Beckman Coulter Diagnostics
Sacramento, California
Wondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Director, Director, R&D Assay Development, Microbiology for Beckman Coulter is responsible for strategic leadership of new product development and innovation platforms. This position will report directly to the VP of R&D based in Sacramento, CA. The successful candidate must have a strong R&D background and the ability to utilize the Danaher Business System Innovation process and tools to accelerate new product development projects to meet rapidly evolving customer needs. At Beckman Coulter, our vision to relentlessly reimagine healthcare, one diagnosis at a time. This position is part of the Microbiology department located in West Sacramento, CA and will be on site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. As part of the BEC Microbiology R&D leadership team, you will be responsible for collaborating closely with other members of the R&D, Quality, Regulatory, Clinical Affairs, Supply Chain, Product Management, and Program Management to drive operational excellence. If you thrive in a leadership role, are passionate about developing people and want to work developing novel solutions to address the global health threat of antimicrobial resistance, please read on. In this role, you will have the opportunity to: Collaborate with senior management to develop product portfolio strategies for the product lines. Drive robust and reliable product design, verification, and validation of initial and subsequent design changes, ensuring all FDA/ISO/EN and other related requirements are consistently met. Manage the execution of complex R&D product development projects using a strong assay and systems mindset, inclusive of hardware, software, fluidics, reagents, and biologics. Oversee product development and sustaining of on-market products, ensuring their reliability improvements to drive customer satisfaction. Establish and sustain a data-driven culture of accountability by incorporating Danaher Business System (DBS) tools into daily work and management, including DRS, PRTI, DSS, SDR, VPM, and CCPM. Ensure the R&D organization has the necessary talent and capabilities to execute priorities, expedite time to market, and meet cost targets. Build and develop a highly skilled, global, professional, and engaged team with strong technical capabilities, creativity, and leadership to achieve organizational goals. The essential requirements of the job include: Education: Advanced degree (Masters or Ph.D.) in bioengineering, fluidics, mechanical, electrical, software, or systems engineering. Experience and Knowledge: 14+ years of experience in product development, preferably in analytical, scientific, or diagnostic instrumentation, with 4+ years in R&D management, preferably in a regulated environment. Leadership: Strong people leader with accomplishments in organizational development and talent management. Lean Tools: Experience in lean tools, leading Kaizens, and being a certified practitioner in those tools. Regulatory Knowledge: Experience in product development in a regulated environment with knowledge of FDA CFR820 and ISO 13485. Effective problem solver and data-driven decision maker; results oriented; ability to perform and meet deadlines; clear communication both written and verbal. It would be a plus if you also possess previous experience in: Working with an Antimicrobial Susceptibility Testing Breakpoint setting organization such as CLSI The salary range OR the hourly range for this role is $200,000 - $230,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
04/27/2025
Full time
Wondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Director, Director, R&D Assay Development, Microbiology for Beckman Coulter is responsible for strategic leadership of new product development and innovation platforms. This position will report directly to the VP of R&D based in Sacramento, CA. The successful candidate must have a strong R&D background and the ability to utilize the Danaher Business System Innovation process and tools to accelerate new product development projects to meet rapidly evolving customer needs. At Beckman Coulter, our vision to relentlessly reimagine healthcare, one diagnosis at a time. This position is part of the Microbiology department located in West Sacramento, CA and will be on site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. As part of the BEC Microbiology R&D leadership team, you will be responsible for collaborating closely with other members of the R&D, Quality, Regulatory, Clinical Affairs, Supply Chain, Product Management, and Program Management to drive operational excellence. If you thrive in a leadership role, are passionate about developing people and want to work developing novel solutions to address the global health threat of antimicrobial resistance, please read on. In this role, you will have the opportunity to: Collaborate with senior management to develop product portfolio strategies for the product lines. Drive robust and reliable product design, verification, and validation of initial and subsequent design changes, ensuring all FDA/ISO/EN and other related requirements are consistently met. Manage the execution of complex R&D product development projects using a strong assay and systems mindset, inclusive of hardware, software, fluidics, reagents, and biologics. Oversee product development and sustaining of on-market products, ensuring their reliability improvements to drive customer satisfaction. Establish and sustain a data-driven culture of accountability by incorporating Danaher Business System (DBS) tools into daily work and management, including DRS, PRTI, DSS, SDR, VPM, and CCPM. Ensure the R&D organization has the necessary talent and capabilities to execute priorities, expedite time to market, and meet cost targets. Build and develop a highly skilled, global, professional, and engaged team with strong technical capabilities, creativity, and leadership to achieve organizational goals. The essential requirements of the job include: Education: Advanced degree (Masters or Ph.D.) in bioengineering, fluidics, mechanical, electrical, software, or systems engineering. Experience and Knowledge: 14+ years of experience in product development, preferably in analytical, scientific, or diagnostic instrumentation, with 4+ years in R&D management, preferably in a regulated environment. Leadership: Strong people leader with accomplishments in organizational development and talent management. Lean Tools: Experience in lean tools, leading Kaizens, and being a certified practitioner in those tools. Regulatory Knowledge: Experience in product development in a regulated environment with knowledge of FDA CFR820 and ISO 13485. Effective problem solver and data-driven decision maker; results oriented; ability to perform and meet deadlines; clear communication both written and verbal. It would be a plus if you also possess previous experience in: Working with an Antimicrobial Susceptibility Testing Breakpoint setting organization such as CLSI The salary range OR the hourly range for this role is $200,000 - $230,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
As Sr Director Corporate Outreach, you will provide strategic leadership and oversight for the development and implementation of strategies and programs to communicate the company's vision, performance, business objectives, culture and values to the public, outward facing customers, and other stakeholders. This role is pivotal in amplifying SNC's brand and reputation by leveraging recent successes and driving strategic initiatives to position the company as a trusted leader in innovation and industry excellence. You'll partner with internal and external parties to plan, develop, implement, and evaluate strategic external communications in support of thought leadership including speaking opportunities for SNC leaders, awards, and developing meaningful content in support of SNC's overarching business goals. Working in tandem with our Communications Office and WDC Office, you will help influence public opinion and policy decisions through strategic communications activities, correct inaccuracies, anticipate and manage crisis communications, act as one of our spokespersons, and develop relationships with media and advocacy organizations. As the Sr Director Corporate Outreach, you will be responsible for developing, managing, and executing comprehensive outreach programs to enhance the company's relationships with key corporate partners, stakeholders, and the broader business community. This position involves building and maintaining strong partnerships, driving corporate engagement initiatives, and promoting the company's mission, values, and objectives through effective communication and collaboration. The majority of your work will be in the National Capital Region. Our team is responsible for government affairs, international strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Responsibilities: 1. Strategic Initiatives & Momentum Building: • Capitalize on SNC's recent successes to drive strategic initiatives and enhance the company's visibility and reputation. • Identify and execute opportunities to sustain and grow momentum in the marketplace. 