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings. Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight. Develop and implement the Research Quality QRB with key partners and collaborators. Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and regulators. Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDA Ensure GLP regulated activities for computer systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being adhered to. Ensure that Clinical Development activities (i.e , protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance. Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation. Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co-lead quality council as necessary. Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization. Allocates and manages financial and human resources within the function. Accountable for performance, progress and success of the team by ensuring that objectives are clear, in place and that teams are managed to drive results. QUALIFICATIONS Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines PhD or other post graduate degree strongly preferred Experience Qualifications Must have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions; broad understanding of global expectations of Health Authorities in the GxP area; profound understanding of the science of product development. Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines. Must have proven expertise within Quality Assurance Research to support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required Must have proven people management experience including experience in a matrix, global environment required Must have strong communications skills, written and oral. Travel Must have the ability to travel up to 20%. Domestic and International travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.
10/03/2024
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SUMMARY Develop the strategic direction for Global Research QA including activities under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture of solution oriented and evidence-based mind-set with openness for innovative ways of working with new technologies/ Implementing strategic and tactical plans to drive sustainable improvements. Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/ vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP activities being executed at DS cross-functional teams (i.e , Research, Translational Oncology, GDO etc.,). Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions. Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place. Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. Responsibilities Leads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices. Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight. Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies. Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc. Ensures that laboratories and / or vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated. Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders. Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings. Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight. Develop and implement the Research Quality QRB with key partners and collaborators. Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and regulators. Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDA Ensure GLP regulated activities for computer systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being adhered to. Ensure that Clinical Development activities (i.e , protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance. Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation. Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co-lead quality council as necessary. Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization. Allocates and manages financial and human resources within the function. Accountable for performance, progress and success of the team by ensuring that objectives are clear, in place and that teams are managed to drive results. QUALIFICATIONS Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines PhD or other post graduate degree strongly preferred Experience Qualifications Must have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions; broad understanding of global expectations of Health Authorities in the GxP area; profound understanding of the science of product development. Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines. Must have proven expertise within Quality Assurance Research to support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required Must have proven people management experience including experience in a matrix, global environment required Must have strong communications skills, written and oral. Travel Must have the ability to travel up to 20%. Domestic and International travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities: Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion. Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams. Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates. Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams. Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking. Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution. Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology. People Management: This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals. Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree in the Life Sciences required Master's Degree Life Sciences preferred Experience Qualifications 4 or More Years relevant working experience in externally sponsored research, including IIS and collaborative studies required 4 or More Years in a clinical management setting required A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required Excellent communication, organizational, and problem-solving skills required Proven people management experience, demonstrating effective leadership and team development preferred Ability to travel up to 10% In-house office position that may require travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.
09/30/2024
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities: Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion. Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams. Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates. Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams. Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking. Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution. Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology. People Management: This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals. Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree in the Life Sciences required Master's Degree Life Sciences preferred Experience Qualifications 4 or More Years relevant working experience in externally sponsored research, including IIS and collaborative studies required 4 or More Years in a clinical management setting required A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required Excellent communication, organizational, and problem-solving skills required Proven people management experience, demonstrating effective leadership and team development preferred Ability to travel up to 10% In-house office position that may require travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.
Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details
09/30/2024
Full time
Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details
Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details
09/30/2024
Full time
Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details
Senior Director, National Field Medical Affairs, Oncology Full-time Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening. The Senior Director, National Field Medical Affairs, Oncology, is responsible for creating, leading, and inspiring a large national Clinical Science Liaison and Genomic Science Liaison teams, focused on enhancing patient outcomes through improved customer engagement. The Senior Director will establish the long-term vision, strategy, plans, objectives and infrastructure across the collective field medical teams. They will form strategic partnerships with Senior Leaders across the organization to create the long-term vision and strategic/tactical plan for regions and individual territories. The Senior Director plays a crucial role in facilitating strong field oncology relationships across the healthcare landscape with external scientific, medical, and patient communities, and is expected to build relationships with key customers through expert peer-to-peer engagements. By maintaining a high-level understanding of customer needs across their network's therapeutic areas at a national level, they are expected to understand and evaluate the organization's opportunities and constraints to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities and build capabilities with an enterprise mindset. In addition to leading and supporting the Field Medical teams, the Senior Director also serves as a Strategic Priority Owner of other Field Medical and broader Guardant Health initiatives. Key Accountabilities Create, lead and set vision, objectives, and goals for the national Field Medical Oncology team in alignment with business needs, in response to the changing healthcare landscape and customer needs, in order to increase customer satisfaction and improve outcomes. Build, inspire, and lead through ambiguity and significant change, as well as with and without specific authority, the Field Medical Oncology team to support the end to end customer experience across regions; identify the right talent as well as provide strategic professional development, mentorship and coaching to facilitate the evolution of the Field Medical team. Maintain effective and regular two-way communication with Sales, Marketing and Medical team partners to create a continuous feedback loop of information and insights to interpret and co-create the medical strategy. Inspire and lead the Field Medical, Oncology team to ensure operation at full potential, consistent delivery above and beyond for customers, patients, and healthcare stakeholders while leveraging Guardant Health capabilities. Work