DESCRIPTION The Vice President for Instruction works closely with College President and leadership team in developing, expanding, and evaluating instructional programs and services throughout the College's service region; supervises the operations of four substantial service locations outside of Moberly, Instructional Technology, Library and Academic Resource Center, as well as Academic Affairs, Workforce Development and Technical Education, Health Sciences, and Student Affairs; assists with strategic planning; ensures that the instructional, student, and/or support services programs reflect the educational philosophy and institutional goals of the College; supports college retention and completion initiatives; coordinates assessment of student learning activities, develops collaborative initiatives with four-year institutions as well as other agencies; provides guidance for the College's Quality Initiative project and other accreditation activities; ensures compliance with mandates of regulatory agencies; and serves as a College representative for community, state, and national events and organizations. This position reports to the College President. MACC offers excellent benefits including health, life, dental, vision, long and short-term disability, accident, critical illness and other insurance options; sick leave, vacation, defined benefit retirement plan through the Public School Retirement System of Missouri; and more. All candidates must submit a completed online application at our website: A cover letter, resume/curriculum vitae, transcripts, and any other relevant documents should be uploaded with the application. Review of applications will begin immediately. QUALIFICATIONS Requirements: Doctorate degree or a master's degree with commitment to terminal degree required. A proven background in successful higher education leadership or related field with at least five years of experience required. Candidates should have strong written and oral communication as well as interpersonal communication skills, demonstrated leadership ability, an understanding of shared governance, a commitment to student success, the ability to manage multiple projects and meet deadlines, experience working with federal and state compliance issues, and a desire to commit to the community college mission. JOB RESPONSIBILITIES The Vice President will assume overall responsibility for the supervision and evaluation of all academic, health sciences, and career and technical programs and personnel, student affairs and student affairs personnel, and other areas as designated by the President. In assuming these responsibilities, the Vice President for Instruction will: Oversee the operations of Academic Affairs, Workforce Development and Technical Education, Health Sciences, Student Affairs, Other Locations, Instructional Technology, and Library and Academic Resource Center; Work with the President in all matters related to instruction and quality of faculty and curriculum, other operations, and student affairs; Work with the Dean of Academic Affairs, Dean of Workforce Development and Technical Education, Dean of Health Sciences, and Site Directors in preparing class schedules and utilizing instructional resources; Work with the Dean of Student Affairs and Enrollment Management regarding the student advisory program and other student support services; Assist with accreditation activities, including serving as the institutional Accreditation Liaison Officer for the Higher Learning Commission when assigned; Review and submit to the President an annual budget for all assigned areas of supervision; Recommend to the President the employment of all certified personnel in assigned areas of supervision; Work with deans to establish and maintain an evaluation system for all academic, health sciences, and workforce development and technical education programs; Conduct research relating to instructional services and facilities in coordination with the deans and site directors; Assume responsibility in cooperation with the instructional deans for determining overload pay and the issuing of contracts; Work with the instructional deans in the acquisition and use of data on community educational and workforce development needs; Work to further establish the College as the cultural and educational center of the community; Approve requisitions for instructional supplies and equipment to be used in assigned areas of supervision; Approve leave requests for personnel in assigned areas of supervision; Ensure compliance with mandates of regulatory agencies pertinent to areas of supervision; Provide leadership for state-level initiatives and activities through MCCA and MDHE, as related to areas of supervision; Develop and provide support for College retention and completion initiatives; Assist with strategic planning and ensure progress is made toward institutional goals; Monitor and revise College policies and procedures for continuous improvement; Serve on the President's Council; Serve as Chair of the Curriculum Committee; Serve as co-Chair of the College Wide Assessment Committee; Assume responsibility for maintaining active professional membership in local, state, and national organizations; Perform other duties as assigned by the President.