2. Thought Leadership & Relationship Building: • Identify and execute strategic thought leadership opportunities that support SNC's brand and objectives, including speaking opportunities for SNC leaders, awards, and strategic/meaningful content to support Thought Leadership and prepare them to execute • Build and maintain relationships with key thought leaders, think tanks, policymakers, industry influencers, and media representatives. • Facilitate trusted connections that align with SNC's strategic goals and connect SNC leadership with key organizations as speakers and industry experts. • Serve as an ambassador of SNC in the National Capital Region, representing the company to thought leaders, think tanks, customers, media, administration officials, and industry partners. • Identify organizations and memberships to enhance SNC's profile 3. Collaborate with internal teams to understand priorities and craft messaging that resonates with diverse stakeholders; Strengthen the SNC brand by showcasing program wins, past performance, and innovative solutions. Qualifications You Must Have: Bachelor's Degree in a related field of Study Relevant experience may substitute for required education Progressive knowledge and understanding of one or more of the following disciplines: public relations/affairs, communications, media Proven experience in the application of varied communications channels including brand, media, corporate, crisis, and internal Strong writing, editing and proofreading skills, with a knack for creative and engaging copywriting and a detailed eye for editing Mastery of the ability to manage complex situations, delegate authority, lead and inspire your team, drive innovative thinking, instill collaboration, drive for success, challenge status quo and demonstrate ability to adapt to dynamic situations Active Secret Clearance Qualifications We Prefer: Typically 12-15 years of relevant experience; 10+ years demonstrated communication program execution experience Higher-level degree may be considered in lieu of relevant experience Proven experience in thought leadership and strategic content development in support of overall brand, public relations, or strategic communications. diverse audiences. Strong network within the National Capital Region, including government, media, and industry leaders. Track record of building and sustaining momentum around organizational successes and initiatives. Deep understanding of the aerospace, defense, or technology sectors is highly preferred. Ability to obtain and maintain a Top Secret Clearance Skills & Competencies: Strategic thinker with a results-oriented mindset Exceptional interpersonal and networking abilities Proficiency in leveraging media and digital platforms to amplify brand presence Ability to manage complex stakeholder relationships with tact and diplomacy Highly organized, creative, articulate and possess excellent people skills Ability to work flexible hours & travel when necessary Public Relations Certification At Sierra Nevada Corporation (SNC) we deliver customer-focused technology and best-of-breed integrations in the aerospace and defense sectors. SNC has been honored as one of the most innovative U.S. companies in space, a Tier One Superior Supplier for the U.S. Air Force, and as one of America's fastest-growing companies. Learn more about SNC SNC offers annual incentive pay based upon performance that is commensurate with the level of the position. SNC offers a generous benefit package, including medical, dental, and vision plans, 401(k) with 150% match up to 6%, life insurance, 3 weeks paid time off, tuition reimbursement, and more . IMPORTANT NOTICE: This position requires current/active Secret U.S. Security Clearance. U.S. Citizenship status is required as this position needs an active U.S. Security Clearance for employment. Non-U.S. Citizens may not be eligible to obtain a security clearance. The Department of Defense Consolidated Adjudications Facility (DoD CAF), a federal government agency, handles the adjudicative aspects of the security clearance eligibility process for industry applicants. Adjudicative factors which affect the outcome of the eligibility determination include, but are not limited to, allegiance to the U.S., foreign influence, foreign preference, criminal conduct, security violations and illegal drug use. Learn more about the background check process for Security Clearances. SNC is a global leader in aerospace and national security committed to moving the American Dream forward. We're known and respected for our mission and execution focus, agility, and disruptive and rapid innovation. We provide leading edge technologies and transformative solutions that support our nation's most critical security needs. If you are mission-focused, thrive in collaborative environments, and want to make our country stronger with state-of-the-art technologies that safeguard freedom, join our team! SNC is an Equal Opportunity Employer committed to an environment free of discrimination. Employment decisions are made based on merit without regard to race, color, age, religion, sex, national origin, disability, status as a protected veteran or other characteristics protected by law.
04/26/2025
Full time
As Sr Director Corporate Outreach, you will provide strategic leadership and oversight for the development and implementation of strategies and programs to communicate the company's vision, performance, business objectives, culture and values to the public, outward facing customers, and other stakeholders. This role is pivotal in amplifying SNC's brand and reputation by leveraging recent successes and driving strategic initiatives to position the company as a trusted leader in innovation and industry excellence. You'll partner with internal and external parties to plan, develop, implement, and evaluate strategic external communications in support of thought leadership including speaking opportunities for SNC leaders, awards, and developing meaningful content in support of SNC's overarching business goals. Working in tandem with our Communications Office and WDC Office, you will help influence public opinion and policy decisions through strategic communications activities, correct inaccuracies, anticipate and manage crisis communications, act as one of our spokespersons, and develop relationships with media and advocacy organizations. As the Sr Director Corporate Outreach, you will be responsible for developing, managing, and executing comprehensive outreach programs to enhance the company's relationships with key corporate partners, stakeholders, and the broader business community. This position involves building and maintaining strong partnerships, driving corporate engagement initiatives, and promoting the company's mission, values, and objectives through effective communication and collaboration. The majority of your work will be in the National Capital Region. Our team is responsible for government affairs, international strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Responsibilities: 1. Strategic Initiatives & Momentum Building: • Capitalize on SNC's recent successes to drive strategic initiatives and enhance the company's visibility and reputation. • Identify and execute opportunities to sustain and grow momentum in the marketplace. 