closely with the Medical Affairs leadership to align medical strategies and priorities to be pulled through in the field. Identify resources and tools needed to empower the Field Medical Oncology team to deliver all aspects related to scientific exchange on clinical and Health Economics Outcomes Research data across the entire healthcare landscape. Drive innovation and cross-pollination across GH and Development leadership as a trusted partner to address the evolving clinical data and research needs of HCPs, health systems, researchers, patient groups and other key influencers throughout the healthcare landscape. Key Activities & Responsibilities Create, lead and set vision, objectives, and goals for the Field Medical Oncology team in alignment with Medical Affairs leadership; collaborate across GH national field leaders to ensure consistency and enterprise thinking in strategic priorities. Co-create medical strategy with Marketing, Product and Tech Development to ensure that field-based decisions are aligned with Core Team priorities and needs, and that field medical perspective is embedded in key organizational decisions. Represent the customer voice across Oncology and co-create customer centric solutions with peers in the Medical Affairs leadership to ensure that customer insights are prioritized in network objectives and goals. Proactively communicate and share customer needs, insights and knowledge to senior leadership in order to identify opportunities for collaboration and shape future organization strategies. Build, cultivate and leverage relationships with top tier national thought leaders across the oncology medical and managed care communities; as a field leader, represent the GH voice at national conferences and in executive exchange engagements. Bring innovation and energy as a core member of the Medical Affairs leadership and support VP of Medical Affairs, Oncology in identifying key deliverables, insights, and metrics that demonstrate the value of the Field Medical Oncology organization. Foster team spirit of cross-functional collaboration, enterprise mindset thinking and an ongoing awareness of GH objectives and strategy to deliver on meeting customer needs. Serve as a player/coach to Field Medical Directors and individual contributors through mentorship and acting as an inspirational role model. Collaborate on content and communication of scientific communication with field that includes both clinical and O&E data, and work projects. Lead organizational initiatives and identify individuals to serve on core teams as specific business needs arise. Qualifications: Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.) 15+ years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with extensive experience successfully leading and managing field medical or a customer facing team. Prior experience as a field medical liaison is preferred. Strong understanding of healthcare, legal and regulatory landscape and customer (health systems, payers, providers, etc.) required. Impressive, inspiring and visionary leadership ability with customer-first focus. Strong communication and effective collaboration skills to work across an extremely matrixed stakeholder organization. Embraces an agile mindset to develop necessary processes to get things done. Demonstrated experience with strategic planning, prioritizing and management of high-level initiatives and projects; building and leading teams; coaching and developing others. Strong negotiation skills and ability to influence without authority; excellent problem solving and decision-making skills. Demonstrated evidence of successfully achieving results, delivering high performance and managing a high functioning team of people managers. Ongoing investment in developing self and others to enable others to achieve their potential. Strong work ethic and advancement mindset. Business travel by air or car is required for regular internal and customer facing meetings. Both national and international travel may be required. Role is home office based. May require up to 70% of travel. Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. The US base salary range for this full-time position is $234,600 to $316,700. The range does not include benefits, and if applicable, bonus, commission, or equity. Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to . Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
09/29/2024
Full time
Senior Director, National Field Medical Affairs, Oncology Full-time Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening. The Senior Director, National Field Medical Affairs, Oncology, is responsible for creating, leading, and inspiring a large national Clinical Science Liaison and Genomic Science Liaison teams, focused on enhancing patient outcomes through improved customer engagement. The Senior Director will establish the long-term vision, strategy, plans, objectives and infrastructure across the collective field medical teams. They will form strategic partnerships with Senior Leaders across the organization to create the long-term vision and strategic/tactical plan for regions and individual territories. The Senior Director plays a crucial role in facilitating strong field oncology relationships across the healthcare landscape with external scientific, medical, and patient communities, and is expected to build relationships with key customers through expert peer-to-peer engagements. By maintaining a high-level understanding of customer needs across their network's therapeutic areas at a national level, they are expected to understand and evaluate the organization's opportunities and constraints to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities and build capabilities with an enterprise mindset. In addition to leading and supporting the Field Medical teams, the Senior Director also serves as a Strategic Priority Owner of other Field Medical and broader Guardant Health initiatives. Key Accountabilities Create, lead and set vision, objectives, and goals for the national Field Medical Oncology team in alignment with business needs, in response to the changing healthcare landscape and customer needs, in order to increase customer satisfaction and improve outcomes. Build, inspire, and lead through ambiguity and significant change, as well as with and without specific authority, the Field Medical Oncology team to support the end to end customer experience across regions; identify the right talent as well as provide strategic professional development, mentorship and coaching to facilitate the evolution of the Field Medical team. Maintain effective and regular two-way communication with Sales, Marketing and Medical team partners to create a continuous feedback loop of information and insights to interpret and co-create the medical strategy. Inspire and lead the Field Medical, Oncology team to ensure operation at full potential, consistent delivery above and beyond for customers, patients, and healthcare stakeholders while leveraging Guardant Health capabilities. Work closely with the Medical Affairs leadership to align medical strategies and priorities to be pulled through in the field. Identify resources and tools needed to empower the Field Medical Oncology team to deliver all aspects related to scientific exchange on clinical and Health Economics Outcomes Research data across the entire healthcare landscape. Drive innovation and cross-pollination across GH and Development leadership as a trusted partner to address the evolving clinical data and research needs of HCPs, health systems, researchers, patient groups and other key influencers throughout the healthcare landscape. Key Activities & Responsibilities Create, lead and set vision, objectives, and goals for the Field Medical Oncology team in alignment with Medical Affairs leadership; collaborate across GH national field leaders to ensure consistency and enterprise thinking in strategic priorities. Co-create medical strategy with Marketing, Product and Tech Development to ensure that field-based decisions are aligned with Core Team priorities and needs, and that field medical perspective is embedded in key organizational decisions. Represent the customer voice across Oncology and co-create customer centric solutions with peers in the Medical Affairs leadership to ensure that customer insights are prioritized in network objectives and goals. Proactively communicate and share customer needs, insights and knowledge to senior leadership in order to identify opportunities for collaboration and shape future organization strategies. Build, cultivate and leverage relationships with top tier national thought leaders across the oncology medical and managed care communities; as a field leader, represent the GH voice at national conferences and in executive exchange engagements. Bring innovation and energy as a core member of the Medical Affairs leadership and support VP of Medical Affairs, Oncology in identifying key deliverables, insights, and metrics that demonstrate the value of the Field Medical Oncology organization. Foster team spirit of cross-functional collaboration, enterprise mindset thinking and an ongoing awareness of GH objectives and strategy to deliver on meeting customer needs. Serve as a player/coach to Field Medical Directors and individual contributors through mentorship and acting as an inspirational role model. Collaborate on content and communication of scientific communication with field that includes both clinical and O&E data, and work projects. Lead organizational initiatives and identify individuals to serve on core teams as specific business needs arise. Qualifications: Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.) 15+ years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with extensive experience successfully leading and managing field medical or a customer facing team. Prior experience as a field medical liaison is preferred. Strong understanding of healthcare, legal and regulatory landscape and customer (health systems, payers, providers, etc.) required. Impressive, inspiring and visionary leadership ability with customer-first focus. Strong communication and effective collaboration skills to work across an extremely matrixed stakeholder organization. Embraces an agile mindset to develop necessary processes to get things done. Demonstrated experience with strategic planning, prioritizing and management of high-level initiatives and projects; building and leading teams; coaching and developing others. Strong negotiation skills and ability to influence without authority; excellent problem solving and decision-making skills. Demonstrated evidence of successfully achieving results, delivering high performance and managing a high functioning team of people managers. Ongoing investment in developing self and others to enable others to achieve their potential. Strong work ethic and advancement mindset. Business travel by air or car is required for regular internal and customer facing meetings. Both national and international travel may be required. Role is home office based. May require up to 70% of travel. Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. The US base salary range for this full-time position is $234,600 to $316,700. The range does not include benefits, and if applicable, bonus, commission, or equity. Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to . Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