03/29/2024
Full time
DESCRIPTION The Vice President for Instruction works closely with College President and leadership team in developing, expanding, and evaluating instructional programs and services throughout the College's service region; supervises the operations of four substantial service locations outside of Moberly, Instructional Technology, Library and Academic Resource Center, as well as Academic Affairs, Workforce Development and Technical Education, Health Sciences, and Student Affairs; assists with strategic planning; ensures that the instructional, student, and/or support services programs reflect the educational philosophy and institutional goals of the College; supports college retention and completion initiatives; coordinates assessment of student learning activities, develops collaborative initiatives with four-year institutions as well as other agencies; provides guidance for the College's Quality Initiative project and other accreditation activities; ensures compliance with mandates of regulatory agencies; and serves as a College representative for community, state, and national events and organizations. This position reports to the College President. MACC offers excellent benefits including health, life, dental, vision, long and short-term disability, accident, critical illness and other insurance options; sick leave, vacation, defined benefit retirement plan through the Public School Retirement System of Missouri; and more. All candidates must submit a completed online application at our website: A cover letter, resume/curriculum vitae, transcripts, and any other relevant documents should be uploaded with the application. Review of applications will begin immediately. QUALIFICATIONS Requirements: Doctorate degree or a master's degree with commitment to terminal degree required. A proven background in successful higher education leadership or related field with at least five years of experience required. Candidates should have strong written and oral communication as well as interpersonal communication skills, demonstrated leadership ability, an understanding of shared governance, a commitment to student success, the ability to manage multiple projects and meet deadlines, experience working with federal and state compliance issues, and a desire to commit to the community college mission. JOB RESPONSIBILITIES The Vice President will assume overall responsibility for the supervision and evaluation of all academic, health sciences, and career and technical programs and personnel, student affairs and student affairs personnel, and other areas as designated by the President. In assuming these responsibilities, the Vice President for Instruction will: Oversee the operations of Academic Affairs, Workforce Development and Technical Education, Health Sciences, Student Affairs, Other Locations, Instructional Technology, and Library and Academic Resource Center; Work with the President in all matters related to instruction and quality of faculty and curriculum, other operations, and student affairs; Work with the Dean of Academic Affairs, Dean of Workforce Development and Technical Education, Dean of Health Sciences, and Site Directors in preparing class schedules and utilizing instructional resources; Work with the Dean of Student Affairs and Enrollment Management regarding the student advisory program and other student support services; Assist with accreditation activities, including serving as the institutional Accreditation Liaison Officer for the Higher Learning Commission when assigned; Review and submit to the President an annual budget for all assigned areas of supervision; Recommend to the President the employment of all certified personnel in assigned areas of supervision; Work with deans to establish and maintain an evaluation system for all academic, health sciences, and workforce development and technical education programs; Conduct research relating to instructional services and facilities in coordination with the deans and site directors; Assume responsibility in cooperation with the instructional deans for determining overload pay and the issuing of contracts; Work with the instructional deans in the acquisition and use of data on community educational and workforce development needs; Work to further establish the College as the cultural and educational center of the community; Approve requisitions for instructional supplies and equipment to be used in assigned areas of supervision; Approve leave requests for personnel in assigned areas of supervision; Ensure compliance with mandates of regulatory agencies pertinent to areas of supervision; Provide leadership for state-level initiatives and activities through MCCA and MDHE, as related to areas of supervision; Develop and provide support for College retention and completion initiatives; Assist with strategic planning and ensure progress is made toward institutional goals; Monitor and revise College policies and procedures for continuous improvement; Serve on the President's Council; Serve as Chair of the Curriculum Committee; Serve as co-Chair of the College Wide Assessment Committee; Assume responsibility for maintaining active professional membership in local, state, and national organizations; Perform other duties as assigned by the President.
Position Summary: We are in search of a dynamic and seasoned Engineering Director to join our team, steering excellence in both engineering and manufacturing processes. Key Responsibilities: Leadership and Strategic Vision: Provide strategic guidance for the engineering department, aligning objectives with broader business goals. Lead and mentor a high-performing engineering team, cultivating a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within specified scope, budget, and timeline. Collaborate seamlessly with cross-functional teams to integrate engineering initiatives across departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements within food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and improve overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to industry regulations, safety standards, and compliance requirements. Collaborate closely with regulatory affairs to stay updated on changes in the food manufacturing industry. Quality Assurance: Establish and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective resource allocation to meet project and organizational objectives. Talent Development: Recruit, train, and nurture engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in engineering or a related field; master's degree preferred. Proven leadership experience in the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
03/28/2024
Full time
Position Summary: We are in search of a dynamic and seasoned Engineering Director to join our team, steering excellence in both engineering and manufacturing processes. Key Responsibilities: Leadership and Strategic Vision: Provide strategic guidance for the engineering department, aligning objectives with broader business goals. Lead and mentor a high-performing engineering team, cultivating a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within specified scope, budget, and timeline. Collaborate seamlessly with cross-functional teams to integrate engineering initiatives across departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements within food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and improve overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to industry regulations, safety standards, and compliance requirements. Collaborate closely with regulatory affairs to stay updated on changes in the food manufacturing industry. Quality Assurance: Establish and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective resource allocation to meet project and organizational objectives. Talent Development: Recruit, train, and nurture engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in engineering or a related field; master's degree preferred. Proven leadership experience in the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