2. Thought Leadership & Relationship Building: • Identify and execute strategic thought leadership opportunities that support SNC's brand and objectives, including speaking opportunities for SNC leaders, awards, and strategic/meaningful content to support Thought Leadership and prepare them to execute • Build and maintain relationships with key thought leaders, think tanks, policymakers, industry influencers, and media representatives. • Facilitate trusted connections that align with SNC's strategic goals and connect SNC leadership with key organizations as speakers and industry experts. • Serve as an ambassador of SNC in the National Capital Region, representing the company to thought leaders, think tanks, customers, media, administration officials, and industry partners. • Identify organizations and memberships to enhance SNC's profile 3. Collaborate with internal teams to understand priorities and craft messaging that resonates with diverse stakeholders; Strengthen the SNC brand by showcasing program wins, past performance, and innovative solutions. Qualifications You Must Have: Bachelor's Degree in a related field of Study Relevant experience may substitute for required education Progressive knowledge and understanding of one or more of the following disciplines: public relations/affairs, communications, media Proven experience in the application of varied communications channels including brand, media, corporate, crisis, and internal Strong writing, editing and proofreading skills, with a knack for creative and engaging copywriting and a detailed eye for editing Mastery of the ability to manage complex situations, delegate authority, lead and inspire your team, drive innovative thinking, instill collaboration, drive for success, challenge status quo and demonstrate ability to adapt to dynamic situations Active Secret Clearance Qualifications We Prefer: Typically 12-15 years of relevant experience; 10+ years demonstrated communication program execution experience Higher-level degree may be considered in lieu of relevant experience Proven experience in thought leadership and strategic content development in support of overall brand, public relations, or strategic communications. diverse audiences. Strong network within the National Capital Region, including government, media, and industry leaders. Track record of building and sustaining momentum around organizational successes and initiatives. Deep understanding of the aerospace, defense, or technology sectors is highly preferred. Ability to obtain and maintain a Top Secret Clearance Skills & Competencies: Strategic thinker with a results-oriented mindset Exceptional interpersonal and networking abilities Proficiency in leveraging media and digital platforms to amplify brand presence Ability to manage complex stakeholder relationships with tact and diplomacy Highly organized, creative, articulate and possess excellent people skills Ability to work flexible hours & travel when necessary Public Relations Certification At Sierra Nevada Corporation (SNC) we deliver customer-focused technology and best-of-breed integrations in the aerospace and defense sectors. SNC has been honored as one of the most innovative U.S. companies in space, a Tier One Superior Supplier for the U.S. Air Force, and as one of America's fastest-growing companies. Learn more about SNC SNC offers annual incentive pay based upon performance that is commensurate with the level of the position. SNC offers a generous benefit package, including medical, dental, and vision plans, 401(k) with 150% match up to 6%, life insurance, 3 weeks paid time off, tuition reimbursement, and more . IMPORTANT NOTICE: This position requires current/active Secret U.S. Security Clearance. U.S. Citizenship status is required as this position needs an active U.S. Security Clearance for employment. Non-U.S. Citizens may not be eligible to obtain a security clearance. The Department of Defense Consolidated Adjudications Facility (DoD CAF), a federal government agency, handles the adjudicative aspects of the security clearance eligibility process for industry applicants. Adjudicative factors which affect the outcome of the eligibility determination include, but are not limited to, allegiance to the U.S., foreign influence, foreign preference, criminal conduct, security violations and illegal drug use. Learn more about the background check process for Security Clearances. SNC is a global leader in aerospace and national security committed to moving the American Dream forward. We're known and respected for our mission and execution focus, agility, and disruptive and rapid innovation. We provide leading edge technologies and transformative solutions that support our nation's most critical security needs. If you are mission-focused, thrive in collaborative environments, and want to make our country stronger with state-of-the-art technologies that safeguard freedom, join our team! SNC is an Equal Opportunity Employer committed to an environment free of discrimination. Employment decisions are made based on merit without regard to race, color, age, religion, sex, national origin, disability, status as a protected veteran or other characteristics protected by law.
As Sr Director Government Relations, you will drive initiatives to support the development and implementation of corporate policy through strategic partnerships with government and industry groups. You'll be responsible for representing the company on Navy related Government Affairs with elected officials and government officials in regulatory agencies and ensure appropriate company participation in maritime forums and industry group meetings. You'll develop key relationships with designated trade and business associations, and advocacy groups on maritime regulatory issues of importance to the company and ensure communications on behalf of the company are clear and consistent. You'll also monitor federal proposals to support the assessment of naval opportunities available within and beyond our existing markets, offerings and business models. Our team is responsible for government affairs, legislative strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Our team is responsible for government affairs, international strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Qualifications You Must Have: Bachelor's Degree in a related field of study Relevant experience may be considered in lieu of required education Familiarity and experience with naval operational and acquisition organizations including COCOMS, SYSCOMS (NAVWAR, NAVSEA, NAVAIR, MCSC), PEOs and OPNAV. Working knowledge and experience with government relations and affairs, Department of Defense budgeting process, or industry Business Development efforts. Experience serving as the liaison between a corporation and government with experience effectively communicating with senior executives. Technical understanding of current and emerging maritime capabilities Ability to possess a strategic mindset to navigate, affect, and/or lead complex initiatives with senior-level stakeholders Strong interpersonal and written/verbal communication skills; ability to establish and develop relationships, coalitions, and partnerships with ease The ability to obtain and maintain a Secret U.S. Security Clearance is required Qualifications We Prefer: Typically 12-15 years of relevant experience in maritime domain; 10 years of Navy military service Background in the US Navy or the US Department of Defense (Civilian), Aerospace and Defense Industry, with an understanding of maritime defense, aerospace, and intelligence markets Domain knowledge of JADC2 and familiarity with Project Overmatch and Information Warfare a plus SNC offers annual incentive pay based upon performance that is commensurate with the level of the position. SNC offers a generous benefit package, including medical, dental, and vision plans, 401(k) with 150% match up to 6%, life insurance, 3 weeks paid time off, tuition reimbursement, and more . IMPORTANT NOTICE: This position requires the ability to obtain and maintain a Secret U.S. Security Clearance. U.S. Citizenship status is required as this position needs an active U.S. Security Clearance for employment. Non-U.S. citizens may not be eligible to obtain a security clearance. The Department of Defense Consolidated Adjudications Facility (DoD CAF), a federal government agency, handles the adjudicative aspects of the security clearance eligibility process for industry applicants. Adjudicative factors which affect the outcome of the eligibility determination include, but are not limited to, allegiance to the U.S., foreign influence, foreign preference, criminal conduct, security violations and illegal drug use. Learn more about the background check process for Security Clearances. SNC is a global leader in aerospace and national security committed to moving the American Dream forward. We're known and respected for our mission and execution focus, agility, and disruptive and rapid innovation. We provide leading edge technologies and transformative solutions that support our nation's most critical security needs. If you are mission-focused, thrive in collaborative environments, and want to make our country stronger with state-of-the-art technologies that safeguard freedom, join our team! SNC is an Equal Opportunity Employer committed to an environment free of discrimination. Employment decisions are made based on merit without regard to race, color, age, religion, sex, national origin, disability, status as a protected veteran or other characteristics protected by law.