You will need to login before you can apply for a job. Director of State Affairs (Regional Midwest) About this role We are recruiting four regional Directors of State Affairs to lead BlackRock's advocacy at the state and local level in the United States. Each individual will be responsible for developing, prioritizing, tracking, and communicating BlackRock's public policy priorities at the state and local level for their region. This job posting is for the Director, State Affairs for the Regional Midwest. About the Government Affairs & Public Policy Group BlackRock has a long history of service as a trusted, expert resource to governments and policymakers around the world. Since the Government Affairs & Public Policy team was created in 2009, it has steadily grown, transformed, and established BlackRock as a respected advocate for investors and the millions of retirees we serve. In recent years, that work has extended to long-term challenges such as the retirement crisis, energy security, and investment in critical infrastructure. Key Responsibilities Lead state-level advocacy and engagement with policymakers and regulators. Build and maintain networks of contacts both within BlackRock and externally with state-level policy makers. Identify and monitor key U.S. public policy issues that impact investors at the state and local level; shape BlackRock's position on these issues. Provide technical recommendations legislative and regulatory proposals, collaborating closely with Legal & Compliance and other teams to ensure alignment of views across the firm. Take initiative to define and implement response strategies across states. Work closely with internal stakeholders to understand the interests of BlackRock and our clients as they relate to state-level government affairs developments; involve subject matter experts as appropriate; assist with the development and management of internal working groups. Provide expert level information on priority issues with key stakeholders across the firm. Represent BlackRock's views with trade associations, consultants, and clients. Prepare briefing and presentation materials for engagements with policymakers, regulators, and clients. Write comment letters to policy makers and contribute to thought leadership publications on relevant policy topics. Desired Qualifications Bachelor's degree required. Grassroots organization and campaign experience preferred. 7-10+ years of work experience in state lobbying; financial services expertise preferred. Exceptional communication skills. Must be able to present complex concepts in a concise and understandable way. Demonstrated excellence in written communication. Strong political acumen, thorough understanding of state-level public policy, and ability to be effective with members of both political parties. Ability to work in a fast-paced environment with multiple ongoing deliverables and tight deadlines. Proficiency in PowerPoint, Excel, and Word. Strong research and writing skills; strategic and creative thinking aptitude. Ability to clearly articulate ideas to senior internal and external audiences, including leaders within the firm, outside counsel, clients, and third-party organizations. Excellent collaboration and teambuilding skills. Good judgment and impeccable ethics; desire to succeed in a demanding, innovative, entrepreneurial environment. Exceptional organizational skills and keen attention to detail. Willingness to travel frequently within the U.S. Our benefits To help you stay energized, engaged and inspired, we offer a wide range of benefits including a strong retirement plan, tuition reimbursement, comprehensive healthcare, support for working parents and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about. Our hybrid work model BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock. About BlackRock At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress. This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive. For additional information on BlackRock, please LinkedIn: BlackRock is proud to be an Equal Opportunity and Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, disability, protected veteran status, and other statuses protected by law. BlackRock will consider for employment qualified applicants with arrest or conviction records in a manner consistent with the requirements of the law, including any applicable fair chance law. Create a job alert and receive personalised job recommendations straight to your inbox.
09/26/2024
Full time
You will need to login before you can apply for a job. Director of State Affairs (Regional Midwest) About this role We are recruiting four regional Directors of State Affairs to lead BlackRock's advocacy at the state and local level in the United States. Each individual will be responsible for developing, prioritizing, tracking, and communicating BlackRock's public policy priorities at the state and local level for their region. This job posting is for the Director, State Affairs for the Regional Midwest. About the Government Affairs & Public Policy Group BlackRock has a long history of service as a trusted, expert resource to governments and policymakers around the world. Since the Government Affairs & Public Policy team was created in 2009, it has steadily grown, transformed, and established BlackRock as a respected advocate for investors and the millions of retirees we serve. In recent years, that work has extended to long-term challenges such as the retirement crisis, energy security, and investment in critical infrastructure. Key Responsibilities Lead state-level advocacy and engagement with policymakers and regulators. Build and maintain networks of contacts both within BlackRock and externally with state-level policy makers. Identify and monitor key U.S. public policy issues that impact investors at the state and local level; shape BlackRock's position on these issues. Provide technical recommendations legislative and regulatory proposals, collaborating closely with Legal & Compliance and other teams to ensure alignment of views across the firm. Take initiative to define and implement response strategies across states. Work closely with internal stakeholders to understand the interests of BlackRock and our clients as they relate to state-level government affairs developments; involve subject matter experts as appropriate; assist with the development and management of internal working groups. Provide expert level information on priority issues with key stakeholders across the firm. Represent BlackRock's views with trade associations, consultants, and clients. Prepare briefing and presentation materials for engagements with policymakers, regulators, and clients. Write comment letters to policy makers and contribute to thought leadership publications on relevant policy topics. Desired Qualifications Bachelor's degree required. Grassroots organization and campaign experience preferred. 7-10+ years of work experience in state lobbying; financial services expertise preferred. Exceptional communication skills. Must be able to present complex concepts in a concise and understandable way. Demonstrated excellence in written communication. Strong political acumen, thorough understanding of state-level public policy, and ability to be effective with members of both political parties. Ability to work in a fast-paced environment with multiple ongoing deliverables and tight deadlines. Proficiency in PowerPoint, Excel, and Word. Strong research and writing skills; strategic and creative thinking aptitude. Ability to clearly articulate ideas to senior internal and external audiences, including leaders within the firm, outside counsel, clients, and third-party organizations. Excellent collaboration and teambuilding skills. Good judgment and impeccable ethics; desire to succeed in a demanding, innovative, entrepreneurial environment. Exceptional organizational skills and keen attention to detail. Willingness to travel frequently within the U.S. Our benefits To help you stay energized, engaged and inspired, we offer a wide range of benefits including a strong retirement plan, tuition reimbursement, comprehensive healthcare, support for working parents and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about. Our hybrid work model BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock. About BlackRock At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress. This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive. For additional information on BlackRock, please LinkedIn: BlackRock is proud to be an Equal Opportunity and Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, disability, protected veteran status, and other statuses protected by law. BlackRock will consider for employment qualified applicants with arrest or conviction records in a manner consistent with the requirements of the law, including any applicable fair chance law. Create a job alert and receive personalised job recommendations straight to your inbox.
