Job Title: Sr. Director, Global Market Access and Pricing Lead - Oncology Location: Cambridge, MA About the Job Sanofi Genzyme's Oncology franchise has a diverse and fast-growing portfolio. This includes the late-stage launching assets (Sarclisa / isatuximab / anti-CD38) in multiple myeloma, as well as earlier compounds in oncology. We are rapidly advancing a robust and reinvigorated oncology pipeline in different malignancies including colorectal and other GI cancers, lung cancers, and hematology. Oncology is at the forefront of the key issues hence leadership in access policy is critical for Sanofi success and support timely access. We are navigating in an uncertain and evolving environment, where different structural access hurdles have been identified/prioritized. Market Access is central to guiding cross-functional efforts to mitigate access-related risks, and prepare for pipeline future launches . The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing strategy, plans and tactics for the hematology and solid tumor pipeline through best-in-class methodologies. Main areas of focus will be as follows: Lead all relevant strategic and tactical activities to support the Market Access inputs to the pipeline assets strategy (landscaping, payer requirements, value positioning, pricing/access assumptions ) Lead cross-brand projects as part of the Access policy workforce, in collaboration with other functions (e.g., combinations challenges, alternative endpoints, etc.) This is a highly collaborative role which will coordinate the relevant cross-functional projects and that must work cohesively with all relevant stakeholders within Market Access (HEVA, GMAX CoE, Affiliates ) and beyond (Commercial, Clinical, Medical, Biostats etc ) to build successful access and pricing strategies, plan and tools in order to realize the full pricing and access potential of Sanofi solutions. The role will report to the Global Head of Market Access & Pricing - Oncology . The position will provide exposure to pre-POC, post-PoC and pre-launch activities. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: As per task / indication / asset, the incumbent will lead the efforts according to needs, priorities and ramp-up. Increasing autonomy expected to grow over time. Collaborates to the development and supports execution of the access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (e.g. Commercial, Clinical, medical, regulatory etc.) Partner effectively with relevant departments (e.g. Commercial, Clinical Development, Regulatory Affairs, Medical Affairs, HEOR ) to influence the market assessment, product positioning, and TPP by providing strategic input regarding market access, reimbursement and pricing information throughout the product life cycle. For each indications / asset under scope, responsible for the timely execution of assigned activities pertaining to the following areas (lead or support as per cases), such as: Foundational knowledge of disease and payer unmet need Competitive assessment Early market access success factors / risks identification Fact based early potential assessments (price/access assumptions for forecasting) and scenario development Informed market access input to development plan & pivotal trial design Coordinates the relevant Market Access cross-functional working groups / sub-team / projects ensuring relevant input / engagement from key markets Develops and maintains a high level of knowledge with regards to the scientific, clinical, strategic pricing and commercial developments relevant to the assets/indications under scope Develops and maintains a robust understanding of relevant pricing and reimbursement criteria used by payers in key markets to make informed decisions about payer strategy, plans and tactics About You SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Minimum 10 years of demonstrated professional experience with a proven track record in Global Market Access. Experience in US market dynamics, Health Economics and Outcomes Research (HEOR), and healthcare policy is highly valued. Demonstrated global access launch leadership experience Demonstrated business acumen, analytical and financial skills to evaluate investment strategies, comfortable with product forecast and P&L Demonstrated ability to leverage research, scenario analyses and payor and pricing insights to generate global integrated market access payer and pricing strategies and plans to maximize product differentiation most relevant to payers Demonstrated ability to effectively engage with a diverse group of leaders across within a matrix organization; demonstrated ability to influence and lead without direct reporting relationships. Strong organizational and project management skills, demonstrated ability to successfully drive a project to completion with positive results Demonstrated understanding of how the customer perceives their own business / institutional mandate relative to competition, understands customer's needs, culture, and how things get done in the customer environment Sound grounding in HEOR (modeling, comparative data, data generation, RWE ) to allow efficient and synergistic partnership Oncology background highly preferred Significant experience / exposure to clinical development Team management experience KEY WORKING RELATIONSHIPS Regular, close contact with: GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) HEVA leads Major Local Market Access leads, franchise and medical heads Market Access CoEs / GTMC Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
09/03/2025
Full time
Job Title: Sr. Director, Global Market Access and Pricing Lead - Oncology Location: Cambridge, MA About the Job Sanofi Genzyme's Oncology franchise has a diverse and fast-growing portfolio. This includes the late-stage launching assets (Sarclisa / isatuximab / anti-CD38) in multiple myeloma, as well as earlier compounds in oncology. We are rapidly advancing a robust and reinvigorated oncology pipeline in different malignancies including colorectal and other GI cancers, lung cancers, and hematology. Oncology is at the forefront of the key issues hence leadership in access policy is critical for Sanofi success and support timely access. We are navigating in an uncertain and evolving environment, where different structural access hurdles have been identified/prioritized. Market Access is central to guiding cross-functional efforts to mitigate access-related risks, and prepare for pipeline future launches . The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing strategy, plans and tactics for the hematology and solid tumor pipeline through best-in-class methodologies. Main areas of focus will be as follows: Lead all relevant strategic and tactical activities to support the Market Access inputs to the pipeline assets strategy (landscaping, payer requirements, value positioning, pricing/access assumptions ) Lead cross-brand projects as part of the Access policy workforce, in collaboration with other functions (e.g., combinations challenges, alternative endpoints, etc.) This is a highly collaborative role which will coordinate the relevant cross-functional projects and that must work cohesively with all relevant stakeholders within Market Access (HEVA, GMAX CoE, Affiliates ) and beyond (Commercial, Clinical, Medical, Biostats etc ) to build successful access and pricing strategies, plan and tools in order to realize the full pricing and access potential of Sanofi solutions. The role will report to the Global Head of Market Access & Pricing - Oncology . The position will provide exposure to pre-POC, post-PoC and pre-launch activities. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: As per task / indication / asset, the incumbent will lead the efforts according to needs, priorities and ramp-up. Increasing autonomy expected to grow over time. Collaborates to the development and supports execution of the access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (e.g. Commercial, Clinical, medical, regulatory etc.) Partner effectively with relevant departments (e.g. Commercial, Clinical Development, Regulatory Affairs, Medical Affairs, HEOR ) to influence the market assessment, product positioning, and TPP by providing strategic input regarding market access, reimbursement and pricing information throughout the product life cycle. For each indications / asset under scope, responsible for the timely execution of assigned activities pertaining to the following areas (lead or support as per cases), such as: Foundational knowledge of disease and payer unmet need Competitive assessment Early market access success factors / risks identification Fact based early potential assessments (price/access assumptions for forecasting) and scenario development Informed market access input to development plan & pivotal trial design Coordinates the relevant Market Access cross-functional working groups / sub-team / projects ensuring relevant input / engagement from key markets Develops and maintains a high level of knowledge with regards to the scientific, clinical, strategic pricing and commercial developments relevant to the assets/indications under scope Develops and maintains a robust understanding of relevant pricing and reimbursement criteria used by payers in key markets to make informed decisions about payer strategy, plans and tactics About You SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Minimum 10 years of demonstrated professional experience with a proven track record in Global Market Access. Experience in US market dynamics, Health Economics and Outcomes Research (HEOR), and healthcare policy is highly valued. Demonstrated global access launch leadership experience Demonstrated business acumen, analytical and financial skills to evaluate investment strategies, comfortable with product forecast and P&L Demonstrated ability to leverage research, scenario analyses and payor and pricing insights to generate global integrated market access payer and pricing strategies and plans to maximize product differentiation most relevant to payers Demonstrated ability to effectively engage with a diverse group of leaders across within a matrix organization; demonstrated ability to influence and lead without direct reporting relationships. Strong organizational and project management skills, demonstrated ability to successfully drive a project to completion with positive results Demonstrated understanding of how the customer perceives their own business / institutional mandate relative to competition, understands customer's needs, culture, and how things get done in the customer environment Sound grounding in HEOR (modeling, comparative data, data generation, RWE ) to allow efficient and synergistic partnership Oncology background highly preferred Significant experience / exposure to clinical development Team management experience KEY WORKING RELATIONSHIPS Regular, close contact with: GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) HEVA leads Major Local Market Access leads, franchise and medical heads Market Access CoEs / GTMC Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Comprehensive Community Health Centers Inc.