04/26/2025
Full time
As Sr Director Government Relations, you will drive initiatives to support the development and implementation of corporate policy through strategic partnerships with government and industry groups. You'll be responsible for representing the company on Navy related Government Affairs with elected officials and government officials in regulatory agencies and ensure appropriate company participation in maritime forums and industry group meetings. You'll develop key relationships with designated trade and business associations, and advocacy groups on maritime regulatory issues of importance to the company and ensure communications on behalf of the company are clear and consistent. You'll also monitor federal proposals to support the assessment of naval opportunities available within and beyond our existing markets, offerings and business models. Our team is responsible for government affairs, legislative strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Our team is responsible for government affairs, international strategy, international business, and trade and regulatory compliance. We provide strategic guidance across the organization, helping to find alignment and compliance between SNC and the national security priorities of the U.S. government. Qualifications You Must Have: Bachelor's Degree in a related field of study Relevant experience may be considered in lieu of required education Familiarity and experience with naval operational and acquisition organizations including COCOMS, SYSCOMS (NAVWAR, NAVSEA, NAVAIR, MCSC), PEOs and OPNAV. Working knowledge and experience with government relations and affairs, Department of Defense budgeting process, or industry Business Development efforts. Experience serving as the liaison between a corporation and government with experience effectively communicating with senior executives. Technical understanding of current and emerging maritime capabilities Ability to possess a strategic mindset to navigate, affect, and/or lead complex initiatives with senior-level stakeholders Strong interpersonal and written/verbal communication skills; ability to establish and develop relationships, coalitions, and partnerships with ease The ability to obtain and maintain a Secret U.S. Security Clearance is required Qualifications We Prefer: Typically 12-15 years of relevant experience in maritime domain; 10 years of Navy military service Background in the US Navy or the US Department of Defense (Civilian), Aerospace and Defense Industry, with an understanding of maritime defense, aerospace, and intelligence markets Domain knowledge of JADC2 and familiarity with Project Overmatch and Information Warfare a plus SNC offers annual incentive pay based upon performance that is commensurate with the level of the position. SNC offers a generous benefit package, including medical, dental, and vision plans, 401(k) with 150% match up to 6%, life insurance, 3 weeks paid time off, tuition reimbursement, and more . IMPORTANT NOTICE: This position requires the ability to obtain and maintain a Secret U.S. Security Clearance. U.S. Citizenship status is required as this position needs an active U.S. Security Clearance for employment. Non-U.S. citizens may not be eligible to obtain a security clearance. The Department of Defense Consolidated Adjudications Facility (DoD CAF), a federal government agency, handles the adjudicative aspects of the security clearance eligibility process for industry applicants. Adjudicative factors which affect the outcome of the eligibility determination include, but are not limited to, allegiance to the U.S., foreign influence, foreign preference, criminal conduct, security violations and illegal drug use. Learn more about the background check process for Security Clearances. SNC is a global leader in aerospace and national security committed to moving the American Dream forward. We're known and respected for our mission and execution focus, agility, and disruptive and rapid innovation. We provide leading edge technologies and transformative solutions that support our nation's most critical security needs. If you are mission-focused, thrive in collaborative environments, and want to make our country stronger with state-of-the-art technologies that safeguard freedom, join our team! SNC is an Equal Opportunity Employer committed to an environment free of discrimination. Employment decisions are made based on merit without regard to race, color, age, religion, sex, national origin, disability, status as a protected veteran or other characteristics protected by law.
The Office for Finance is committed to fulfilling Santa Fe College's mission by providing the highest quality fiscal services through excellence in customer service, integrity, accountability, and stewardship, working together to implement creative solutions and best practices in sustainability and diversity. The Grant Compliance Manager is responsible for overseeing and ensuring compliance in the administration of post-award grant activities for private, state, and federal grants. The Manager safeguards regulatory adherence, aligning grant management practices with college funding sources, administrative procedures, and policies. The Manager also provides guidance and support to appropriate staff on grant development, compliance, and administration, ensuring the effective and compliant execution of grant-funded initiatives in accordance with all applicable federal, state and local regulations. Job Description Responsibilities and Duties Include: Leads, coordinates, monitors, and tracks compliance efforts and effective grant management processes with grant coordinators and directors, administrators, the sponsored projects team, and other college staff involved in grant projects. Manages and monitors all assigned projects to determine eligibility status and to ensure compliance with grant and/or contract requirements. Ensures compliance throughout the entire grant cycle, from pre- to post-award, while adhering to all regulatory and institutional requirements. Reviews, interprets, and understands the laws, regulations, and guidelines set by federal and state authorities, as well as specific requirements outlined by the funding organization for each grant. May assist with grant applications by providing recommendations that enhance proposal competitiveness and maintain the integrity of college resources. Provides guidance during the evaluation process and reviews grant proposal budgets prior to submission to ensure expenditures are linked to the programmatic goals and objectives of the grant. Supports grant coordinators and directors with the completion of annual reports, budget modifications, subcontracts, forms and correspondence to ensure accuracy and compliance. Communicates with funding organizations, submits required documentation, and secures approval for any changes to the scope of budget or grants. Supports the Director of Sponsored Projects (SPO) and applicable staff on closeout efforts and maintains regulatory file copies of all grants; maintains grant project filing systems. Maintains consistent, professional communications with grant coordinators and directors, office for finance and sponsored projects staff, and other college constituents to report progress towards meeting objectives and address any grant management compliance issues. Conducts meetings with grant coordinators and directors to review progress, address concerns and ensure ongoing compliance; maintains detailed records to support grant documentation and reporting. Responds to complex inquiries from all levels of employees and/or external sources regarding a variety of questions, such as clarification of college policies and procedures as it relates to grant management and compliance. Monitors progress towards meeting grant objectives and submits reports to administrators, internal auditors, SPO Director, and CFO; submits monthly summary reports to appropriate administrators. Provides administrative support to funded projects, including serving on post-award committees, to ensure compliance and successful project implementation. Develops training materials for administration, faculty, and staff on grant compliance rules and regulations; designs and delivers introductory grant training sessions. Maintains professional and collaborative relationships with Student Affairs, Academic Affairs, Sponsored Projects Office, and other college constituents. Learns and maintains knowledge of college rules and policies, grant policies and procedures, federal and state rules and regulations, accounting functions, and funding agency required documentation. Attends and participates in professional development training opportunities to remain current in grant compliance, management, and development topics. Complies with all published College Rules, procedures, guidelines, and laws/regulations governing public employees, including but not limited to those related to document retention and destruction, FERPA, and confidentiality. Strictly honors the privacy, security, and confidentiality of student records and other sensitive information