By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environment where diversity and equity are championed through words and actions. You'll contribute to an innovative culture that is second to none, one that embraces curiosity, discovery and compassion. You'll play a role in something that's never been done before as we integrate science and clinical care to help patients achieve better, faster outcomes - as we Advance Human Ability, together. Job Description Summary Processes all applications from physicians for: 1. Medical staff appointment, clinical privileges and/or reappointment to the SRALAB Medical Staff, including primary source verification 2. Managed care credentialing with companies who contract with SRALAB. 3. Medicare/ Medicaid/IDPH provider numbers (for physicians, nurse practitioners and select allied health staff). Consistently demonstrates support of the SRALAB Statement of Mission and Philosophy by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the Institute. Job Description Distribute applications upon request and establish electronic database file for medical staff members Upon return of application, check for completeness and all required documentation. Analyze information for discrepancy, misstatement, missing data, and time gaps. Enter data into electronic database file. Establish checklist for monitoring and tracking documents in credentials file. Perform primary source verification of information contained in application. This includes on-line electronic/internet sources such as the National Practitioner Data Bank, Office of the Inspector General, and the Illinois Department of Professional Regulations. Analyze credentialing information obtained for compliance with medical staff criteria and qualifications. Discuss key issues and problems to the Credentials Committee and the Senior VP for Medical Affairs. Give completed application to Senior VP for Medical Affairs for his review. Send copies of completed applications to Credentials Committee for review prior to meeting date. Prepare Minutes of meeting for presentation to Medical Executive Committee. Maintain accurate and current credentialing database for medical staff members. Monitor physicians' license and insurance expirations having potential high-risk exposure for SRALAB. Work with physicians to obtain current documentation. Acts as liaison person for managed care credentialing. Processes applications for Medicare/Medicaid/IDPH provider numbers for physicians, nurse practitioners and selected allied health staff members. Collects dues from Active Medical Staff and prepares quarterly treasurer's reports. Assures compliance with accreditation standards (JCAHO/CARF) and regulatory guidelines (state, federal) including Medical Staff Bylaws and policies/procedures. Maintains good working relationship between the SRALAB Medical Staff Office and the other Medical Staff Offices of the McGaw Medical Center (Children's Memorial Hospital, Northwestern Memorial Hospital, Evanston Hospital, NUMS. Other Responsibilities: Enters new physician data into the Meditech user directory, and updates same with any change in physician status. Maintains on-line up-to-date listing of Attending and Consulting Physicians. Maintains Physician Privileges Manuals on all nursing and outpatient floors. Works with Senior VP for Medical Affairs to set up new physician orientation. Prepare Physician Orientation Notebooks for all new Attending Physicians. Answers queries from other hospitals on current and former Attending Physicians and Fellows. Reporting Relationships Reports to the Senior VP for Medical Affairs Knowledge, Skills & Abilities Required Work requires secretarial skills normally acquired through six months or less of formal training, plus two years of college. Bachelor's degree preferred. Work requires two to three years of progressively more responsible clesralabal or secretarial experience and the ability to exercise independent judgement. Interpersonal skills needed in order to interact with key managerial personnel within the hospital and peers within the medical community. Excellent analytical ability needed to prepare reports and documents and to maintain various administrative records. Work frequently produces a high level of mental/visual fatigue while preparing reports, correspondences, etc. Work requires proficient computer skills and knowledge of Windows and Word for Windows in order to run credentialing software Working Conditions Normal office environment with little or no exposure to dust or extreme temperature. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Equal Employment Opportunity ShirleyRyan AbilityLab 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.