Position Summary: We are in search of a dynamic and seasoned Engineering Director to join our team, steering excellence in both engineering and manufacturing processes. Key Responsibilities: Leadership and Strategic Vision: Provide strategic guidance for the engineering department, aligning objectives with broader business goals. Lead and mentor a high-performing engineering team, cultivating a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within specified scope, budget, and timeline. Collaborate seamlessly with cross-functional teams to integrate engineering initiatives across departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements within food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and improve overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to industry regulations, safety standards, and compliance requirements. Collaborate closely with regulatory affairs to stay updated on changes in the food manufacturing industry. Quality Assurance: Establish and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective resource allocation to meet project and organizational objectives. Talent Development: Recruit, train, and nurture engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in engineering or a related field; master's degree preferred. Proven leadership experience in the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
03/28/2024
Full time
Position Summary: We are in search of a dynamic and seasoned Engineering Director to join our team, steering excellence in both engineering and manufacturing processes. Key Responsibilities: Leadership and Strategic Vision: Provide strategic guidance for the engineering department, aligning objectives with broader business goals. Lead and mentor a high-performing engineering team, cultivating a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within specified scope, budget, and timeline. Collaborate seamlessly with cross-functional teams to integrate engineering initiatives across departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements within food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and improve overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to industry regulations, safety standards, and compliance requirements. Collaborate closely with regulatory affairs to stay updated on changes in the food manufacturing industry. Quality Assurance: Establish and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective resource allocation to meet project and organizational objectives. Talent Development: Recruit, train, and nurture engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in engineering or a related field; master's degree preferred. Proven leadership experience in the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
We are seeking a dynamic and experienced Engineering Director to join our team and drive excellence in our engineering and manufacturing processes. Responsibilities: Leadership and Strategy: Provide strategic direction for the engineering department, aligning with overall business goals and objectives. Lead and mentor a high-performing engineering team, fostering a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within scope, budget, and timeline. Collaborate with cross-functional teams to ensure seamless integration of engineering initiatives with other departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements in the food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and enhance overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to all relevant industry regulations, safety standards, and compliance requirements. Collaborate with regulatory affairs to stay abreast of changes and updates in the food manufacturing industry. Quality Assurance: Implement and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective allocation of resources to meet project and organizational objectives. Talent Development: Recruit, train, and develop engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in Engineering or a related field; Master's degree preferred. Proven experience in a leadership role within the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
03/28/2024
Full time
We are seeking a dynamic and experienced Engineering Director to join our team and drive excellence in our engineering and manufacturing processes. Responsibilities: Leadership and Strategy: Provide strategic direction for the engineering department, aligning with overall business goals and objectives. Lead and mentor a high-performing engineering team, fostering a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within scope, budget, and timeline. Collaborate with cross-functional teams to ensure seamless integration of engineering initiatives with other departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements in the food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and enhance overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to all relevant industry regulations, safety standards, and compliance requirements. Collaborate with regulatory affairs to stay abreast of changes and updates in the food manufacturing industry. Quality Assurance: Implement and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective allocation of resources to meet project and organizational objectives. Talent Development: Recruit, train, and develop engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in Engineering or a related field; Master's degree preferred. Proven experience in a leadership role within the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
Stardom Employment Consultants
Visalia, California
We are seeking a dynamic and experienced Engineering Director to join our team and drive excellence in our engineering and manufacturing processes. Responsibilities: Leadership and Strategy: Provide strategic direction for the engineering department, aligning with overall business goals and objectives. Lead and mentor a high-performing engineering team, fostering a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within scope, budget, and timeline. Collaborate with cross-functional teams to ensure seamless integration of engineering initiatives with other departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements in the food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and enhance overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to all relevant industry regulations, safety standards, and compliance requirements. Collaborate with regulatory affairs to stay abreast of changes and updates in the food manufacturing industry. Quality Assurance: Implement and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective allocation of resources to meet project and organizational objectives. Talent Development: Recruit, train, and develop engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in Engineering or a related field; Master's degree preferred. Proven experience in a leadership role within the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
03/28/2024
Full time
We are seeking a dynamic and experienced Engineering Director to join our team and drive excellence in our engineering and manufacturing processes. Responsibilities: Leadership and Strategy: Provide strategic direction for the engineering department, aligning with overall business goals and objectives. Lead and mentor a high-performing engineering team, fostering a culture of innovation, collaboration, and continuous improvement. Project Management: Oversee the planning, execution, and completion of engineering projects within scope, budget, and timeline. Collaborate with cross-functional teams to ensure seamless integration of engineering initiatives with other departments. Process Optimization: Identify opportunities for process improvements, cost reductions, and efficiency enhancements in the food manufacturing operations. Implement best practices and innovative solutions to optimize production processes and enhance overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to all relevant industry regulations, safety standards, and compliance requirements. Collaborate with regulatory affairs to stay abreast of changes and updates in the food manufacturing industry. Quality Assurance: Implement and maintain robust quality assurance processes to uphold product quality and safety standards. Collaborate with quality control teams to address and resolve any quality-related issues. Budget Management: Develop and manage the engineering department budget, ensuring effective allocation of resources to meet project and organizational objectives. Talent Development: Recruit, train, and develop engineering talent, fostering a culture of learning and professional growth within the team. Conduct regular performance reviews and provide constructive feedback to drive individual and team development. Qualifications: Bachelor's degree in Engineering or a related field; Master's degree preferred. Proven experience in a leadership role within the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and interpersonal skills. Budget management experience. Ability to thrive in a fast-paced, dynamic work environment.