according to appropriate state, federal, and college regulations, policies, and procedures. Provides service excellence through courteous, informed, accessible, and professional engagement. Performs other duties as assigned. QUALIFICATIONS Required: A bachelor's degree in areas of business, accounting, finance, public administration, legal services, or related fields with two (2) years of experience in project management and/or grant compliance, or a combination of completed education and/or experience equal to six (6) years. Additional Requirements: A criminal background check will be conducted. Preferred: Certified Grants Management Specialist designation from the National Grants Management Association (NGMA); a master's degree with work experience in implementing and managing grants. General Knowledge, Skills, and Abilities Ability to work successfully in a multi-cultural environment. Adaptability to Change - able to be flexible and supportive, able to positively and proactively assimilate change in rapid growth environment. Analytical Aptitude & Problem Solving - able to analyze information, problems, situations, practices and/or procedures, collect and interpret data, reason logically, establish facts, identify and define existing and potential issues, recognize the interrelationships among elements, draw valid conclusions, develop recommendations, as well as alternative courses of action, select appropriate course, follow up, and evaluate. Communication - able to effectively communicate in a professional, diplomatic, empathetic, and tactful manner using preferred method and level as applicable to the job. Critical Thinking & Judgement - able to make well-reasoned, sensible, and timely decisions based on careful, objective review and informed analysis of available information, considerations, and other factors. Customer Service - ability to respond promptly and courteously to all questions from students and faculty, demonstrating patience and persistence when helping students with little or no computer skills. Ethics - able to demonstrate integrity, professionalism, civility, and a high degree of ethics in all job-related actions. Organization & Time Management - able to plan, schedule, and organize tasks related to the job to achieve goals within or ahead of established time frames. Problem Solving - proven skills in identifying issues, determining their cause, developing creative solutions, and following through with implementing resolutions. Team Orientation & Interpersonal - highly motivated team-player with ability to develop and maintain collaborative relationships with all levels within and external to the organization. Relationship Management - able to personally provide high level of interactive service to others, building relationships and addressing identified needs. Results Orientation - proven ability to set and exceed established targets. Systems & Software - proficient level of knowledge of Microsoft Office and/or relevant position software programs. Detail Oriented - Proven accuracy and attention to detail. Multi-task - Ability to expeditiously organize, coordinate, manage, prioritize, and perform multiple tasks simultaneously to swiftly assess a situation, determine a logical course of action, and apply the appropriate response. Application Process: All applicants must submit a completed online SF application, a letter of intent, an up-to-date resume/curriculum vitae, and unofficial academic transcripts (if applicable) to be considered for this position. Unofficial transcripts are only accepted for review purposes, official transcripts are required prior to any offer of employment being made.
04/26/2025
Full time
The Office for Finance is committed to fulfilling Santa Fe College's mission by providing the highest quality fiscal services through excellence in customer service, integrity, accountability, and stewardship, working together to implement creative solutions and best practices in sustainability and diversity. The Grant Compliance Manager is responsible for overseeing and ensuring compliance in the administration of post-award grant activities for private, state, and federal grants. The Manager safeguards regulatory adherence, aligning grant management practices with college funding sources, administrative procedures, and policies. The Manager also provides guidance and support to appropriate staff on grant development, compliance, and administration, ensuring the effective and compliant execution of grant-funded initiatives in accordance with all applicable federal, state and local regulations. Job Description Responsibilities and Duties Include: Leads, coordinates, monitors, and tracks compliance efforts and effective grant management processes with grant coordinators and directors, administrators, the sponsored projects team, and other college staff involved in grant projects. Manages and monitors all assigned projects to determine eligibility status and to ensure compliance with grant and/or contract requirements. Ensures compliance throughout the entire grant cycle, from pre- to post-award, while adhering to all regulatory and institutional requirements. Reviews, interprets, and understands the laws, regulations, and guidelines set by federal and state authorities, as well as specific requirements outlined by the funding organization for each grant. May assist with grant applications by providing recommendations that enhance proposal competitiveness and maintain the integrity of college resources. Provides guidance during the evaluation process and reviews grant proposal budgets prior to submission to ensure expenditures are linked to the programmatic goals and objectives of the grant. Supports grant coordinators and directors with the completion of annual reports, budget modifications, subcontracts, forms and correspondence to ensure accuracy and compliance. Communicates with funding organizations, submits required documentation, and secures approval for any changes to the scope of budget or grants. Supports the Director of Sponsored Projects (SPO) and applicable staff on closeout efforts and maintains regulatory file copies of all grants; maintains grant project filing systems. Maintains consistent, professional communications with grant coordinators and directors, office for finance and sponsored projects staff, and other college constituents to report progress towards meeting objectives and address any grant management compliance issues. Conducts meetings with grant coordinators and directors to review progress, address concerns and ensure ongoing compliance; maintains detailed records to support grant documentation and reporting. Responds to complex inquiries from all levels of employees and/or external sources regarding a variety of questions, such as clarification of college policies and procedures as it relates to grant management and compliance. Monitors progress towards meeting grant objectives and submits reports to administrators, internal auditors, SPO Director, and CFO; submits monthly summary reports to appropriate administrators. Provides administrative support to funded projects, including serving on post-award committees, to ensure compliance and successful project implementation. Develops training materials for administration, faculty, and staff on grant compliance rules and regulations; designs and delivers introductory grant training sessions. Maintains professional and collaborative relationships with Student Affairs, Academic Affairs, Sponsored Projects Office, and other college constituents. Learns and maintains knowledge of college rules and policies, grant policies and procedures, federal and state rules and regulations, accounting functions, and funding agency required documentation. Attends and participates in professional development training opportunities to remain current in grant compliance, management, and development topics. Complies with all published College Rules, procedures, guidelines, and laws/regulations governing public employees, including but not limited to those related to document retention and destruction, FERPA, and confidentiality. Strictly honors the privacy, security, and confidentiality of student records and other sensitive information according to appropriate state, federal, and college regulations, policies, and procedures. Provides service excellence through courteous, informed, accessible, and professional engagement. Performs other duties as assigned. QUALIFICATIONS Required: A bachelor's degree in areas of business, accounting, finance, public administration, legal services, or related fields with two (2) years of experience in project management and/or grant compliance, or a combination of completed education and/or experience equal to six (6) years. Additional Requirements: A criminal background check will be conducted. Preferred: Certified Grants Management Specialist designation from the National Grants Management Association (NGMA); a master's degree with work experience in implementing and managing grants. General Knowledge, Skills, and Abilities Ability to work successfully in a multi-cultural