Glendale, California
Description: DENTAL ADMINISTRATOR JOB SUMMARY Oversees and directs the comprehensive operations of the dental practice, encompassing management of personnel, financial affairs, administrative processes, facility upkeep, productivity, and purchasing. Develops and implements programs, effectively allocates resources, and delegates responsibilities among dental staff. Maintains rigorous oversight of dental records to ensure adherence to regulatory standards and billing accuracy. Monitors activities and operations to ensure that the practice successfully meets its objectives. DENTAL ADMINISTRATOR ESSENTIAL DUTIES AND RESPONSIBILITIES Leadership and Direction: Provides strategic leadership, direction, and coordination for all general clinic operations across multiple dental sites, ensuring alignment with the CCHC's mission and vision. Work to strengthen the collaboration with all departments, including Medical, Outreach, BI, Billing, etc. Team Leadership: Guides and motivates employees to achieve all job objectives, fostering a collaborative environment that emphasizes excellence and accountability. Works closely with all the managers to maximize the efficiency of referral process between the departments. Operational Improvement: Proactively identifies and implements strategic changes to enhance clinic operations; collaborates with the Quality Improvement Department, Efficiency Team, Business Intelligence and others to conduct assessments, complete data insights, and improve practices. Coaching and Development: Conducts regular one-on-one meetings with clinic Managers and Leads to coach, mentor, and assist in establishing and implementing measurable goals and objectives tailored to each dental site's operational needs. Communication and Morale: Maintains high morale and positive relations among staff across all dental sites; schedules and leads periodic staff meetings to communicate policy updates, educate employees, and proactively address issues. Provider Collaboration: Organizes and facilitates Provider meetings with the Dental Director, ensuring effective communication and alignment on clinical objectives and best practices across all locations. Works closely with the Dental Director to recruit dental providers who are aligned with CCHC mission and vision. Data Analysis and Reporting: Gathers, analyzes, and reports data related to operational performance and quality metrics; routinely monitors key performance indicators across all dental clinics, addresses operational challenges, and provides actionable recommendations. Goal Management: Works closely with Dental Managers and Supervisors to ensure the achievement of dental, operational, and administrative goals; sets clear expectations for staff performance and fosters teamwork. Financial Oversight: Manages the overall operating budget for all dental sites, ensuring the achievement of financial performance targets. Analyzes quarterly budget variances greater than 5%, identifying root causes and implementing corrective actions. Provides oversight of daily collections and the accurate transfer to the accounting department. Patient Experience Enhancement: Develops, implements, and oversees initiatives aimed at improving patient experience across all sites. Performance Management: Conducts performance reviews for direct reports, making recommendations for merit increases, promotions, and disciplinary actions. Administrative Coordination: Ensures timely processing of all necessary paperwork for all sites, to maintain compliance, contracting, Compliance: Conducts regular audits of clinic operations, financial practices, and compliance to ensure adherence to policies and regulations; implements corrective actions as needed to address any discrepancies. Dental oversight and participation of all audits, including HRSA OSV and any health plan. Oversees the compliance and management of dental grants. Oversee health plan contracting. System Management: Oversees the utilization of Dental Electronic Health Record (EHR) systems across all dental sites, ensuring data accuracy and regulatory compliance. Collaborates with the IT department to assess system performance, identify opportunities for enhancements, and implement improvements to optimize clinical workflows. Scheduling and Staffing Support: Ensures targeted staffing levels are met across all clinics, working closely with Managers to address any gaps and optimize team performance. Collaborates with Dental Managers to modify provider schedules as needed, approves vacation and leave requests, and ensures adequate coverage to fill in during absences. DENTAL ADMINISTRATOR PATIENT EXPERIENCE EXPECTATIONS Oversee and manage the implementation and staff accountability of patient experience strategies Conduct regular audits and/or observations to ensure patient experience standards are practiced consistently across all clinic operations. Analyze patient feedback and performance metrics to identify improvement areas and develop actionable plans based on trends. Collaborate with Service Architects and Accountability Leaders to provide ongoing support, training, and guidance to staff. Model best practices and high standards in patient service to set a strong example for the team. Foster a culture that prioritizes patient needs, values feedback, and recognizes/rewards exceptional patient care. Requirements: DENTAL ADMINISTRATOR EDUCATION, TRAINING AND EXPERIENCE Bachelors degree, or higher required Minimum of five to seven years of work experience in dental operations, with increased responsibility. Minimum of five years of experience supervising staff. Minimum of three plus years of experience directly managing a dental Practice or clinic. DENTAL ADMINISTRATOR PAY RANGE: $77,000 - $82,000 ANNUALLY DENTAL ADMINISTRATOR (DENTAL) BENEFITS: Medical, Dental and Vision - 100% paid by Employer Life Insurance and Accidental Dismemberment - 100% paid by Employer Paid Holidays Paid Time Off 401K 401K Matching Flexible Spending Account Fringe Supplemental Insurance PHYSICAL DEMANDS Position requires prolonged sitting at a computer, some bending, lifting, stooping and stretching. Good eye-hand coordination and manual dexterity sufficient to operate a computer keyboard, photocopy machine, telephone, and other office equipment is also required. Employee must have normal range of hearing and eyesight. Ability to drive or arrange reliable transportation to clinic sites as needed for office functions such as professional meetings, seminars, conferences, and trainings. NOTE: The essential job functions for this position include, but may not be limited to those listed in this job description. Employees hired for this position must be able to perform the essential functions of this job without imposing significant risk of substantial harm to the health or safety of themselves or others We are committed to providing equal employment opportunities to all applicants, including those with arrest or conviction records. In accordance with the ULAC Fair Chance Ordinance, we will not inquire about or consider criminal history until after a candidate has received a copy of their background check report. All applicants will be evaluated based on their qualifications and ability to perform the essential functions of the job. For more information, please refer to LA County Fair Chance Hiring . PI49595a29cd3d-7234
09/03/2025
Full time
Description: DENTAL ADMINISTRATOR JOB SUMMARY Oversees and directs the comprehensive operations of the dental practice, encompassing management of personnel, financial affairs, administrative processes, facility upkeep, productivity, and purchasing. Develops and implements programs, effectively allocates resources, and delegates responsibilities among dental staff. Maintains rigorous oversight of dental records to ensure adherence to regulatory standards and billing accuracy. Monitors activities and operations to ensure that the practice successfully meets its objectives. DENTAL ADMINISTRATOR ESSENTIAL DUTIES AND RESPONSIBILITIES Leadership and Direction: Provides strategic leadership, direction, and coordination for all general clinic operations across multiple dental sites, ensuring alignment with the CCHC's mission and vision. Work to strengthen the collaboration with all departments, including Medical, Outreach, BI, Billing, etc. Team Leadership: Guides and motivates employees to achieve all job objectives, fostering a collaborative environment that emphasizes excellence and accountability. Works closely with all the managers to maximize the efficiency of referral process between the departments. Operational Improvement: Proactively identifies and implements strategic changes to enhance clinic operations; collaborates with the Quality Improvement Department, Efficiency Team, Business Intelligence and others to conduct assessments, complete data insights, and improve practices. Coaching and Development: Conducts regular one-on-one meetings with clinic Managers and Leads to coach, mentor, and assist in establishing and implementing measurable goals and objectives tailored to each dental site's operational needs. Communication and Morale: Maintains high morale and positive relations among staff across all dental sites; schedules and leads periodic staff meetings to communicate policy updates, educate employees, and proactively address issues. Provider Collaboration: Organizes and facilitates Provider meetings with the Dental Director, ensuring effective communication and alignment on clinical objectives and best practices across all locations. Works closely with the Dental Director to recruit dental providers who are aligned with CCHC mission and vision. Data Analysis and Reporting: Gathers, analyzes, and reports data related to operational performance and quality metrics; routinely monitors key performance indicators across all dental clinics, addresses operational challenges, and provides actionable recommendations. Goal Management: Works closely with Dental Managers and Supervisors to ensure the achievement of dental, operational, and administrative goals; sets clear expectations for staff performance and fosters teamwork. Financial Oversight: Manages the overall operating budget for all dental sites, ensuring the achievement of financial performance targets. Analyzes quarterly budget variances greater than 5%, identifying root causes and implementing corrective actions. Provides oversight of daily collections and the accurate transfer to the accounting department. Patient Experience Enhancement: Develops, implements, and oversees initiatives aimed at improving patient experience across all sites. Performance Management: Conducts performance reviews for direct reports, making recommendations for merit increases, promotions, and disciplinary actions. Administrative Coordination: Ensures