09/23/2024
Full time
By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environment where diversity and equity are championed through words and actions. You'll contribute to an innovative culture that is second to none, one that embraces curiosity, discovery and compassion. You'll play a role in something that's never been done before as we integrate science and clinical care to help patients achieve better, faster outcomes - as we Advance Human Ability, together. Job Description Summary Processes all applications from physicians for: 1. Medical staff appointment, clinical privileges and/or reappointment to the SRALAB Medical Staff, including primary source verification 2. Managed care credentialing with companies who contract with SRALAB. 3. Medicare/ Medicaid/IDPH provider numbers (for physicians, nurse practitioners and select allied health staff). Consistently demonstrates support of the SRALAB Statement of Mission and Philosophy by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the Institute. Job Description Distribute applications upon request and establish electronic database file for medical staff members Upon return of application, check for completeness and all required documentation. Analyze information for discrepancy, misstatement, missing data, and time gaps. Enter data into electronic database file. Establish checklist for monitoring and tracking documents in credentials file. Perform primary source verification of information contained in application. This includes on-line electronic/internet sources such as the National Practitioner Data Bank, Office of the Inspector General, and the Illinois Department of Professional Regulations. Analyze credentialing information obtained for compliance with medical staff criteria and qualifications. Discuss key issues and problems to the Credentials Committee and the Senior VP for Medical Affairs. Give completed application to Senior VP for Medical Affairs for his review. Send copies of completed applications to Credentials Committee for review prior to meeting date. Prepare Minutes of meeting for presentation to Medical Executive Committee. Maintain accurate and current credentialing database for medical staff members. Monitor physicians' license and insurance expirations having potential high-risk exposure for SRALAB. Work with physicians to obtain current documentation. Acts as liaison person for managed care credentialing. Processes applications for Medicare/Medicaid/IDPH provider numbers for physicians, nurse practitioners and selected allied health staff members. Collects dues from Active Medical Staff and prepares quarterly treasurer's reports. Assures compliance with accreditation standards (JCAHO/CARF) and regulatory guidelines (state, federal) including Medical Staff Bylaws and policies/procedures. Maintains good working relationship between the SRALAB Medical Staff Office and the other Medical Staff Offices of the McGaw Medical Center (Children's Memorial Hospital, Northwestern Memorial Hospital, Evanston Hospital, NUMS. Other Responsibilities: Enters new physician data into the Meditech user directory, and updates same with any change in physician status. Maintains on-line up-to-date listing of Attending and Consulting Physicians. Maintains Physician Privileges Manuals on all nursing and outpatient floors. Works with Senior VP for Medical Affairs to set up new physician orientation. Prepare Physician Orientation Notebooks for all new Attending Physicians. Answers queries from other hospitals on current and former Attending Physicians and Fellows. Reporting Relationships Reports to the Senior VP for Medical Affairs Knowledge, Skills & Abilities Required Work requires secretarial skills normally acquired through six months or less of formal training, plus two years of college. Bachelor's degree preferred. Work requires two to three years of progressively more responsible clesralabal or secretarial experience and the ability to exercise independent judgement. Interpersonal skills needed in order to interact with key managerial personnel within the hospital and peers within the medical community. Excellent analytical ability needed to prepare reports and documents and to maintain various administrative records. Work frequently produces a high level of mental/visual fatigue while preparing reports, correspondences, etc. Work requires proficient computer skills and knowledge of Windows and Word for Windows in order to run credentialing software Working Conditions Normal office environment with little or no exposure to dust or extreme temperature. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Equal Employment Opportunity ShirleyRyan AbilityLab 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.
Guilford Technical Community College
Jamestown, North Carolina
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
02/27/2022
Full time
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
Spirit of America Federal Credit Union
Lincoln, Nebraska
SPIRIT OF AMERICA FEDERAL CREDIT UNION General Summary: Responsible for Credit Union Accounting Records; Reporting to Government Agencies and Vendors; Liaison to Data Processor; Security; Regulatory Compliance. Credit Union experience (or financial institution) Required for Experience. Responsible for assisting the Credit Union President/C.E.O. in the overall "management" of the Credit Union assets. Essential Functions 1. Assist the President with projects, new services, obtaining bids, and so forth. 2. Ensure that the President is kept fully informed on the conditions and operations of the Credit Union, and of all important factors influencing them. 3. Assist in the development, implementation and maintenance of operational procedures to maximize efficiency and quality of work, and to provide consistent quality service to members. 4. Assume all responsibilities of the Credit Union President/CEO in his/her absence. 5. Prepare or responsible for overseeing the preparation of monthly, quarterly and annual financial and statistical reports for the President and Board of Directors. 6. Prepare for review by President and approval by the Board of Directors the Budget for the Credit Union which is consistent with the overall strategic plan. To implement and oversee the Budget after approval. 7. Security Officer of the Credit Union. 8. Serve as Bank Secrecy Act Compliance Officer, NMLS (National Mortgage Licensing System), responsible for Truth in Savings and other Regulatory compliance. Annual Federal Reserve Report - Reg D - Form 2910a. NMLS (Nationwide Mortgage Licensing System) - Registration for new and renewal of staff and so forth. 9. Ensure that the Credit Union is in compliance with state and federal laws and regulations as established by the National Credit Union Administration (NCUA), the Nebraska Department of Banking and Finance, FFIEC, and other regulatory agencies. 10. Act on Credit Union investments as a member of the Investment Committee. Obtain together information from the various Board approved investment vendors and also direct investments to include the investment maturity ladder for decision making. 11. Assist President in preparing weekly staff meetings. 12. Assist the President with the replenishment and verifying cash for MSR and MSR/Clerk cash drawers. Replenish and verify safe totals with the President or PAR with Supervisory Authority. 13. Balance previous day's business cash to GL balance; Review daily reports - Large Member Checks clearing; Cash transaction register; Override; Undo and Dormant Account reports; Loan maintenance; Make daily cash flow projection; Post Hold files and so forth. 14. Balance Millennium Corporate statements on a weekly basis. 15. Prepare Employee Retirement Plan reporting for 401(k) and Defined Benefit. 16. Responsible for insurance paperwork to include: Maintaining records for life insurance, long term disability, health and dental. Make insurance disbursements and premium collections for health, life and long-term disability including wrap and summary of benefits for employees. 17. Responsible for the Credit Union's Bond and Casualty Insurance to include: questionnaires, reporting and bond claims. Completes CUNA Mutual Group bond renewal with President. 18. Take action on returned NSF checks deposited to member accounts. 19. Prepare quarterly reports for federal withholding, unemployment compensation, etc. 20. Prepare the quarterly Call Report for NCUA. 21. Prepare Annual 945 Report. 