environment. Adaptability to Change - able to be flexible and supportive, able to positively and proactively assimilate change in rapid growth environment. Analytical Aptitude & Problem Solving - able to analyze information, problems, situations, practices and/or procedures, collect and interpret data, reason logically, establish facts, identify and define existing and potential issues, recognize the interrelationships among elements, draw valid conclusions, develop recommendations, as well as alternative courses of action, select appropriate course, follow up, and evaluate. Communication - able to effectively communicate in a professional, diplomatic, empathetic, and tactful manner using preferred method and level as applicable to the job. Critical Thinking & Judgement - able to make well-reasoned, sensible, and timely decisions based on careful, objective review and informed analysis of available information, considerations, and other factors. Customer Service - ability to respond promptly and courteously to all questions from students and faculty, demonstrating patience and persistence when helping students with little or no computer skills. Ethics - able to demonstrate integrity, professionalism, civility, and a high degree of ethics in all job-related actions. Organization & Time Management - able to plan, schedule, and organize tasks related to the job to achieve goals within or ahead of established time frames. Problem Solving - proven skills in identifying issues, determining their cause, developing creative solutions, and following through with implementing resolutions. Team Orientation & Interpersonal - highly motivated team-player with ability to develop and maintain collaborative relationships with all levels within and external to the organization. Relationship Management - able to personally provide high level of interactive service to others, building relationships and addressing identified needs. Results Orientation - proven ability to set and exceed established targets. Systems & Software - proficient level of knowledge of Microsoft Office and/or relevant position software programs. Detail Oriented - Proven accuracy and attention to detail. Multi-task - Ability to expeditiously organize, coordinate, manage, prioritize, and perform multiple tasks simultaneously to swiftly assess a situation, determine a logical course of action, and apply the appropriate response. Application Process: All applicants must submit a completed online SF application, a letter of intent, an up-to-date resume/curriculum vitae, and unofficial academic transcripts (if applicable) to be considered for this position. Unofficial transcripts are only accepted for review purposes, official transcripts are required prior to any offer of employment being made.
Sr. Engineer & Principal Eng/Ops Project Manager - Portland, Oregon Date: Apr 25, 2025 Location: PORTLAND, OR, US, 97232 Company: PacifiCorp POWER YOUR GREATNESS! PacifiCorp is seeking customer-centric candidates to grow and sustain our commitment to a culture of customer service excellence, environmental sustainability, inclusion and belonging. General Purpose With minimal direction from a department manager, a program manager, or the director of engineering/operations (project management office), oversees high-risk projects, which require considerable resources and high levels of functional integration. In addition to having responsibility for all aspects of the project over the entire project life (initiate, plan, execute, control, close), assembling project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of assigned projects, takes projects from original concept through final implementation. Responsibilities Responsibilities of this position include the following: Manage the planning, development and design of multiple large scale capital projects (e.g. modifications/additions to facilities and infrastructure) under minimal supervision and coordinate with construction team as projects are brought to commercial operation. Establish, track, and control project cost, scope, schedule, and risk to deliver assigned projects within their approved scope, budget, and schedule. Plan, schedule, and execute multiple phases of projects in accordance with project management processes, policies and guidelines, and corporate governance. Develop detailed project plans and schedules tonsure project scopes, team responsibilities, milestone dates, and the procurement strategy are clearly stated for all assigned projects. Coordinate the development of feasibility studies, conceptual and detailed designs, and work with construction project managers to ensure projects meet development constraints and objectives. Develop and execute public involvement plan during the project permitting phase. Interface with external customers throughout the project life cycle. Provide project progress reports to management and other stakeholders in accordance with an established communication plan. Provide accurate project cost forecasting over the life of the project. Coordinate with procurement to solicit external materials and services as required for project deliverables. Manage the bid process, and contracts for external engineering services. Interface with appropriate management levels including senior management to gain necessary approvals and manage risk in accordance with corporate governance. Additional Responsibilities of the Principal Eng/Ops Project Manager position include the following: Manage the most complex, high-risk and politically sensitive capital projects from assignment to closeout and direct project teams to ensure all phases of projects meet cost, schedule, and quality requirements. Coordinate and direct the activities of as many as (20) internal departments including regulatory affairs, general counsel and customer & community affairs and as many as (15) external government and private agencies including Public Utility Commissions and other utilities in the process of delivering assigned projects. Define and manage interfaces with senior management, business units, regulators, contractors, vendors, customers, and auditors on assigned projects. Manage the development of conceptual and detailed designs. Monitor the scope, cost, and schedule for variances and implement corrective measures. Provide project progress reports to management and other stakeholders in accordance with an approved communication plan. Provide accurate project cost forecasting over the life of the project. Develop scopes of work and requests for proposals for external multimillion dollar engineer, procure, construct contracts as necessary. Manage the tracking, expediting, and completion of material and equipment orders. Provide leadership regarding project management practices and issue resolution. May have direct supervisory responsibility for a project team. Requirements Requirements for this position include the following: Bachelors Degree in, Engineering, Construction Management, Business Administration or the equivalent combination of education and experience Five years related professional experience. Proficient in project scheduling, cost controls, tracking and reporting methodologies. Knowledge of financial principles to quantify costs and benefits of projects and to track and maintain project budgets Proficient in the application of Project Management Institute project management techniques or equivalent Experience in managing vendors and contractors regarding work scope changes to ensure that all contract commitments are completed on time per applicable specifications Excellent presentation, technical writing and verbal communication skills Demonstrated business management skills including consulting skills, customer service, and business acumen Interpersonal and communication skills to facilitate team efforts, provide guidance and direction to team members, and communicate project objectives, parameters, status, and outcomes to stakeholders Ability to analyze information, conduct engineering analysis and develop economic analysis inputs, form conclusions and provide meaningful and creative solutions to non-typical business issues Ability to document and describe project decisions and rationale with excellent written communication Demonstrated skill in motivating and influencing others as well as skills and experience in team building and conflict management Proficient in using Microsoft Office Suite including Word and Excel Additional Requirements of the Principal Eng/Ops Project Manager position include the following: Ten years related professional experience. Proficient in financial principles to quantify costs and benefits of projects and to track and maintain project budgets Expert in the application of Project Management Institute project management techniques or equivalent Demonstrated advanced business management skills including consulting skills, customer service, and business acumen Excellent interpersonal and communication skills to facilitate team efforts, provide guidance and direction to team members, and communicate project objectives, parameters, status, and outcomes to stakeholders Highly