timely processing of all necessary paperwork for all sites, to maintain compliance, contracting, Compliance: Conducts regular audits of clinic operations, financial practices, and compliance to ensure adherence to policies and regulations; implements corrective actions as needed to address any discrepancies. Dental oversight and participation of all audits, including HRSA OSV and any health plan. Oversees the compliance and management of dental grants. Oversee health plan contracting. System Management: Oversees the utilization of Dental Electronic Health Record (EHR) systems across all dental sites, ensuring data accuracy and regulatory compliance. Collaborates with the IT department to assess system performance, identify opportunities for enhancements, and implement improvements to optimize clinical workflows. Scheduling and Staffing Support: Ensures targeted staffing levels are met across all clinics, working closely with Managers to address any gaps and optimize team performance. Collaborates with Dental Managers to modify provider schedules as needed, approves vacation and leave requests, and ensures adequate coverage to fill in during absences. DENTAL ADMINISTRATOR PATIENT EXPERIENCE EXPECTATIONS Oversee and manage the implementation and staff accountability of patient experience strategies Conduct regular audits and/or observations to ensure patient experience standards are practiced consistently across all clinic operations. Analyze patient feedback and performance metrics to identify improvement areas and develop actionable plans based on trends. Collaborate with Service Architects and Accountability Leaders to provide ongoing support, training, and guidance to staff. Model best practices and high standards in patient service to set a strong example for the team. Foster a culture that prioritizes patient needs, values feedback, and recognizes/rewards exceptional patient care. Requirements: DENTAL ADMINISTRATOR EDUCATION, TRAINING AND EXPERIENCE Bachelors degree, or higher required Minimum of five to seven years of work experience in dental operations, with increased responsibility. Minimum of five years of experience supervising staff. Minimum of three plus years of experience directly managing a dental Practice or clinic. DENTAL ADMINISTRATOR PAY RANGE: $77,000 - $82,000 ANNUALLY DENTAL ADMINISTRATOR (DENTAL) BENEFITS: Medical, Dental and Vision - 100% paid by Employer Life Insurance and Accidental Dismemberment - 100% paid by Employer Paid Holidays Paid Time Off 401K 401K Matching Flexible Spending Account Fringe Supplemental Insurance PHYSICAL DEMANDS Position requires prolonged sitting at a computer, some bending, lifting, stooping and stretching. Good eye-hand coordination and manual dexterity sufficient to operate a computer keyboard, photocopy machine, telephone, and other office equipment is also required. Employee must have normal range of hearing and eyesight. Ability to drive or arrange reliable transportation to clinic sites as needed for office functions such as professional meetings, seminars, conferences, and trainings. NOTE: The essential job functions for this position include, but may not be limited to those listed in this job description. Employees hired for this position must be able to perform the essential functions of this job without imposing significant risk of substantial harm to the health or safety of themselves or others We are committed to providing equal employment opportunities to all applicants, including those with arrest or conviction records. In accordance with the ULAC Fair Chance Ordinance, we will not inquire about or consider criminal history until after a candidate has received a copy of their background check report. All applicants will be evaluated based on their qualifications and ability to perform the essential functions of the job. For more information, please refer to LA County Fair Chance Hiring . PI49595a29cd3d-7234
Catholic Housing for the Elderly & Handicapped Inc
Miami, Florida
Summary & Objective The Facility Executive Assistant is responsible to assist the Executive Director and the Administrator in coordinating the day to day operations in compliance with Local, State and Federal regulations. The Executive Assistant maintains organizational tasks which require internal and external working relationships by incorporating, the reinforcement of the corporation mission and values, as well as to coordinate the daily interaction within the different department heads within the facility, senior management and corporate office. Essential Functions Assists, Executive Director / Administrator in managing regulatory requirements with Agency for Healthcare Administration (AHCA), The Joint Commission (TJC), Center for Medicare and Medicaid Services (CMS) and other regulatory compliance agencies. Assumes responsibility in the performance of management duties and functions in the absence of the Administrator as delegated by the Administrator. Makes Administrative decisions in the absence of the Administrator necessary for the daily performance on the sixteen facilities and Catholic Housing Management. Responsible for monitoring/maintaining licensure renewal, contracting and credentialing applications. Responsible for the data collection/input and timely worksheet submission located on the shared drive. Represents has a voting member of the facility in the county healthcare preparedness coalition (if applicable) Prioritize grievances/concerns to the appropriate department head and informs, Executive Director / Administrator Coordinates and arranges seminars, conferences and travel plans for the Executive Director / Administrator Maintains and updates files for the Administration office Assists, Executive Director / Administrator in coordinating management team meetings as needed. Collects data and prepares daily, weekly, monthly quarterly reports and distributes as needed. Prepares, summaries and distribute meeting minutes for facility and corporate as required by organizational Bylaws (Professional Affairs, Quality Assurance Performance Improvement (QAPI), Quality Management Council (QMC) and Medical Staff Executive. Opens mail of the, Executive Director / Administrator pointing out items of highest priority. Participates in daily, weekly and/or monthly meetings as required or requested. Manages calendar of conference rooms for facility. Meets with Executive Director / Administrator to discuss escalated matters, obtain direction and set time frames for planned activities. Manages and maintains the facility Guardian Angel Program (if applicable) Independently facilitates family/residents issues and concerns, acts as the facility Liaison/Ambassador providing solutions using all resources, discretion and judgment. Maintains petty cash account including recording, disbursing and balancing of request and insuring that the cash is replenished in a timely manner. Review all resume's an Interview for all required facility positions. Processes all newly hired personnel, verifying references, obtaining payroll/personnel documentation, establishing personnel file. Processes newly hired employee enrolment on the Health Plan, Pension Plan, 403b Plan and Supplemental Life Insurance. Coordinates OSHA program with managers assuring compliance. Maintains permanent records for each corporation. (16) Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. Other Duties Exercises discretion and confidentiality with sensitive company information Interacts effectively with other departments, corporate office and Medical Staff. Promotes positive employee engagement, teamwork, mutual respect and safety work practices. Maintain your required certifications and mandatory skill updates. Comply with all policies, local, state and federal laws and regulations. Perform other duties as assigned. Supervisory Responsibility May serve as an interim department leader depending on need Physical Requirements Must be able to lift and/or move up to 50 pounds and push/pull up to 250+ pounds, walk, climb stair or ladders, stand on feet for extended periods of time, etc. if applicable Disclaimer The job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time. EEOC Statement CHM provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Knowledge & Experience Requirements Associate's degree (AA) or equivalent degree from two-year College or technical school 3 to 5 years' experience required Must use good judgment in executing job as employee deals with confidential information. Must have knowledge of computer office software Must be able to read, write and understand the English language PI50c771f20a2e-6383
09/03/2025
Full time
Summary & Objective The Facility Executive Assistant is responsible to assist the Executive Director and the Administrator in coordinating the day to day operations in compliance with Local, State and Federal regulations. The Executive Assistant maintains organizational tasks which require internal and external working relationships by incorporating, the reinforcement of the corporation mission and values, as well as to coordinate the daily interaction within the different department heads within the facility, senior management and corporate office. Essential Functions Assists, Executive Director / Administrator in managing regulatory requirements with Agency for Healthcare Administration (AHCA), The Joint Commission (TJC), Center for Medicare and Medicaid Services (CMS) and other regulatory compliance agencies. Assumes responsibility in the performance of management duties and functions in the absence of the Administrator as delegated by the Administrator. Makes Administrative decisions in the absence of the Administrator necessary for the daily performance on the sixteen facilities and Catholic Housing Management. Responsible for monitoring/maintaining licensure renewal, contracting and credentialing applications. Responsible for the data collection/input and timely worksheet submission located on the shared drive. Represents has a voting member of the facility in the county healthcare preparedness coalition (if applicable) Prioritize grievances/concerns to the appropriate department head and informs, Executive Director / Administrator Coordinates and arranges seminars, conferences and travel plans for the Executive Director / Administrator Maintains and updates files for the Administration office Assists, Executive Director / Administrator in coordinating management team meetings as needed. Collects data and prepares daily, weekly, monthly quarterly reports and distributes as needed. Prepares, summaries and distribute meeting minutes for facility and corporate as required by organizational Bylaws (Professional Affairs, Quality Assurance Performance Improvement (QAPI), Quality Management Council (QMC) and Medical Staff Executive. Opens mail of