22. Attend Board of Director's monthly meetings and take minutes for the Board secretary. 23. Prepare and/or verify employee and vendor annual W-2's, 1099 MISC and so forth for year-end reporting. 24. Seek legal counsel in processing member POA, Trusts, Guardianship and Conservative accounts. In charge of deceased member accounts. Get appropriate documents, contact joint owners, seek legal counsel as needed and so forth. 25. File the unclaimed property report with the State by November 1 each year. 26. Create and maintain employee payroll records including their semi-monthly paystubs. 27. Staff Liaison for the IST Committee - prepares the agenda, research as needed and takes the Committee minutes. 28. Staff Liaison to the Supervisory Committee - prepares the agenda, research as needed and takes the Committee minutes. 29. Staff Liaison to the Delinquency Committee - prepares the agenda, research as needed and takes the Committee minutes. 30. Maintaining vendor contracts and due diligence to include recordkeeping, mailing notices in advance of potential non-renewal (typically six months), sending contracts to legal counsel for review and for opinion to submit to the Board of Directors, etc. 31. Participate in community and business affairs, as necessary, to contribute to the image of the Credit Union. 32. Other duties as assigned by the President. NOTE: The list of essential functions is not exhaustive. It may be supplemented as necessary from time to time. Vice President- Lincoln, NE #Hiring #Lincoln #Nebraska
09/25/2021
Full time
SPIRIT OF AMERICA FEDERAL CREDIT UNION General Summary: Responsible for Credit Union Accounting Records; Reporting to Government Agencies and Vendors; Liaison to Data Processor; Security; Regulatory Compliance. Credit Union experience (or financial institution) Required for Experience. Responsible for assisting the Credit Union President/C.E.O. in the overall "management" of the Credit Union assets. Essential Functions 1. Assist the President with projects, new services, obtaining bids, and so forth. 2. Ensure that the President is kept fully informed on the conditions and operations of the Credit Union, and of all important factors influencing them. 3. Assist in the development, implementation and maintenance of operational procedures to maximize efficiency and quality of work, and to provide consistent quality service to members. 4. Assume all responsibilities of the Credit Union President/CEO in his/her absence. 5. Prepare or responsible for overseeing the preparation of monthly, quarterly and annual financial and statistical reports for the President and Board of Directors. 6. Prepare for review by President and approval by the Board of Directors the Budget for the Credit Union which is consistent with the overall strategic plan. To implement and oversee the Budget after approval. 7. Security Officer of the Credit Union. 8. Serve as Bank Secrecy Act Compliance Officer, NMLS (National Mortgage Licensing System), responsible for Truth in Savings and other Regulatory compliance. Annual Federal Reserve Report - Reg D - Form 2910a. NMLS (Nationwide Mortgage Licensing System) - Registration for new and renewal of staff and so forth. 9. Ensure that the Credit Union is in compliance with state and federal laws and regulations as established by the National Credit Union Administration (NCUA), the Nebraska Department of Banking and Finance, FFIEC, and other regulatory agencies. 10. Act on Credit Union investments as a member of the Investment Committee. Obtain together information from the various Board approved investment vendors and also direct investments to include the investment maturity ladder for decision making. 11. Assist President in preparing weekly staff meetings. 12. Assist the President with the replenishment and verifying cash for MSR and MSR/Clerk cash drawers. Replenish and verify safe totals with the President or PAR with Supervisory Authority. 13. Balance previous day's business cash to GL balance; Review daily reports - Large Member Checks clearing; Cash transaction register; Override; Undo and Dormant Account reports; Loan maintenance; Make daily cash flow projection; Post Hold files and so forth. 14. Balance Millennium Corporate statements on a weekly basis. 15. Prepare Employee Retirement Plan reporting for 401(k) and Defined Benefit. 16. Responsible for insurance paperwork to include: Maintaining records for life insurance, long term disability, health and dental. Make insurance disbursements and premium collections for health, life and long-term disability including wrap and summary of benefits for employees. 17. Responsible for the Credit Union's Bond and Casualty Insurance to include: questionnaires, reporting and bond claims. Completes CUNA Mutual Group bond renewal with President. 18. Take action on returned NSF checks deposited to member accounts. 19. Prepare quarterly reports for federal withholding, unemployment compensation, etc. 20. Prepare the quarterly Call Report for NCUA. 21. Prepare Annual 945 Report. 22. Attend Board of Director's monthly meetings and take minutes for the Board secretary. 23. Prepare and/or verify employee and vendor annual W-2's, 1099 MISC and so forth for year-end reporting. 24. Seek legal counsel in processing member POA, Trusts, Guardianship and Conservative accounts. In charge of deceased member accounts. Get appropriate documents, contact joint owners, seek legal counsel as needed and so forth. 25. File the unclaimed property report with the State by November 1 each year. 26. Create and maintain employee payroll records including their semi-monthly paystubs. 27. Staff Liaison for the IST Committee - prepares the agenda, research as needed and takes the Committee minutes. 28. Staff Liaison to the Supervisory Committee - prepares the agenda, research as needed and takes the Committee minutes. 29. Staff Liaison to the Delinquency Committee - prepares the agenda, research as needed and takes the Committee minutes. 30. Maintaining vendor contracts and due diligence to include recordkeeping, mailing notices in advance of potential non-renewal (typically six months), sending contracts to legal counsel for review and for opinion to submit to the Board of Directors, etc. 31. Participate in community and business affairs, as necessary, to contribute to the image of the Credit Union. 32. Other duties as assigned by the President. NOTE: The list of essential functions is not exhaustive. It may be supplemented as necessary from time to time. Vice President- Lincoln, NE #Hiring #Lincoln #Nebraska
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
09/25/2021
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
09/24/2021
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
09/14/2021
Full time
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
09/11/2021
Full time
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company. Overall Description: The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs. Responsible for preparing and coordinating company responses to queries from health authorities. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals. Responsible for timely compilation of all necessary documents to support regulatory submissions. Ensure cross-functional alignment on regulatory strategies. Qualifications: Bachelor's degree in science or health field required; advance degree is a plus 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs. Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements. Excellent attention to detail and accuracy. Excellent verbal, written, negotiation, and interpersonal communication skills are required.
03/01/2021
Full time
In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company. Overall Description: The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs. Responsible for preparing and coordinating company responses to queries from health authorities. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals. Responsible for timely compilation of all necessary documents to support regulatory submissions. Ensure cross-functional alignment on regulatory strategies. Qualifications: Bachelor's degree in science or health field required; advance degree is a plus 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs. Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements. Excellent attention to detail and accuracy. Excellent verbal, written, negotiation, and interpersonal communication skills are required.