Job Description Purpose: The Scientific Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. Responsibilities: •Develops and executes on US-GAMA FAS TA annual strategy in collaboration with Global TA Head and Head of US GAMA. Proactively initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy. •Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. •Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. As the Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables. •Provides in-house clinical expertise for the assets and disease/condition, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes partnering with Discovery colleagues on the design and implementation of translational strategies. •Acts as a clinical interface and actively solicits opinion through leader interactions related to clinical assets and disease/conditions; partners with Field Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. •May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of medical affairs sponsored or supported clinical research activities. •May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions. •Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease/condition specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. •Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
03/28/2024
Full time
Job Description Purpose: The Scientific Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. Responsibilities: •Develops and executes on US-GAMA FAS TA annual strategy in collaboration with Global TA Head and Head of US GAMA. Proactively initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy. •Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. •Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. As the Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables. •Provides in-house clinical expertise for the assets and disease/condition, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes partnering with Discovery colleagues on the design and implementation of translational strategies. •Acts as a clinical interface and actively solicits opinion through leader interactions related to clinical assets and disease/conditions; partners with Field Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. •May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of medical affairs sponsored or supported clinical research activities. •May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions. •Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease/condition specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. •Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Responsibilities: Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May oversee the work of Assistant/Associate Scientific Directors May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
03/28/2024
Full time
Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Responsibilities: Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May oversee the work of Assistant/Associate Scientific Directors May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
Job Description Purpose: The Director Regulatory Affairs Pharmaceuticals, Facial Aesthetics, is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) and representing Regulatory Affairs on R&D Project teams. Leads the dossier team, GRPT, and LRST for assigned projects. Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. Serves as the primary regulatory interface with AST, IEST and other supporting teams. Proactively anticipates and mitigates regulatory risks. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy and e nsures compliance with global regulatory requirements. Manages compounds through all phases of development, including pre-Phase 1, post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies, commitments, and obligations in compliance with regulations and company policies and procedures. Ensures alignment of global regulatory strategies with Sr. management. Demonstrates leadership behaviors consistent with level, including operating with minimal guidance. May cover multiple developmental projects. May participate in initiatives. May have direct reports. Responsibilities: Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests . Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders . Acts independently under the direction of a Sr Director. May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members. Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance committees with partnered assets. Provides informed regulatory opinion based on experience and expertise. Independently leads governance discussions, including representing cross-functional points of view and presents at other governance forums including APGB, CFG, Toxin Board and Toxin Office. Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services). Chairs or sponsors key regulatory initiatives and presents outcomes to Regulatory leadership team. Provides leadership and development to direct reports.
03/28/2024
Full time
Job Description Purpose: The Director Regulatory Affairs Pharmaceuticals, Facial Aesthetics, is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) and representing Regulatory Affairs on R&D Project teams. Leads the dossier team, GRPT, and LRST for assigned projects. Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. Serves as the primary regulatory interface with AST, IEST and other supporting teams. Proactively anticipates and mitigates regulatory risks. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy and e nsures compliance with global regulatory requirements. Manages compounds through all phases of development, including pre-Phase 1, post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies, commitments, and obligations in compliance with regulations and company policies and procedures. Ensures alignment of global regulatory strategies with Sr. management. Demonstrates leadership behaviors consistent with level, including operating with minimal guidance. May cover multiple developmental projects. May participate in initiatives. May have direct reports. Responsibilities: Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests . Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders . Acts independently under the direction of a Sr Director. May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members. Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance committees with partnered assets. Provides informed regulatory opinion based on experience and expertise. Independently leads governance discussions, including representing cross-functional points of view and presents at other governance forums including APGB, CFG, Toxin Board and Toxin Office. Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services). Chairs or sponsors key regulatory initiatives and presents outcomes to Regulatory leadership team. Provides leadership and development to direct reports.