the, Executive Director / Administrator pointing out items of highest priority. Participates in daily, weekly and/or monthly meetings as required or requested. Manages calendar of conference rooms for facility. Meets with Executive Director / Administrator to discuss escalated matters, obtain direction and set time frames for planned activities. Manages and maintains the facility Guardian Angel Program (if applicable) Independently facilitates family/residents issues and concerns, acts as the facility Liaison/Ambassador providing solutions using all resources, discretion and judgment. Maintains petty cash account including recording, disbursing and balancing of request and insuring that the cash is replenished in a timely manner. Review all resume's an Interview for all required facility positions. Processes all newly hired personnel, verifying references, obtaining payroll/personnel documentation, establishing personnel file. Processes newly hired employee enrolment on the Health Plan, Pension Plan, 403b Plan and Supplemental Life Insurance. Coordinates OSHA program with managers assuring compliance. Maintains permanent records for each corporation. (16) Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. Other Duties Exercises discretion and confidentiality with sensitive company information Interacts effectively with other departments, corporate office and Medical Staff. Promotes positive employee engagement, teamwork, mutual respect and safety work practices. Maintain your required certifications and mandatory skill updates. Comply with all policies, local, state and federal laws and regulations. Perform other duties as assigned. Supervisory Responsibility May serve as an interim department leader depending on need Physical Requirements Must be able to lift and/or move up to 50 pounds and push/pull up to 250+ pounds, walk, climb stair or ladders, stand on feet for extended periods of time, etc. if applicable Disclaimer The job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time. EEOC Statement CHM provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Knowledge & Experience Requirements Associate's degree (AA) or equivalent degree from two-year College or technical school 3 to 5 years' experience required Must use good judgment in executing job as employee deals with confidential information. Must have knowledge of computer office software Must be able to read, write and understand the English language PI50c771f20a2e-6383
Job Title: Development Scientific Director (DSD) Location: Cambridge, MA, About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Development Scientific Director (DSD) role in the Neurology Clinical Development department provides clinical scientific leadership for Alzheimer's disease clinical trials. The DSD contributes to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional collaboration to ensure scientific integrity and operational excellence. This role requires a scientifically and operationally focused, organized, and emotionally intelligent professional with strong analytical, communication, and leadership skills. At Sanofi we chase the miracles of science. Sanofi believes that the more we understand about disease pathogenesis in the human nervous system, the greater the chance we can produce life-changing therapies. Sanofi has a large internal research team including the Genomic Medicine Unit (GMU), which are committed to building the future pipeline in various neurological and ophthalmological diseases. Over the next five years, the Neurology & Ophthalmology Development (NOD) group plans to regularly test in the clinic potentially disease-modifying treatments for Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), as well as other CNS diseases, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Clinical Study Leadership Provide scientific expertise for study protocols, data interpretation, and clinical study reports. Ensure scientific relevance and quality of clinical data throughout study execution. Support feasibility assessments, risk management, and validation of clinical data. Participate in internal governance and regulatory meetings. Cross-Functional Collaboration Serve as the scientific reference for study teams, investigators, and internal stakeholders. Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs, Biostatistics, Clinical Study Units, Medical Affairs, and CROs to optimize study design and execution. Study Document Development Author, review, and validate study-related documents including trial protocols, informed consent forms, case report forms, risk management plans, training materials, clinical study reports, and publications. Develop materials for and organize investigator meetings, steering committees, and independent data monitoring committees. Contribute to regulatory submissions and respond to health authority queries. Scientific Expertise & Strategy Maintain deep knowledge of Alzheimer's disease pathophysiology, biomarkers, disease staging, clinical management, and drug development. Contribute to biomarker strategy and mechanism-of-action understanding. Support clinical development plans and integrated development strategies. Provide scientific input for in-licensing evaluations and strategic initiatives as needed. Operational Oversight Define study timelines, budgets, and risk mitigation plans in collaboration with clinical operations and project management. Ensure harmonization of study documents and alignment across projects. Escalate and resolve study-level issues, sharing lessons learned across teams QUALIFICATIONS Advanced degree (PhD, PharmD, or equivalent in Life/Health Sciences); MPH or Master's with extensive drug development experience may be considered. Minimum 5 years of clinical development experience in academic, biopharma, or CRO. Strong scientific and clinical development expertise, especially in neurology. Clinical research and drug development expertise in Alzheimer's disease is highly desired. Excellent communication, teaching, and cross-functional collaboration skills. Fluent in English (spoken and written). Experience working in a matrixed environment with global teams. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
09/02/2025
Full time
Job Title: Development Scientific Director (DSD) Location: Cambridge, MA, About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Development Scientific Director (DSD) role in the Neurology Clinical Development department provides clinical scientific leadership for Alzheimer's disease clinical trials. The DSD contributes to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional collaboration to ensure scientific integrity and operational excellence. This role requires a scientifically and operationally focused, organized, and emotionally intelligent professional with strong analytical, communication, and leadership skills. At Sanofi we chase the miracles of science. Sanofi believes that the more we understand about disease pathogenesis in the human nervous system, the greater the chance we can produce life-changing therapies. Sanofi has a large internal research team including the Genomic Medicine Unit (GMU), which are committed to building the future pipeline in various neurological and ophthalmological diseases. Over the next five years, the Neurology & Ophthalmology Development (NOD) group plans to regularly test in the clinic potentially disease-modifying treatments for Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), as well as other CNS diseases, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Clinical Study Leadership Provide scientific expertise for study protocols, data interpretation, and clinical study reports. Ensure scientific relevance and quality of clinical data throughout study execution. Support feasibility assessments, risk management, and validation of clinical data. Participate in internal governance and regulatory meetings. Cross-Functional Collaboration Serve as the scientific reference for study teams, investigators, and internal stakeholders. Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs, Biostatistics, Clinical Study Units, Medical Affairs, and CROs to optimize study design and execution. Study Document Development Author, review, and validate study-related documents including trial protocols, informed consent forms, case report forms, risk management plans, training materials, clinical study reports, and publications. Develop materials for and organize investigator meetings, steering committees, and independent data monitoring committees. Contribute to regulatory submissions and respond to health authority queries. Scientific Expertise & Strategy Maintain deep knowledge of Alzheimer's disease pathophysiology, biomarkers, disease staging, clinical management, and drug development. Contribute to biomarker strategy and mechanism-of-action understanding. Support clinical development plans and integrated development strategies. Provide scientific input for in-licensing evaluations and strategic initiatives as needed. Operational Oversight Define study timelines, budgets, and risk mitigation plans in collaboration with clinical operations and project management. Ensure harmonization of study documents and alignment across projects. Escalate and resolve study-level issues, sharing lessons learned across teams QUALIFICATIONS Advanced degree (PhD, PharmD, or equivalent in Life/Health Sciences); MPH or Master's with extensive drug development experience may be considered. Minimum 5 years of clinical development experience in academic, biopharma, or CRO. Strong scientific and clinical development expertise, especially in neurology. Clinical research and drug development expertise in Alzheimer's disease is highly desired. Excellent communication, teaching, and cross-functional collaboration skills. Fluent in English (spoken and written). Experience working in a matrixed environment with global teams. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Requisition ID: 6639 Job Title: Sr Product Manager Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit . This role champions the success of our RFA product portfolio, driving category growth through bold strategic vision and flawless execution of business and marketing plans. Develops and delivers a financial budget that fuels growth year after year-while shaping strategies that win in the marketplace. From conducting market assessments and defining competitive pricing, to forging impactful GPO/IDN partnerships and staying ahead of the competitive landscape, this is central to the business and will be high-impact decision-maker. This position manages key customer relationships, orchestrates successful product launches, and optimizes gross profit and operating profit performance. In addition this role will focus on the future of our pipeline by advising Global Strategic Marketing on market opportunities and product innovation. Reporting directly to the Associate Director of Marketing, RFA Solutions. Key Responsibilities: Assist in the development and execution of effective plans and programs, both strategic and tactical, to drive net sales, operating profit, and market share for categories. Maintain full P&L management responsibility for product portfolios. Develop long-term strategic business plans and marketing plans for product portfolio segments. Develop pricing strategies that support the growth and profitability of the business. Collaborate with Sales, Planning and Finance teams to develop timely and accurate forecasts to ensure required fill rates on existing and new products, supporting sector goals to improve return on working capital and working closely with sales team to develop a financial and demand forecast with a high degree of accuracy. Support in the development of GPO/ IDN strategies to grow and maintain the business. Constantly evaluate product mix to reduce redundancy and drive strategic objectives for the category. Responsible for launching new products including the development of branding, pricing, positioning, messaging, marketing campaigns, training, and forecasts. Support and guide development and execution of tools and training to improve and maintain sales force competency, drive new product sales and provide superior customer service. Lead the development & execution of digital marketing & demand generation programs. Assist in developing key initiatives and programs by gathering customer insights through end-user focus with physicians / clinicians. Establish and manage relationships with industry KOLs. Responsible for providing effective communication with sales team, as well as cross-functional teams, to help ensure collaboration and understanding of the business. Actively seek and positively respond to performance and personal development feedback, while initiating activities to enhance personal functional effectiveness to realize full career potential. This is an on-site position located in Alpharetta/Metro Atlanta area. PRIMARY PARTNERS AND CUSTOMERS: Primary Partners: IVP Pain Franchise Sales Leadership and Sales Team, Marketing (Global Strategic Marketing and North America Regional Team), Research & Development, Marketing Communications, Clinical and Medical Affairs, Regulatory, Quality, Finance, Product Supply, Sales Advisory Board Members. External Customers: Avanos Customers (healthcare/ alternate site facilities), Distributors, Key Clinical Opinion Leaders, GPO's. Your qualifications Required: Bachelor's degree required At least 5 years of product management experience in the health care industry (or other regulated industry), gained through marketing roles or a combination of sales and marketing roles. Ability to travel at least 25% Ability to manage cross-functional teams without direct reporting relationships Ability to collaborate successfully and influence decisions Exceptional written, verbal and communication skills Experience in forecasting and demand planning Development of strategic business plans Development of key tactics and execution plans that drive strategic goals Ability to assess the market and competitive landscape Successful product launch experience Gaining and understanding the internal/external customer perspective Management of an advertising and promotion budget Knowledge and experience with branding and brand management Ability to multi-task and work under pressure in a fast-paced environment Strong computer skills including: Microsoft Word , Excel , Outlook, PowerPoint Preferred: MBA with either a Marketing or Business-related concentration Product management experience within medical devices In-depth understanding of the medical device legal and regulatory pathways Complex project management experience Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. Avanos also offers the following: benefits on day 1 free onsite gym onsite cafeteria HQ region voted 'best place to live' by USA Today uncapped sales commissions
09/02/2025
Full time
Requisition ID: 6639 Job Title: Sr Product Manager Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit . This role champions the success of our RFA product portfolio, driving category growth through bold strategic vision and flawless execution of business and marketing plans. Develops and delivers a financial budget that fuels growth year after year-while shaping strategies that win in the marketplace. From conducting market assessments and defining competitive pricing, to forging impactful GPO/IDN partnerships and staying ahead of the competitive landscape, this is central to the business and will be high-impact decision-maker. This position manages key customer relationships, orchestrates successful product launches, and optimizes gross profit and operating profit performance. In addition this role will focus on the future of our pipeline by advising Global Strategic Marketing on market opportunities and product innovation. Reporting directly to the Associate Director of Marketing, RFA Solutions. Key Responsibilities: Assist in the development and execution of effective plans and programs, both strategic and tactical, to drive net sales, operating profit, and market share for categories. Maintain full P&L management responsibility for product portfolios. Develop long-term strategic business plans and marketing plans for product portfolio segments. Develop pricing strategies that support the growth and profitability of the business. Collaborate with Sales, Planning and Finance teams to develop timely and accurate forecasts to ensure required fill rates on existing and new products, supporting sector goals to improve return on working capital and working closely with sales team to develop a financial and demand forecast with a high degree of accuracy. Support in the development of GPO/ IDN strategies to grow and maintain the business. Constantly evaluate product mix to reduce redundancy and drive strategic objectives for the category. Responsible for launching new products including the development of branding, pricing, positioning, messaging, marketing campaigns, training, and forecasts. Support and guide development and execution of tools and training to improve and maintain sales force competency, drive new product sales and provide superior customer service. Lead the development & execution of digital marketing & demand generation programs. Assist in developing key initiatives and programs by gathering customer insights through end-user focus with physicians / clinicians. Establish and manage relationships with industry KOLs. Responsible for providing effective communication with sales team, as well as cross-functional teams, to help ensure collaboration and understanding of the business. Actively seek and positively respond to performance and personal development feedback, while initiating activities to enhance personal functional effectiveness to realize full career potential. This is an on-site position located in Alpharetta/Metro Atlanta area. PRIMARY PARTNERS AND CUSTOMERS: Primary Partners: IVP Pain Franchise Sales Leadership and Sales Team, Marketing (Global Strategic Marketing and North America Regional Team), Research & Development, Marketing Communications, Clinical and Medical Affairs, Regulatory, Quality, Finance, Product Supply, Sales Advisory Board Members. External Customers: Avanos Customers (healthcare/ alternate site facilities), Distributors, Key Clinical Opinion Leaders, GPO's. Your qualifications Required: Bachelor's degree required At least 5 years of product management experience in the health care industry (or other regulated industry), gained through marketing roles or a combination of sales and marketing roles. Ability to travel at least 25% Ability to manage cross-functional teams without direct reporting relationships Ability to collaborate successfully and influence decisions Exceptional written, verbal and communication skills Experience in forecasting and demand planning Development of strategic business plans Development of key tactics and execution plans that drive strategic goals Ability to assess the market and competitive landscape Successful product launch experience Gaining and understanding the internal/external customer perspective Management of an advertising and promotion budget Knowledge and experience with branding and brand management Ability to multi-task and work under pressure in a fast-paced environment Strong computer skills including: Microsoft Word , Excel , Outlook, PowerPoint Preferred: MBA with either a Marketing or Business-related concentration Product management experience within medical devices In-depth understanding of the medical device legal and regulatory pathways Complex project management experience Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. Avanos also offers the following: benefits on day 1 free onsite gym onsite cafeteria HQ region voted 'best place to live' by USA Today uncapped sales commissions
Job Title: Sr. Director, Global Market Access and Pricing Lead - Oncology Location: Cambridge, MA About the Job Sanofi Genzyme's Oncology franchise has a diverse and fast-growing portfolio. This includes the late-stage launching assets (Sarclisa / isatuximab / anti-CD38) in multiple myeloma, as well as earlier compounds in oncology. We are rapidly advancing a robust and reinvigorated oncology pipeline in different malignancies including colorectal and other GI cancers, lung cancers, and hematology. Oncology is at the forefront of the key issues hence leadership in access policy is critical for Sanofi success and support timely access. We are navigating in an uncertain and evolving environment, where different structural access hurdles have been identified/prioritized. Market Access is central to guiding cross-functional efforts to mitigate access-related risks, and prepare for pipeline future launches . The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing strategy, plans and tactics for the hematology and solid tumor pipeline through best-in-class methodologies. Main areas of focus will be as follows: Lead all relevant strategic and tactical activities to support the Market Access inputs to the pipeline assets strategy (landscaping, payer requirements, value positioning, pricing/access assumptions ) Lead cross-brand projects as part of the Access policy workforce, in collaboration with other functions (e.g., combinations challenges, alternative endpoints, etc.) This is a highly collaborative role which will coordinate the relevant cross-functional projects and that must work cohesively with all relevant stakeholders within Market Access (HEVA, GMAX CoE, Affiliates ) and beyond (Commercial, Clinical, Medical, Biostats etc ) to build successful access and pricing strategies, plan and tools in order to realize the full pricing and access potential of Sanofi solutions. The role will report to the Global Head of Market Access & Pricing - Oncology . The position will provide exposure to pre-POC, post-PoC and pre-launch activities. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: As per task / indication / asset, the incumbent will lead the efforts according to needs, priorities and ramp-up. Increasing autonomy expected to grow over time. Collaborates to the development and supports execution of the access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (e.g. Commercial, Clinical, medical, regulatory etc.) Partner effectively with relevant departments (e.g. Commercial, Clinical Development, Regulatory Affairs, Medical Affairs, HEOR ) to influence the market assessment, product positioning, and TPP by providing strategic input regarding market access, reimbursement and pricing information throughout the product life cycle. For each indications / asset under scope, responsible for the timely execution of assigned activities pertaining to the following areas (lead or support as per cases), such as: Foundational knowledge of disease and payer unmet need Competitive assessment Early market access success factors / risks identification Fact based early potential assessments (price/access assumptions for forecasting) and scenario development Informed market access input to development plan & pivotal trial design Coordinates the relevant Market Access cross-functional working groups / sub-team / projects ensuring relevant input / engagement from key markets Develops and maintains a high level of knowledge with regards to the scientific, clinical, strategic pricing and commercial developments relevant to the assets/indications under scope Develops and maintains a robust understanding of relevant pricing and reimbursement criteria used by payers in key markets to make informed decisions about payer strategy, plans and tactics About You SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Minimum 10 years of demonstrated professional experience with a proven track record in Global Market Access. Experience in US market dynamics, Health Economics and Outcomes Research (HEOR), and healthcare policy is highly valued. Demonstrated global access launch leadership experience Demonstrated business acumen, analytical and financial skills to evaluate investment strategies, comfortable with product forecast and P&L Demonstrated ability to leverage research, scenario analyses and payor and pricing insights to generate global integrated market access payer and pricing strategies and plans to maximize product differentiation most relevant to payers Demonstrated ability to effectively engage with a diverse group of leaders across within a matrix organization; demonstrated ability to influence and lead without direct reporting relationships. Strong organizational and project management skills, demonstrated ability to successfully drive a project to completion with positive results Demonstrated understanding of how the customer perceives their own business / institutional mandate relative to competition, understands customer's needs, culture, and how things get done in the customer environment Sound grounding in HEOR (modeling, comparative data, data generation, RWE ) to allow efficient and synergistic partnership Oncology background highly preferred Significant experience / exposure to clinical development Team management experience KEY WORKING RELATIONSHIPS Regular, close contact with: GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) HEVA leads Major Local Market Access leads, franchise and medical heads Market Access CoEs / GTMC Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
09/02/2025
Full time
Job Title: Sr. Director, Global Market Access and Pricing Lead - Oncology Location: Cambridge, MA About the Job Sanofi Genzyme's Oncology franchise has a diverse and fast-growing portfolio. This includes the late-stage launching assets (Sarclisa / isatuximab / anti-CD38) in multiple myeloma, as well as earlier compounds in oncology. We are rapidly advancing a robust and reinvigorated oncology pipeline in different malignancies including colorectal and other GI cancers, lung cancers, and hematology. Oncology is at the forefront of the key issues hence leadership in access policy is critical for Sanofi success and support timely access. We are navigating in an uncertain and evolving environment, where different structural access hurdles have been identified/prioritized. Market Access is central to guiding cross-functional efforts to mitigate access-related risks, and prepare for pipeline future launches . The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing strategy, plans and tactics for the hematology and solid tumor pipeline through best-in-class methodologies. Main areas of focus will be as follows: Lead all relevant strategic and tactical activities to support the Market Access inputs to the pipeline assets strategy (landscaping, payer requirements, value positioning, pricing/access assumptions ) Lead cross-brand projects as part of the Access policy workforce, in collaboration with other functions (e.g., combinations challenges, alternative endpoints, etc.) This is a highly collaborative role which will coordinate the relevant cross-functional projects and that must work cohesively with all relevant stakeholders within Market Access (HEVA, GMAX CoE, Affiliates ) and beyond (Commercial, Clinical, Medical, Biostats etc ) to build successful access and pricing strategies, plan and tools in order to realize the full pricing and access potential of Sanofi solutions. The role will report to the Global Head of Market Access & Pricing - Oncology . The position will provide exposure to pre-POC, post-PoC and pre-launch activities. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: As per task / indication / asset, the incumbent will lead the efforts according to needs, priorities and ramp-up. Increasing autonomy expected to grow over time. Collaborates to the development and supports execution of the access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (e.g. Commercial, Clinical, medical, regulatory etc.) Partner effectively with relevant departments (e.g. Commercial, Clinical Development, Regulatory Affairs, Medical Affairs, HEOR ) to influence the market assessment, product positioning, and TPP by providing strategic input regarding market access, reimbursement and pricing information throughout the product life cycle. For each indications / asset under scope, responsible for the timely execution of assigned activities pertaining to the following areas (lead or support as per cases), such as: Foundational knowledge of disease and payer unmet need Competitive assessment Early market access success factors / risks identification Fact based early potential assessments (price/access assumptions for forecasting) and scenario development Informed market access input to development plan & pivotal trial design Coordinates the relevant Market Access cross-functional working groups / sub-team / projects ensuring relevant input / engagement from key markets Develops and maintains a high level of knowledge with regards to the scientific, clinical, strategic pricing and commercial developments relevant to the assets/indications under scope Develops and maintains a robust understanding of relevant pricing and reimbursement criteria used by payers in key markets to make informed decisions about payer strategy, plans and tactics About You SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Minimum 10 years of demonstrated professional experience with a proven track record in Global Market Access. Experience in US market dynamics, Health Economics and Outcomes Research (HEOR), and healthcare policy is highly valued. Demonstrated global access launch leadership experience Demonstrated business acumen, analytical and financial skills to evaluate investment strategies, comfortable with product forecast and P&L Demonstrated ability to leverage research, scenario analyses and payor and pricing insights to generate global integrated market access payer and pricing strategies and plans to maximize product differentiation most relevant to payers Demonstrated ability to effectively engage with a diverse group of leaders across within a matrix organization; demonstrated ability to influence and lead without direct reporting relationships. Strong organizational and project management skills, demonstrated ability to successfully drive a project to completion with positive results Demonstrated understanding of how the customer perceives their own business / institutional mandate relative to competition, understands customer's needs, culture, and how things get done in the customer environment Sound grounding in HEOR (modeling, comparative data, data generation, RWE ) to allow efficient and synergistic partnership Oncology background highly preferred Significant experience / exposure to clinical development Team management experience KEY WORKING RELATIONSHIPS Regular, close contact with: GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) HEVA leads Major Local Market Access leads, franchise and medical heads Market Access CoEs / GTMC Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Director of Public Policy Division US-MI-Lansing Job ID: Type: Regular Full-Time # of Openings: 1 Category: Management Farm Bureau Center Overview Director of Public Policy Division Objective Directs engagement objectives to develop and maintain productive relations with all levels of government to support and enhance Michigan Farm Bureau's member policy development process. Develops plans, policies, and teams to build relationships and liaise with government entities (federal, state, or local) that regulate or influence production agriculture. Directs ongoing monitoring and analysis of proposed legislation, emerging issues, and trends to determine the potential impact on the industry and organization. Collaborates with industry groups and organizations with complementary objectives. Responsibilities Director of Public Policy Division Responsibilities Plan, coordinate, and manage the activities of the division to maximize staff talents, organization resources, and policy implementation success. Work to maintain recognition of the organization as one of the top lobbying organizations in Michigan's capitol. Direct and coordinate the development and dissemination of information materials on probable issues affecting agriculture for use by appropriate county and state committees, officers, boards, affiliated company personnel, and Michigan Farm Bureau staff in formulating official policy positions to guide the organization in effectively solving such issues. Direct activities of the state government relations staff within the division to successfully carry out policy through legislative and regulatory action, and to keep members informed and trained to take effective grassroots action. Qualifications Director of Public Policy Division Qualifications Required Bachelor's degree in agriculture, agribusiness, political science, or public policy required. Master's degree preferred. Five to seven years' experience in the field of public policy or legislative services. Five to seven five years' experience in an agricultural organization or business with management responsibilities required. Minimum five years supervisory/management experience required. Experience in policy analysis, research, advocacy, government affairs, lobbying, or consulting required. Understanding of the policy landscape, legislative processes, and the specific issues relevant to the organization or sector. Note: Farm Bureau offers a full benefit package including medical, dental, vision, and 401K. PM19 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Compensation details: 09 Yearly Salary PI26030d043aab-4913