skilled in motivating and influencing others, experience in team building and conflict management Ability to analyze information, form conclusions and provide meaningful and creative solutions to non-typical business issues Preferences Seven years related professional experience. Masters in Business Administration or advanced Engineering or other technical degree Current Professional Engineer License Project Management Professional certification by the Project Management Institute, or Advanced Project Management, or Program Management Certification Understanding of environmental regulations, National Environmental Protection Act, environmental impact statement, environmental assessment, State Historical Preservation Office/Section 106 requirements, Army Corp of Engineers Section 404 permitting, Energy Facility Permitting, federal SF-299 right of way reservation process, etc. Knowledge of the Companys business, policies, procedures, and practices Demonstrated experience in the development, construction, operation and maintenance of large energy infrastructure projects, including familiarity with renewable energy technologies including wind, solar, storage and thermal gas generation Experience in the electric utility industry, resource development, and applicable federal, state and local regulations and permit processes Working knowledge of SAP in cost tracking and forecasting Working knowledge of Primavera scheduling or other project management software Experience in electric utility design and/or construction Preference for the Principal Eng/Ops Project Manager will be given to candidates who have the following: Masters in Business Administration or advanced Engineering or other technical degree Current Professional Engineer License Advanced Project Management or Program Management Certification by the Project Management Institute Understanding of environmental regulations, National Environmental Protection Act, environmental impact statement, environmental assessment, State Historical Preservation Office, Army Corp of Engineers, etc. Knowledge of the Companys business, policies, procedures, and practices Experience in the electric utility industry and applicable federal, state and local regulations. Experience in managing direct reports. Additional Information Req Id: 113556 Company Code: PACIFICORP Primary Location: Portland, Oregon Department: Strategy & Resource Dev Schedule: Full - Time Personnel Subarea: Exempt Hiring Range: 119,400 - 177,300 This position is eligible for an annual discretionary performance incentive bonus of up to 15.00% of salary. Benefits: Health care . click apply for full job details
04/26/2025
Full time
Sr. Engineer & Principal Eng/Ops Project Manager - Portland, Oregon Date: Apr 25, 2025 Location: PORTLAND, OR, US, 97232 Company: PacifiCorp POWER YOUR GREATNESS! PacifiCorp is seeking customer-centric candidates to grow and sustain our commitment to a culture of customer service excellence, environmental sustainability, inclusion and belonging. General Purpose With minimal direction from a department manager, a program manager, or the director of engineering/operations (project management office), oversees high-risk projects, which require considerable resources and high levels of functional integration. In addition to having responsibility for all aspects of the project over the entire project life (initiate, plan, execute, control, close), assembling project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of assigned projects, takes projects from original concept through final implementation. Responsibilities Responsibilities of this position include the following: Manage the planning, development and design of multiple large scale capital projects (e.g. modifications/additions to facilities and infrastructure) under minimal supervision and coordinate with construction team as projects are brought to commercial operation. Establish, track, and control project cost, scope, schedule, and risk to deliver assigned projects within their approved scope, budget, and schedule. Plan, schedule, and execute multiple phases of projects in accordance with project management processes, policies and guidelines, and corporate governance. Develop detailed project plans and schedules tonsure project scopes, team responsibilities, milestone dates, and the procurement strategy are clearly stated for all assigned projects. Coordinate the development of feasibility studies, conceptual and detailed designs, and work with construction project managers to ensure projects meet development constraints and objectives. Develop and execute public involvement plan during the project permitting phase. Interface with external customers throughout the project life cycle. Provide project progress reports to management and other stakeholders in accordance with an established communication plan. Provide accurate project cost forecasting over the life of the project. Coordinate with procurement to solicit external materials and services as required for project deliverables. Manage the bid process, and contracts for external engineering services. Interface with appropriate management levels including senior management to gain necessary approvals and manage risk in accordance with corporate governance. Additional Responsibilities of the Principal Eng/Ops Project Manager position include the following: Manage the most complex, high-risk and politically sensitive capital projects from assignment to closeout and direct project teams to ensure all phases of projects meet cost, schedule, and quality requirements. Coordinate and direct the activities of as many as (20) internal departments including regulatory affairs, general counsel and customer & community affairs and as many as (15) external government and private agencies including Public Utility Commissions and other utilities in the process of delivering assigned projects. Define and manage interfaces with senior management, business units, regulators, contractors, vendors, customers, and auditors on assigned projects. Manage the development of conceptual and detailed designs. Monitor the scope, cost, and schedule for variances and implement corrective measures. Provide project progress reports to management and other stakeholders in accordance with an approved communication plan. Provide accurate project cost forecasting over the life of the project. Develop scopes of work and requests for proposals for external multimillion dollar engineer, procure, construct contracts as necessary. Manage the tracking, expediting, and completion of material and equipment orders. Provide leadership regarding project management practices and issue resolution. May have direct supervisory responsibility for a project team. Requirements Requirements for this position include the following: Bachelors Degree in, Engineering, Construction Management, Business Administration or the equivalent combination of education and experience Five years related professional experience. Proficient in project scheduling, cost controls, tracking and reporting methodologies. Knowledge of financial principles to quantify costs and benefits of projects and to track and maintain project budgets Proficient in the application of Project Management Institute project management techniques or equivalent Experience in managing vendors and contractors regarding work scope changes to ensure that all contract commitments are completed on time per applicable specifications Excellent presentation, technical writing and verbal communication skills Demonstrated business management skills including consulting skills, customer service, and business acumen Interpersonal and communication skills to facilitate team efforts, provide guidance and direction to team members, and communicate project objectives, parameters, status, and outcomes to stakeholders Ability to analyze information, conduct engineering analysis and develop economic analysis inputs, form conclusions and provide meaningful and creative solutions to non-typical business issues Ability to document and describe project decisions and rationale with excellent written communication Demonstrated skill in motivating and influencing others as well as skills and experience in team building and conflict management Proficient in using Microsoft Office Suite including Word and Excel Additional Requirements of the Principal Eng/Ops Project Manager position include the following: Ten years related professional experience. Proficient in financial principles to quantify costs and benefits of projects and to track and maintain project budgets Expert in the application of Project Management Institute project management techniques or equivalent Demonstrated advanced business management skills including consulting skills, customer service, and business acumen Excellent interpersonal and communication skills to facilitate team efforts, provide guidance and direction to team members, and communicate project objectives, parameters, status, and outcomes to stakeholders Highly skilled in motivating and influencing others, experience in team building and conflict management Ability