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/31/2021
Full time
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
01/30/2021
Full time
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
Description: Experience in medical device. Has a knowledge of ISO 13485, Medical Device Regulations, More experience with CFR820 med device, help on recall, talking with R&D, speaking with them on daily basis, review validation process, design input, customer input. CE Mark, class 1, looking for class 1 reusable. Need knowledge for CE Mark Will not deal with 510k submission or PMA but may by the end of the year. Daily basis: Help with process validation before it can be signed, rather than director, Tanya, spot-checking, this person will have the first review. Reading over process and then determining whether or not they fall under regulatory requirements. May sit down and work through PMA (Post market surveillance) and work with sales people. collecting data from customers. Regulations: FDA QSR 820, FDA labeling 803, 810, EU ISO3485, 14971 risk management, CE Mark, Computer work is very important. Need to have strong attention to detail Computer programs: Microsoft Office. Skills: regulatory, Medical device, MDR, CFR 820, ISO 13485, CE Mark Top Skills Details: regulatory, MDR, ISO 13485 Additional Skills & Qualifications: BS Degree in Sciences 2-3 years experience in regulatory minimum. 5+ preferred ISO 13485 & FDA QSR 820 Knowledge of CE Marking & the European Medical Device Regulations Knowledge of design control and design history file Experience Level: Intermediate Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/30/2021
Full time
Description: Experience in medical device. Has a knowledge of ISO 13485, Medical Device Regulations, More experience with CFR820 med device, help on recall, talking with R&D, speaking with them on daily basis, review validation process, design input, customer input. CE Mark, class 1, looking for class 1 reusable. Need knowledge for CE Mark Will not deal with 510k submission or PMA but may by the end of the year. Daily basis: Help with process validation before it can be signed, rather than director, Tanya, spot-checking, this person will have the first review. Reading over process and then determining whether or not they fall under regulatory requirements. May sit down and work through PMA (Post market surveillance) and work with sales people. collecting data from customers. Regulations: FDA QSR 820, FDA labeling 803, 810, EU ISO3485, 14971 risk management, CE Mark, Computer work is very important. Need to have strong attention to detail Computer programs: Microsoft Office. Skills: regulatory, Medical device, MDR, CFR 820, ISO 13485, CE Mark Top Skills Details: regulatory, MDR, ISO 13485 Additional Skills & Qualifications: BS Degree in Sciences 2-3 years experience in regulatory minimum. 5+ preferred ISO 13485 & FDA QSR 820 Knowledge of CE Marking & the European Medical Device Regulations Knowledge of design control and design history file Experience Level: Intermediate Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
01/28/2021
Full time
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . • Provides support for tracking and forecasting RQS Ops budget forecasting. • Provides support to the Vendor Management process including management of the end to end invoice process, Administrative Check Requests (ACRs), Vendor Master system, and related activities in financial systems such as Supplier Relationship Management System (SRM) and SalesForce. • Maintains daily support of RQS's financial payments (invoices). Supports and/or facilitates payment solutions for/from RQS staff and external business partners. Receives invoice/payment requests, determines the appropriate compliant solution and facilitates and/or executes payment. Partners with RQS staff, vendors, Finance, Corporate Disbursement Operations (CDO), Iron Mountain, Office of Ethics and Compliance (OEC). • Responsible for suggesting process efficiencies for financial payments process and other team activities to build continuous improvement culture and optimize organization performance • Follows the ARC-Administrative Check Requests process and ensures accuracy. • Monitors and facilitates PO-Purchase Orders progress in Supplier Relationship Management System (SRM) for release of PO number. Submits invoices against PO, Monitors spend on open POs to ensure adequate funds for payment of future invoices. Troubleshoots financial PO challenges elevated by RQS staff and/or vendors. Liaise with Finance on regular basis with focus on process improvement and increased transparency related to payment. • Manages year end accrual process; identifies year-end charges that have not been submitted for payment and accrues against specific budgets as identified. Tracks accruals to ensure completion of payment using accrued funds. • Provides general administrative and transactional activity support to help support RQS Director, Business Services. • Uses multiple systems/software tools (SRM, GEMS/SalesForce, Vendor Master, Magellan, SharePoint) to capture, read analyze and report pertinent data. • Provides back-up support for other business operations roles for coverage during vacations or other circumstances. Qualifications Microsoft Office Proficient, Detail Oriented, Good Written and Verbal Communication, Presentation Skills, Analytical and project management skills, Sharepoint experience preferred. Capability to provide strong customer service preferred. 3.0 minimum GPA Returning to university for at least one semester and graduating within one-year post internship Currently enrolled in university, pursuing a bachelor's degree Demonstrated leadership skills (i.e., extracurricular activities or projects) Authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT may be accommodated if the department can sponsor in a full-time employee capacity) Preferred Majors: Business Administration Communications Computer Science Design Management Operations Management Statistics Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Internship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/28/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . • Provides support for tracking and forecasting RQS Ops budget forecasting. • Provides support to the Vendor Management process including management of the end to end invoice process, Administrative Check Requests (ACRs), Vendor Master system, and related activities in financial systems such as Supplier Relationship Management System (SRM) and SalesForce. • Maintains daily support of RQS's financial payments (invoices). Supports and/or facilitates payment solutions for/from RQS staff and external business partners. Receives invoice/payment requests, determines the appropriate compliant solution and facilitates and/or executes payment. Partners with RQS staff, vendors, Finance, Corporate Disbursement Operations (CDO), Iron Mountain, Office of Ethics and Compliance (OEC). • Responsible for suggesting process efficiencies for financial payments process and other team activities to build continuous improvement culture and optimize organization performance • Follows the ARC-Administrative Check Requests process and ensures accuracy. • Monitors and facilitates PO-Purchase Orders progress in Supplier Relationship Management System (SRM) for release of PO number. Submits invoices against PO, Monitors spend on open POs to ensure adequate funds for payment of future invoices. Troubleshoots financial PO challenges elevated by RQS staff and/or vendors. Liaise with Finance on regular basis with focus on process improvement and increased transparency related to payment. • Manages year end accrual process; identifies year-end charges that have not been submitted for payment and accrues against specific budgets as identified. Tracks accruals to ensure completion of payment using accrued funds. • Provides general administrative and transactional activity support to help support RQS Director, Business Services. • Uses multiple systems/software tools (SRM, GEMS/SalesForce, Vendor Master, Magellan, SharePoint) to capture, read analyze and report pertinent data. • Provides back-up support for other business operations roles for coverage during vacations or other circumstances. Qualifications Microsoft Office Proficient, Detail Oriented, Good Written and Verbal Communication, Presentation Skills, Analytical and project management skills, Sharepoint experience preferred. Capability to provide strong customer service preferred. 3.0 minimum GPA Returning to university for at least one semester and graduating within one-year post internship Currently enrolled in university, pursuing a bachelor's degree Demonstrated leadership skills (i.e., extracurricular activities or projects) Authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT may be accommodated if the department can sponsor in a full-time employee capacity) Preferred Majors: Business Administration Communications Computer Science Design Management Operations Management Statistics Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Internship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Lighthouse Professional Services