Job Description The Associate Director, Business Unit Communications and Public Affairs - Gastroenterology is an opportunity for an entrepreneurial-minded, media savvy, passionate communicator to lead the strategy and execution of all external communications programs that advance AbbVie's award-winning gastroenterology portfolio. The Associate Director must be a strategic thinker and execute flawlessly while managing a broad range of internal and external stakeholders across mid-to-high levels of management. The Associate Director reports to the Director, Business Unit Communications and Public Affairs, Immunology. This role collaborates with functions across the organization, including Commercial Leadership, Medical Affairs, Regulatory Affairs, Corporate Communications, Research and Development Communications, and International Public Affairs colleagues to identify and maximize opportunities. RESPONSIBILITIES Develops strategic, high-impact public affairs programs to advance business objectives with emphasis on competitive differentiation, analytics, and the external environment. Secures timely buy-in and input from functional and franchise leaders on Public Affairs programs, including securing budget to effectively execute programs. Oversees and implements tactical program elements, ensuring deliverables are met on time and on budget across paid, earned, shared, and owned channels. Serves as communications advisor to franchise, ensuring programs are creatively developed and executed with the external environment in mind. Represents Business Unit Communications and Public Affairs on Integrated Brand Teams and proactively contributes to decision making settings with cross-functional business partners. Develops and maintains relationships on behalf of AbbVie with patient advocates and advocacy organizations. Demonstrates strong understanding of U.S. media environment and has media relations experience and skills to ensure effective engagement with reporters. Manages issues that affect the business overall by proactively anticipating and mitigating reputational risk to AbbVie and immunology brands. Drives agency partner performance and ensures effective use of AbbVie resources. Ensures compliance by managing review process for external communications materials (press releases, statements, response documents, fact sheets, etc.). Keep various parties apprised of status, timelines, and directional shifts to ensure smooth review process and to meet corporate deadlines. Consistently shares best practices and offers new ideas and thoughts to raise the bar for the Business Unit Communications team.
03/28/2024
Full time
Job Description The Associate Director, Business Unit Communications and Public Affairs - Gastroenterology is an opportunity for an entrepreneurial-minded, media savvy, passionate communicator to lead the strategy and execution of all external communications programs that advance AbbVie's award-winning gastroenterology portfolio. The Associate Director must be a strategic thinker and execute flawlessly while managing a broad range of internal and external stakeholders across mid-to-high levels of management. The Associate Director reports to the Director, Business Unit Communications and Public Affairs, Immunology. This role collaborates with functions across the organization, including Commercial Leadership, Medical Affairs, Regulatory Affairs, Corporate Communications, Research and Development Communications, and International Public Affairs colleagues to identify and maximize opportunities. RESPONSIBILITIES Develops strategic, high-impact public affairs programs to advance business objectives with emphasis on competitive differentiation, analytics, and the external environment. Secures timely buy-in and input from functional and franchise leaders on Public Affairs programs, including securing budget to effectively execute programs. Oversees and implements tactical program elements, ensuring deliverables are met on time and on budget across paid, earned, shared, and owned channels. Serves as communications advisor to franchise, ensuring programs are creatively developed and executed with the external environment in mind. Represents Business Unit Communications and Public Affairs on Integrated Brand Teams and proactively contributes to decision making settings with cross-functional business partners. Develops and maintains relationships on behalf of AbbVie with patient advocates and advocacy organizations. Demonstrates strong understanding of U.S. media environment and has media relations experience and skills to ensure effective engagement with reporters. Manages issues that affect the business overall by proactively anticipating and mitigating reputational risk to AbbVie and immunology brands. Drives agency partner performance and ensures effective use of AbbVie resources. Ensures compliance by managing review process for external communications materials (press releases, statements, response documents, fact sheets, etc.). Keep various parties apprised of status, timelines, and directional shifts to ensure smooth review process and to meet corporate deadlines. Consistently shares best practices and offers new ideas and thoughts to raise the bar for the Business Unit Communications team.
Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, delivering scientific communications and driving results. This position can be based out of Irvine, CA or Marlow, UK. What Your New Manager Wants You To Know The Associate Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the GAMA organization. Working under the leadership of the Executive Medical Director, Global Body Contouring, GAMA in partnership with key medical functional teams; the Associate Director / Director will assist in the development and implementation of comprehensive medical strategies for specific medical devices / products within the Body Contouring aesthetics portfolio. The Associate Director / Director must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regional regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. YOU ARE more than just a title, YOU ARE A global strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Strategic and Tactical Planning Develop and implement GAMA Global Body Contouring strategic and tactical plans. P articipate in pre-launch, launch and post-launch strategic decisions and delivery of medical tactics alongside providing medical expertise and scientific support to cross functional stakeholders. Measure and communicate progress on medical project milestones. Ensure alignment of medical functional teams supporting the Global Body Contouring strategic and tactical plans. Provide TA specific strategic guidance to the Global Body Contouring Medical Science Liaisons (MSLs). Lead on planning for and execution of medical advisory boards to inform current and future Allergan Aesthetic / AbbVie Medical Aesthetic strategic decisions. Contribute to commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment. Advice and support commercial colleagues in the development of their marketing plans and scientific materials. Medical and Scientific Data Generation and Communication Under guidance from GAMA leadership, help develop and execute data generation plans (e.g. Phase 4) to provide post marketing data that supports the Body Contouring portfolio. Collaborate with the Global Scientific Communications team to contribute to robust Body Contouring publication plans. Collaborate with GAMA team members to identify key scientific content needed for field MSL teams. Internal and External Relationships Establish and maintain internal organizational links with the broader R&D, commercial and other Allergan Aesthetics / AbbVie departments to ensure appropriate support for GAMA. Establish and maintain relationships with top tier external experts in aesthetics to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure external expert development and communication is optimized. Collaborate with Health Economic and Outcomes Research (HEOR) team to establish scientific and clinical credibility for clinical outcomes focused on patient reported outcomes. Assess support of external IIS proposals and concepts related to Body Contouring to ensure alignment with IIS priorities. Deliver portfolio-related clinical presentations as needed and participate in prioritized scientific congresses. Collect HCP and MSL insights to inform Allergan Aesthetics / AbbVie strategy (e.g. via advisory boards, strategic insights, field insight discussions).
03/28/2024
Full time
Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, delivering scientific communications and driving results. This position can be based out of Irvine, CA or Marlow, UK. What Your New Manager Wants You To Know The Associate Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the GAMA organization. Working under the leadership of the Executive Medical Director, Global Body Contouring, GAMA in partnership with key medical functional teams; the Associate Director / Director will assist in the development and implementation of comprehensive medical strategies for specific medical devices / products within the Body Contouring aesthetics portfolio. The Associate Director / Director must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regional regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. YOU ARE more than just a title, YOU ARE A global strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Strategic and Tactical Planning Develop and implement GAMA Global Body Contouring strategic and tactical plans. P articipate in pre-launch, launch and post-launch strategic decisions and delivery of medical tactics alongside providing medical expertise and scientific support to cross functional stakeholders. Measure and communicate progress on medical project milestones. Ensure alignment of medical functional teams supporting the Global Body Contouring strategic and tactical plans. Provide TA specific strategic guidance to the Global Body Contouring Medical Science Liaisons (MSLs). Lead on planning for and execution of medical advisory boards to inform current and future Allergan Aesthetic / AbbVie Medical Aesthetic strategic decisions. Contribute to commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment. Advice and support commercial colleagues in the development of their marketing plans and scientific materials. Medical and Scientific Data Generation and Communication Under guidance from GAMA leadership, help develop and execute data generation plans (e.g. Phase 4) to provide post marketing data that supports the Body Contouring portfolio. Collaborate with the Global Scientific Communications team to contribute to robust Body Contouring publication plans. Collaborate with GAMA team members to identify key scientific content needed for field MSL teams. Internal and External Relationships Establish and maintain internal organizational links with the broader R&D, commercial and other Allergan Aesthetics / AbbVie departments to ensure appropriate support for GAMA. Establish and maintain relationships with top tier external experts in aesthetics to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure external expert development and communication is optimized. Collaborate with Health Economic and Outcomes Research (HEOR) team to establish scientific and clinical credibility for clinical outcomes focused on patient reported outcomes. Assess support of external IIS proposals and concepts related to Body Contouring to ensure alignment with IIS priorities. Deliver portfolio-related clinical presentations as needed and participate in prioritized scientific congresses. Collect HCP and MSL insights to inform Allergan Aesthetics / AbbVie strategy (e.g. via advisory boards, strategic insights, field insight discussions).