09/01/2025
Full time
Director of Public Policy Division US-MI-Lansing Job ID: Type: Regular Full-Time # of Openings: 1 Category: Management Farm Bureau Center Overview Director of Public Policy Division Objective Directs engagement objectives to develop and maintain productive relations with all levels of government to support and enhance Michigan Farm Bureau's member policy development process. Develops plans, policies, and teams to build relationships and liaise with government entities (federal, state, or local) that regulate or influence production agriculture. Directs ongoing monitoring and analysis of proposed legislation, emerging issues, and trends to determine the potential impact on the industry and organization. Collaborates with industry groups and organizations with complementary objectives. Responsibilities Director of Public Policy Division Responsibilities Plan, coordinate, and manage the activities of the division to maximize staff talents, organization resources, and policy implementation success. Work to maintain recognition of the organization as one of the top lobbying organizations in Michigan's capitol. Direct and coordinate the development and dissemination of information materials on probable issues affecting agriculture for use by appropriate county and state committees, officers, boards, affiliated company personnel, and Michigan Farm Bureau staff in formulating official policy positions to guide the organization in effectively solving such issues. Direct activities of the state government relations staff within the division to successfully carry out policy through legislative and regulatory action, and to keep members informed and trained to take effective grassroots action. Qualifications Director of Public Policy Division Qualifications Required Bachelor's degree in agriculture, agribusiness, political science, or public policy required. Master's degree preferred. Five to seven years' experience in the field of public policy or legislative services. Five to seven five years' experience in an agricultural organization or business with management responsibilities required. Minimum five years supervisory/management experience required. Experience in policy analysis, research, advocacy, government affairs, lobbying, or consulting required. Understanding of the policy landscape, legislative processes, and the specific issues relevant to the organization or sector. Note: Farm Bureau offers a full benefit package including medical, dental, vision, and 401K. PM19 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Compensation details: 09 Yearly Salary PI26030d043aab-4913
This position will report directly to the Head of Program Management for Regulatory Affairs. Development and maintenance of key project artifacts, ensuring that project management lifecycle has been applied to projects and documents are drafted, reviewed and approved in accordance with the RAD Program guidelines. Client Details Leading Financial Services located in New York, New York, looking for a Regulatory Project Manager. Description Management of one or more regulatory projects that span across various businesses in the Americas, and which can be part of larger globally run programs. Oversight of implementation and disciplined execution against regulatory timeline and agreed deliverables. Secure the staffing of the project team, with the support of Project Director and/or relevant governance body in charge of allocating resources. Frame the project upfront, define the most adequate governance to lead the project to success and get sign off. Gather project requirements, develop and maintain project documentation; Build/consolidate and maintain the project plan, effectively manage unplanned events, manage dependencies and critical path; Create and adhere to detailed project schedules Weekly reporting of project timelines, budgets, and issues Ensure robust documentation of project achievements, issues, risks, dependencies and escalation to management where needed. Define for the project the key milestones, impacts, risks and mitigation plan to avoid project delays and escalation process. Regular interaction with senior management stakeholders in Working Groups and Steering Committees Close collaboration with various departments, project stakeholders, and global programs to gain a full understanding of the regulations and their impact on the business Drive the project team to completion in close interaction with the Project Sponsor, ensure effective communication, continuous alignment of all contributors and timely running of governance routines; Take responsibility for - when appropriate - some of the actions and analysis related to the project, without losing focus on the roadmap. Perform project retrospective to leverage on experience and learn lessons for improvement for the future. Manage external partner(s) and ensure productive and efficient interactions, if required on a project. Undertake detailed review and management of budgets related to projects, including out of scope activities using the defined change management process. Perform other tasks or assignments, as delegated by Regulatory Affairs management. Profile Minimum bachelor's degree from reputed University with good academic record Experience using project management software Ability to adapt and work in a changing environment Logical and structured approach to planning and problem solving and decision-making Proven ability to collaborate with partners across multiple disciplines and functions, with very good interpersonal skills Readiness to work in a global, fast-paced environment and under tight timelines to deliver high-quality results Good Microsoft Office skills - Excel, Word, Visio and PowerPoint Ability to anticipate issues and aggressively drive initiatives to achieve results Job Offer Competitive compensation daily rate based on candidate's previous experience. Apply today using the link and your resume will be considered in the next 24 hours! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
07/21/2022
Full time
This position will report directly to the Head of Program Management for Regulatory Affairs. Development and maintenance of key project artifacts, ensuring that project management lifecycle has been applied to projects and documents are drafted, reviewed and approved in accordance with the RAD Program guidelines. Client Details Leading Financial Services located in New York, New York, looking for a Regulatory Project Manager. Description Management of one or more regulatory projects that span across various businesses in the Americas, and which can be part of larger globally run programs. Oversight of implementation and disciplined execution against regulatory timeline and agreed deliverables. Secure the staffing of the project team, with the support of Project Director and/or relevant governance body in charge of allocating resources. Frame the project upfront, define the most adequate governance to lead the project to success and get sign off. Gather project requirements, develop and maintain project documentation; Build/consolidate and maintain the project plan, effectively manage unplanned events, manage dependencies and critical path; Create and adhere to detailed project schedules Weekly reporting of project timelines, budgets, and issues Ensure robust documentation of project achievements, issues, risks, dependencies and escalation to management where needed. Define for the project the key milestones, impacts, risks and mitigation plan to avoid project delays and escalation process. Regular interaction with senior management stakeholders in Working Groups and Steering Committees Close collaboration with various departments, project stakeholders, and global programs to gain a full understanding of the regulations and their impact on the business Drive the project team to completion in close interaction with the Project Sponsor, ensure effective communication, continuous alignment of all contributors and timely running of governance routines; Take responsibility for - when appropriate - some of the actions and analysis related to the project, without losing focus on the roadmap. Perform project retrospective to leverage on experience and learn lessons for improvement for the future. Manage external partner(s) and ensure productive and efficient interactions, if required on a project. Undertake detailed review and management of budgets related to projects, including out of scope activities using the defined change management process. Perform other tasks or assignments, as delegated by Regulatory Affairs management. Profile Minimum bachelor's degree from reputed University with good academic record Experience using project management software Ability to adapt and work in a changing environment Logical and structured approach to planning and problem solving and decision-making Proven ability to collaborate with partners across multiple disciplines and functions, with very good interpersonal skills Readiness to work in a global, fast-paced environment and under tight timelines to deliver high-quality results Good Microsoft Office skills - Excel, Word, Visio and PowerPoint Ability to anticipate issues and aggressively drive initiatives to achieve results Job Offer Competitive compensation daily rate based on candidate's previous experience. Apply today using the link and your resume will be considered in the next 24 hours! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Guilford Technical Community College
Jamestown, North Carolina
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
02/27/2022
Full time
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
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.