Trumbull, Connecticut
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial. Lighthouse Professional Services committed to the success of the companies, candidates, and employees we serve. We invest in excellent working partnerships, powered by people. We are currently seeking a Regulatory Affairs Associate in Trumbull, CT. to work a contract for a client. Position Summary and Special Duties: As a (an) your day-to-day duties will consist of and may not be limited to: The Regulatory Affairs Associate will provide the internal regulatory affairs support for post-marketing of Class I, II and III medical devices. The incumbent will support the registrations and technical files projects for existing and acquired product lines. At the direction of the Sr. Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations. Key Functions: Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations. Identifies, completes, and files all necessary documentation as required for site registrations both domestic and international locations. Assembles, Reviews and updates "Technical Files" for existing and acquired products. Prepares and updates "Declarations of Conformity" as per MDD. Processes and updates CFGs. Supports International Standards Organization implementation and maintenance. Reviews Medical Device Regulatory standards and updates to ensure compliance. Notifies Supervision and Management of Product safety issues. Assists with maintaining and updating Order Entry Restrictions database. Provides liaison with FDA, Notified Body, and Authorized European Reps. Maintains collaborative relationship with R & D, Marketing and Operations is required. Maintains collaborative relationships with external partners including regulators and external OEM suppliers. Performs additional duties as required by management. Qualifications: Bachelor's Degree in Sciences, Engineering, Technical or equivalent. Minimum 3-5 years quality, regulatory, compliance manufacturing, operations and/or engineering is required. Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations. Three - Five years QA/RA experience in the medical device or related industry Additional MDD to EU MDR Transfer Class 1 requirements Tech documentation DETAILS : Duration: 3 months contract Location: Trumbull, CT. Salary: contract role open to hourly rate based on experience Can work remotely. Some people come in 2 days a week as well. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume and salary expectations and any references. Job Requirements: Support regulatory compliance and submissions Filing documents related to regulatory submissions Ensure compliance to existing regulatory submissions Preparing regulatory documents and/or submissions Submit regulatory applications and internal regulatory file documentation Verify compliance with regulatory requirements Ensure compliance with regulatory requirements Assure compliance of regulatory files Providing regulatory and compliance guidance Prepare submissions and reports for regulatory agencies Ensure compliance to regulatory standards Support and ensure regulatory compliance Discuss regulatory issues and submission requirements Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions Maintain regulatory records for regulatory activities and applications Prepare regulatory document submissions and timely submit Review of regulatory quality documents Compile and maintain appropriate technical documents for regulatory submissions Assure global regulatory compliance of company products
01/24/2021
Full time
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial. Lighthouse Professional Services committed to the success of the companies, candidates, and employees we serve. We invest in excellent working partnerships, powered by people. We are currently seeking a Regulatory Affairs Associate in Trumbull, CT. to work a contract for a client. Position Summary and Special Duties: As a (an) your day-to-day duties will consist of and may not be limited to: The Regulatory Affairs Associate will provide the internal regulatory affairs support for post-marketing of Class I, II and III medical devices. The incumbent will support the registrations and technical files projects for existing and acquired product lines. At the direction of the Sr. Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations. Key Functions: Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations. Identifies, completes, and files all necessary documentation as required for site registrations both domestic and international locations. Assembles, Reviews and updates "Technical Files" for existing and acquired products. Prepares and updates "Declarations of Conformity" as per MDD. Processes and updates CFGs. Supports International Standards Organization implementation and maintenance. Reviews Medical Device Regulatory standards and updates to ensure compliance. Notifies Supervision and Management of Product safety issues. Assists with maintaining and updating Order Entry Restrictions database. Provides liaison with FDA, Notified Body, and Authorized European Reps. Maintains collaborative relationship with R & D, Marketing and Operations is required. Maintains collaborative relationships with external partners including regulators and external OEM suppliers. Performs additional duties as required by management. Qualifications: Bachelor's Degree in Sciences, Engineering, Technical or equivalent. Minimum 3-5 years quality, regulatory, compliance manufacturing, operations and/or engineering is required. Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations. Three - Five years QA/RA experience in the medical device or related industry Additional MDD to EU MDR Transfer Class 1 requirements Tech documentation DETAILS : Duration: 3 months contract Location: Trumbull, CT. Salary: contract role open to hourly rate based on experience Can work remotely. Some people come in 2 days a week as well. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume and salary expectations and any references. Job Requirements: Support regulatory compliance and submissions Filing documents related to regulatory submissions Ensure compliance to existing regulatory submissions Preparing regulatory documents and/or submissions Submit regulatory applications and internal regulatory file documentation Verify compliance with regulatory requirements Ensure compliance with regulatory requirements Assure compliance of regulatory files Providing regulatory and compliance guidance Prepare submissions and reports for regulatory agencies Ensure compliance to regulatory standards Support and ensure regulatory compliance Discuss regulatory issues and submission requirements Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions Maintain regulatory records for regulatory activities and applications Prepare regulatory document submissions and timely submit Review of regulatory quality documents Compile and maintain appropriate technical documents for regulatory submissions Assure global regulatory compliance of company products