Job Description The Director Regulatory Affairs, US & Canada, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. Responsibilities: Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests. Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders. Acts independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership,of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services). Chairs or sponsor key GRS initiatives and presents outcomes to RA LT. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
03/27/2024
Full time
Job Description The Director Regulatory Affairs, US & Canada, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. Responsibilities: Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests. Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders. Acts independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership,of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services). Chairs or sponsor key GRS initiatives and presents outcomes to RA LT. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
Imagine doing the best work of your career in a place where your efforts advance lives and empower communities. Where a shared passion for education and student achievement guides every decision. That's what awaits when you join the High School Equivalency Academy team. Get ready to transform futures, including your own. How You Can Impact: As the Executive Director of the High School Equivalency (HSE) Academy, nonprofit organization dedicated to impacting the lives of non-high school graduates in our communities, you will plan, organize, and lead HSE program operations in accordance with all applicable regulatory, governmental, and accreditation requirements. Provide leadership in the administration of the policies and procedures for new student enrollments, student retention, HSE matriculations, and educational/support staff. Manage the operations, budget, and performance objectives to ensure achievement of Foundation and program goals. Serves as a member of the Leadership Team for strategic planning, fiscal management, resource development, community relations, and policy setting. Leads, plans, directs, and administers the HSE Academy Program's annual goals and objectives, and budgets for four campus' operations. Develops and executes a plan that implements HSE Academy Program-wide strategic initiatives for the instructional program, student support services, staff development, and facilities. Works collaboratively with the Executive Director, Philanthropy and the Director, Foundations and Community Relations to develop public awareness, and partnerships, and support philanthropic endeavors within the communities. Ensures the HSE Academy program meets projected enrollment, attendance, completion, awarding of HSE certificate of passing, and program performance goals. Responsible for collaborative communications with campus and administration leadership to provide a summary of the progressions and trends of the HSE Academy student population and faculty. Oversees HSE Academy faculty and ensures tracking of HSE Academy student progress, tracking of Personal Responsibility Plan (PRP) student progress, and monitoring of testing at each campus. Who You Are: The ideal candidate has a minimum of three to five years' experience in an administrative level position with appropriate/equivalent industry concerned with academic and career development administration, practices and services, and fiscal and operations management. Minimum three to five years progressive leadership experience in post-secondary education or high school equivalency operations. Recent experience in campus operations preferred. Two years of management experience. Nonprofit management experience preferred. One year of admissions experience in post-secondary education preferred. Knowledge of official HSE testing procedures including eligibility requirements, test development, measurement principles, and methods. Experience with a Student Information System (SIS) and Customer Relationship Management (CRM) system preferred. Bachelor's degree in education, business administration, student affairs, or related field required. About HSE Academy: HSE Academy serves the primary mission of the American Career College Educational Foundation (ACCEF), a 501(c)(3) nonprofit with the roots that go back more than 20 years, to provide learning that elevates the lives of non-high school graduates by helping them earn their high school certificate. We are solely dedicated to helping prepare students to successfully pass the California High School Equivalency Test (HiSET), which includes five tests over two days in writing, social studies, science, mathematics and reading. HSE Academy offers a high-quality preparation and testing program at no cost to our students, with live and virtual classes provided three times per day to accommodate students' work and family schedules. Through our HSE Academy and scholarship support, we offer a second chance to help students expand their career options or higher education opportunities. The program is offered online and at campus locations in Anaheim, Los Angeles, Ontario, and Santa Ana. Campus: Administration Irvine Function: Administrative
03/25/2024
Full time
Imagine doing the best work of your career in a place where your efforts advance lives and empower communities. Where a shared passion for education and student achievement guides every decision. That's what awaits when you join the High School Equivalency Academy team. Get ready to transform futures, including your own. How You Can Impact: As the Executive Director of the High School Equivalency (HSE) Academy, nonprofit organization dedicated to impacting the lives of non-high school graduates in our communities, you will plan, organize, and lead HSE program operations in accordance with all applicable regulatory, governmental, and accreditation requirements. Provide leadership in the administration of the policies and procedures for new student enrollments, student retention, HSE matriculations, and educational/support staff. Manage the operations, budget, and performance objectives to ensure achievement of Foundation and program goals. Serves as a member of the Leadership Team for strategic planning, fiscal management, resource development, community relations, and policy setting. Leads, plans, directs, and administers the HSE Academy Program's annual goals and objectives, and budgets for four campus' operations. Develops and executes a plan that implements HSE Academy Program-wide strategic initiatives for the instructional program, student support services, staff development, and facilities. Works collaboratively with the Executive Director, Philanthropy and the Director, Foundations and Community Relations to develop public awareness, and partnerships, and support philanthropic endeavors within the