NC State Agency needs attorney to serve as Associate Legal Counsel I to prosecute cases before the Commission involving character qualifications of applicants. License to practice law in the State of NC and responsible professional experience required. $72,324 - $86,788 (based on experience and qualifications), plus excellent benefits. Must reside in Raleigh area. Distinguishing Features of the Class An employee in this class performs legal services for areas of law that are limited in scope and complexity in comparison with the Senior Attorney level, may assist higher level attorneys with cases, serves as legal counsel for the Commission on simple disciplinary and character application cases, conducts settlement negotiations and oversees case management. Work involves providing advice to non-attorney complaint and information staff on cases, writing informational materials on legal matters, and overseeing the work of the Administrative Procedures Act coordinator to assure a thorough and timely rulemaking process. Employee prepares legal documents and presents cases to the Commission. Employee conducts legal research in the law relating to licensing and professional discipline, and keeps informed of Commission policies and actions. Independent professional judgment, initiative and public contact skills are essential in performing various duties. Work requires considerable knowledge of State real estate laws and Commission policies and rules, as well as strong analytical skills. Work is performed under the general supervision of the Director, Assistant Director of Regulatory Affairs, and Deputy Legal Counsel and is reviewed through discussion, results achieved, and feedback from the Commission, licensees and the public. Application deadline September 13. NC Real Estate Commission. EOE. recblid gmlqowprb6wx0jwyfq8fcb5iw9g3dp
09/13/2021
Full time
NC State Agency needs attorney to serve as Associate Legal Counsel I to prosecute cases before the Commission involving character qualifications of applicants. License to practice law in the State of NC and responsible professional experience required. $72,324 - $86,788 (based on experience and qualifications), plus excellent benefits. Must reside in Raleigh area. Distinguishing Features of the Class An employee in this class performs legal services for areas of law that are limited in scope and complexity in comparison with the Senior Attorney level, may assist higher level attorneys with cases, serves as legal counsel for the Commission on simple disciplinary and character application cases, conducts settlement negotiations and oversees case management. Work involves providing advice to non-attorney complaint and information staff on cases, writing informational materials on legal matters, and overseeing the work of the Administrative Procedures Act coordinator to assure a thorough and timely rulemaking process. Employee prepares legal documents and presents cases to the Commission. Employee conducts legal research in the law relating to licensing and professional discipline, and keeps informed of Commission policies and actions. Independent professional judgment, initiative and public contact skills are essential in performing various duties. Work requires considerable knowledge of State real estate laws and Commission policies and rules, as well as strong analytical skills. Work is performed under the general supervision of the Director, Assistant Director of Regulatory Affairs, and Deputy Legal Counsel and is reviewed through discussion, results achieved, and feedback from the Commission, licensees and the public. Application deadline September 13. NC Real Estate Commission. EOE. recblid gmlqowprb6wx0jwyfq8fcb5iw9g3dp
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
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our location in Alameda, California, currently has an opportunity for a Senior Manager, Public Affairs - Diabetes Care. The Public Affairs function for Abbott's diabetes care business has global responsibility for public relations activities for the world-leading sensing technology platform including FreeStyle Libre for people with diabetes and Abbott's Libre Sense Glucose Sport Biosensor designed for athletic performance. The successful candidate is passionate about consumer technology and its impact on human health. Seeking a candidate who is a strong storyteller in consumer, tech, and health, and has a proven-track record of top-tier media relations skills, can create compelling internal and external content, manage and anticipate crisis and issues, and develop international PR programming. The candidate will be self-motivated and nimble, thrive in a fast-paced dynamic environment, and have experience in supporting and executing successful PR and communications programs. Seeking a candidate with an ability to manage multiple projects across time zones, experience in working with other PR teams, agencies and has experience in managing crisis scenarios (pro-active and reactive), and supporting employee communications. The position will report directly to the the Head of Public Affairs for Abbott's diabetes care business. All division PA functions have a line reporting relationship to Corporate Public Affairs. WHAT YOU'LL DO Provide strategic counsel to marketing groups, internal/external clients, and country-level leadership on business-related efforts and initiatives; partner with various stakeholders including regulatory affairs, operations, quality, R&D, HR, government affairs, investor relations, legal, finance and senior management. Support the development and execution of external public relations strategies and approaches for key global product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. Work extensively with U.S. and international business, including affiliates and public affairs colleagues outside of the U.S. as well as agency partners. Assist director in developing plans, content, and supporting communication needs of country managers and affiliates around the world. Oversee PR agency management and/or PR agency selection process as needed. Work extensively with top-tier business, technology, lifestyle and consumer reporters (both proactively and reactively) to enhance and protect the company's reputation as well as advance business objectives. Develop compelling consumer-focused storylines, positioning and key messaging for the business. Assist with executive communications strategy and development of internal communication materials. Identify and anticipate issues and working with appropriate functions to counsel management on reputation/business impact and influence business decision making process. Develop multimedia, content and social and digital strategies to complement key Public Affairs campaigns. Bring to the table an understanding of today's communications environment amongst earned, owned, social and paid media and how to align and maximize opportunities provided by these channels for Abbott's glucose sensing technology. Set metrics to measure effectiveness of internal and external communication efforts. Coach senior divisional executives, businesses, regions and third-party spokespeople on delivery of key messages. EDUCATION AND EXPERIENCE YOU'LL BRING Required A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. 7+ years of experience in public relations and media relations, with a deep understanding of how to use external communications to enhance reputation. Preferred Experience in healthcare, technology and/or direct-to-consumer communications preferred. Strong contacts and working relationships with a variety of top tier media. Proven ability in placing media stories and managing relationships with U.S. top-tier technology, lifestyle, consumer and business media; experience with international media and media landscapes. Consistent track record of excellent professional writing, communication and project management skills. Strong experience in developing compelling content for product communications and developing key positioning, messaging, toolkits. Experience in working in a regulated environment. Able to achieve results while dealing with ambiguity, discretion, and a rapid pace of change. Experience working with and counseling senior management. Exhibits strong judgement and executive presence. Experience in crisis communication and exhibits anticipatory thinking. Proven experience in leading digital, social media and influencer projects to build brands. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on
09/11/2021
Full time
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our location in Alameda, California, currently has an opportunity for a Senior Manager, Public Affairs - Diabetes Care. The Public Affairs function for Abbott's diabetes care business has global responsibility for public relations activities for the world-leading sensing technology platform including FreeStyle Libre for people with diabetes and Abbott's Libre Sense Glucose Sport Biosensor designed for athletic performance. The successful candidate is passionate about consumer technology and its impact on human health. Seeking a candidate who is a strong storyteller in consumer, tech, and health, and has a proven-track record of top-tier media relations skills, can create compelling internal and external content, manage and anticipate crisis and issues, and develop international PR programming. The candidate will be self-motivated and nimble, thrive in a fast-paced dynamic environment, and have experience in supporting and executing successful PR and communications programs. Seeking a candidate with an ability to manage multiple projects across time zones, experience in working with other PR teams, agencies and has experience in managing crisis scenarios (pro-active and reactive), and supporting employee communications. The position will report directly to the the Head of Public Affairs for Abbott's diabetes care business. All division PA functions have a line reporting relationship to Corporate Public Affairs. WHAT YOU'LL DO Provide strategic counsel to marketing groups, internal/external clients, and country-level leadership on business-related efforts and initiatives; partner with various stakeholders including regulatory affairs, operations, quality, R&D, HR, government affairs, investor relations, legal, finance and senior management. Support the development and execution of external public relations strategies and approaches for key global product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. Work extensively with U.S. and international business, including affiliates and public affairs colleagues outside of the U.S. as well as agency partners. Assist director in developing plans, content, and supporting communication needs of country managers and affiliates around the world. Oversee PR agency management and/or PR agency selection process as needed. Work extensively with top-tier business, technology, lifestyle and consumer reporters (both proactively and reactively) to enhance and protect the company's reputation as well as advance business objectives. Develop compelling consumer-focused storylines, positioning and key messaging for the business. Assist with executive communications strategy and development of internal communication materials. Identify and anticipate issues and working with appropriate functions to counsel management on reputation/business impact and influence business decision making process. Develop multimedia, content and social and digital strategies to complement key Public Affairs campaigns. Bring to the table an understanding of today's communications environment amongst earned, owned, social and paid media and how to align and maximize opportunities provided by these channels for Abbott's glucose sensing technology. Set metrics to measure effectiveness of internal and external communication efforts. Coach senior divisional executives, businesses, regions and third-party spokespeople on delivery of key messages. EDUCATION AND EXPERIENCE YOU'LL BRING Required A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. 7+ years of experience in public relations and media relations, with a deep understanding of how to use external communications to enhance reputation. Preferred Experience in healthcare, technology and/or direct-to-consumer communications preferred. Strong contacts and working relationships with a variety of top tier media. Proven ability in placing media stories and managing relationships with U.S. top-tier technology, lifestyle, consumer and business media; experience with international media and media landscapes. Consistent track record of excellent professional writing, communication and project management skills. Strong experience in developing compelling content for product communications and developing key positioning, messaging, toolkits. Experience in working in a regulated environment. Able to achieve results while dealing with ambiguity, discretion, and a rapid pace of change. Experience working with and counseling senior management. Exhibits strong judgement and executive presence. Experience in crisis communication and exhibits anticipatory thinking. Proven experience in leading digital, social media and influencer projects to build brands. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
09/11/2021
Full time
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
Allogene Therapeutics
South San Francisco, California
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1
08/31/2021
Full time
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1