communities. Ensures the HSE Academy program meets projected enrollment, attendance, completion, awarding of HSE certificate of passing, and program performance goals. Responsible for collaborative communications with campus and administration leadership to provide a summary of the progressions and trends of the HSE Academy student population and faculty. Oversees HSE Academy faculty and ensures tracking of HSE Academy student progress, tracking of Personal Responsibility Plan (PRP) student progress, and monitoring of testing at each campus. Who You Are: The ideal candidate has a minimum of three to five years' experience in an administrative level position with appropriate/equivalent industry concerned with academic and career development administration, practices and services, and fiscal and operations management. Minimum three to five years progressive leadership experience in post-secondary education or high school equivalency operations. Recent experience in campus operations preferred. Two years of management experience. Nonprofit management experience preferred. One year of admissions experience in post-secondary education preferred. Knowledge of official HSE testing procedures including eligibility requirements, test development, measurement principles, and methods. Experience with a Student Information System (SIS) and Customer Relationship Management (CRM) system preferred. Bachelor's degree in education, business administration, student affairs, or related field required. About HSE Academy: HSE Academy serves the primary mission of the American Career College Educational Foundation (ACCEF), a 501(c)(3) nonprofit with the roots that go back more than 20 years, to provide learning that elevates the lives of non-high school graduates by helping them earn their high school certificate. We are solely dedicated to helping prepare students to successfully pass the California High School Equivalency Test (HiSET), which includes five tests over two days in writing, social studies, science, mathematics and reading. HSE Academy offers a high-quality preparation and testing program at no cost to our students, with live and virtual classes provided three times per day to accommodate students' work and family schedules. Through our HSE Academy and scholarship support, we offer a second chance to help students expand their career options or higher education opportunities. The program is offered online and at campus locations in Anaheim, Los Angeles, Ontario, and Santa Ana. Campus: Administration Irvine Function: Administrative
Job Description Provides specialist medical/scientific strategic and operational leadership into global oncology pipeline related medical affairs activities including but not limited to; medical and scientific strategies for the therapeutic franchise and/or multiple assets/indications, deep therapeutic area and treatment data and insights synthesis, external expert and provider interactions, generation of clinical and scientific data (enhancing therapeutic benefit, unmet medical need and added value to standards of care for patients); internal and external educational initiatives (medical education, data, guidelines and scientific communications and training). Develops and maintains professional relationships with External Experts, develops innovative research concepts aligned to evidence gaps for clinical data generation. Works cross functionally within the pipeline commercialization matrix to provide strategic medical and scientific leadership and partnership into asset strategies. Operates in alignment with AbbVie's business code of conduct, policies and all applicable laws and regulations. Responsibilities: Leads a team of 3-4 global pipeline scientific/ medical directors. Leads and partners on the development of multiple oncology asset strategies within the pipeline and strategic governance frameworks. Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline scientific strategy. Builds and shapes the Pipeline Scientific Communication Strategy for multiple assets. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, commercial, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Establishes and approves scientific methods for hypotheses, rational, design of protocols and their reports across different products. Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. May act as scientific leader for several programs within an area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. Develop scientifically accurate materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
03/20/2024
Full time
Job Description Provides specialist medical/scientific strategic and operational leadership into global oncology pipeline related medical affairs activities including but not limited to; medical and scientific strategies for the therapeutic franchise and/or multiple assets/indications, deep therapeutic area and treatment data and insights synthesis, external expert and provider interactions, generation of clinical and scientific data (enhancing therapeutic benefit, unmet medical need and added value to standards of care for patients); internal and external educational initiatives (medical education, data, guidelines and scientific communications and training). Develops and maintains professional relationships with External Experts, develops innovative research concepts aligned to evidence gaps for clinical data generation. Works cross functionally within the pipeline commercialization matrix to provide strategic medical and scientific leadership and partnership into asset strategies. Operates in alignment with AbbVie's business code of conduct, policies and all applicable laws and regulations. Responsibilities: Leads a team of 3-4 global pipeline scientific/ medical directors. Leads and partners on the development of multiple oncology asset strategies within the pipeline and strategic governance frameworks. Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline scientific strategy. Builds and shapes the Pipeline Scientific Communication Strategy for multiple assets. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, commercial, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Establishes and approves scientific methods for hypotheses, rational, design of protocols and their reports across different products. Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. May act as scientific leader for several programs within an area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. Develop scientifically accurate materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/26/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/25/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
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.
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
09/12/2021
Full time
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details