to analyze information, form conclusions and provide meaningful and creative solutions to non-typical business issues Preferences Seven years related professional experience. Masters in Business Administration or advanced Engineering or other technical degree Current Professional Engineer License Project Management Professional certification by the Project Management Institute, or Advanced Project Management, or Program Management Certification Understanding of environmental regulations, National Environmental Protection Act, environmental impact statement, environmental assessment, State Historical Preservation Office/Section 106 requirements, Army Corp of Engineers Section 404 permitting, Energy Facility Permitting, federal SF-299 right of way reservation process, etc. Knowledge of the Companys business, policies, procedures, and practices Demonstrated experience in the development, construction, operation and maintenance of large energy infrastructure projects, including familiarity with renewable energy technologies including wind, solar, storage and thermal gas generation Experience in the electric utility industry, resource development, and applicable federal, state and local regulations and permit processes Working knowledge of SAP in cost tracking and forecasting Working knowledge of Primavera scheduling or other project management software Experience in electric utility design and/or construction Preference for the Principal Eng/Ops Project Manager will be given to candidates who have the following: Masters in Business Administration or advanced Engineering or other technical degree Current Professional Engineer License Advanced Project Management or Program Management Certification by the Project Management Institute Understanding of environmental regulations, National Environmental Protection Act, environmental impact statement, environmental assessment, State Historical Preservation Office, Army Corp of Engineers, etc. Knowledge of the Companys business, policies, procedures, and practices Experience in the electric utility industry and applicable federal, state and local regulations. Experience in managing direct reports. Additional Information Req Id: 113556 Company Code: PACIFICORP Primary Location: Portland, Oregon Department: Strategy & Resource Dev Schedule: Full - Time Personnel Subarea: Exempt Hiring Range: 119,400 - 177,300 This position is eligible for an annual discretionary performance incentive bonus of up to 15.00% of salary. Benefits: Health care . click apply for full job details
The Vice President of Government and External Affairs for Education Finance Council (EFC) leads strategic congressional and federal regulatory outreach efforts to advance EFC's advocacy priorities. The role includes managing relationships with the Administration, Congress, and other external stakeholders. The Vice President ensures that EFC's communications to Congress and regulatory agencies are of high-quality and align with EFC's mission and objectives. The Vice President serves as EFC's spokesperson and point of contact for media inquiries; and manages EFC's online presence. This position reports directly to the President. RESPONSIBILITIES Government Affairs In coordination with the President and Government Affairs Committee, develop and implement EFC's government affairs strategy, drafting and advancing policy priorities aligned to EFC's Strategic Plan Monitor and analyze key legislative, judicial, regulatory, and political developments and trends affecting EFC's key issue areas, identifying opportunities for engagement and collaboration with key stakeholders. In coordination with the President, work with key stakeholders to identify policy opportunities and develop, refine, and advance EFC's policy priorities. In coordination with the President, lead EFC's outreach to Capitol Hill, the White House, and federal agencies to ensure the continuation of strong bipartisan relations with them. Provide input and feedback to Congressional members and staff, respond to requests for assistance, provide talking points, testimony, advocacy materials, and other guidance as needed. In coordination with the President, lead and oversee the development and execution of efforts to mobilize EFC Members on key issues and coordinate activities with allied organizations on legislative and policy initiatives External Relationships Build and deepen existing relationships and build new relationships with coalition partners and coordinate efforts with industry based coalitions and outreach to potential allies on issues of mutual interest. Identify opportunities for engagement and collaboration with higher education stakeholders to grow coalitional support for policies important to EFC members. Develop strong working relationships with the U.S. Department of Education and other regulatory agencies and open clear lines of communication with key agency personnel. Manage media relations (write and distribute press releases and pitches, respond to media inquiries, develop and maintain relationships with key reporters, track media coverage of EFC-related issues, write and submit op-eds and letters to the editor). Collaborate with EFC leadership to develop external communications strategies and campaigns to elevate EFC's profile and promote its members, including through social media and management of the EFC website. In coordination with the President, lead EFC's communications strategy to promote the nonprofit and state-based higher "brand," and position EFC members as trusted higher education experts for policymakers and the public. Member Engagement Manage EFC's Government Affairs Committee working with Committee members in the development and implementation of an integrated government relations and strategic communications effort, reviewing and recommending revisions to EFC's strategy to ensure its alignment with EFC's overall strategic plan, the changing political environment, and member feedback. Draft and solicit member input on model legislation including bill language, amendment language, and report language. Oversee coordination of EFC member fly-ins, briefings, panels, etc. Manage EFC's Alternative Education Loan and State Regulations Working Group, exploring ways to address the growing number of state regulations and/or licensing/certification requirements for the origination and servicing of state-based, nonprofit private education loans and foster open discussion for members to share ideas, updates, and network. • Build relationships with EFC members by supporting their requests and needs for data and information. Management Duties and Training For the areas of responsibility outlined in this job description, supervise the Associate Director of Government Affairs and Communications in the completion of assigned tasks; provide training and constructive feedback; and provide input to the President on staff performance for purposes of performance evaluations Additional Responsibilities This job description is not a comprehensive list of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned as determined by the President. ATTRIBUTES AND COMPETENCIES BA/BS required; master's degree preferred Minimum of seven years of relevant experience monitoring and analyzing federal and state legislative and regulatory initiatives Exceptional written and verbal communications skills • Ability to communicate complex ideas in a clear, concise message Ability to build and maintain partnerships and collaborative efforts and to diplomatically manage groups and coalitions Message development skills Some experience with media relations Strong analytical and problem-solving skills, especially in the context of policy initiatives Proficient in project management and interpersonal skills to manage stakeholder relationships effectively Ability to work collaboratively as part of a small team Excellent time management and organizational skills EFC CULTURE EFC is a mission-driven organization that supports its members to expand access to postsecondary education and training, facilitate student success, assist students and families in identifying their best sources of education funding, assist individuals with connecting postsecondary education and career outcomes, encourage responsible borrowing, and advocate for and with individuals in support of successful management of their postsecondary education financing. EFC strives to attract and retain a diverse and talented team. EFC is an equal opportunity employer and does not discriminate with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. CLASSIFICATION AND JOB TYPE Salaried / Exempt, Full-Time COMPENSATION AND BENEFITS Annual Salary Range: $125,000 to $135,000 Generous benefits package, including a retirement savings program with employer contributions, health, dental and vision, long term disability and life insurance. EFC is committed to fostering a culture of learning, team collaboration, and trust. TRAVEL Requires some travel to EFC meetings and conferences, special events and programs, and member site visits JOB LOCATION Greater Washington, DC. EFC provides a flexible, hybrid work schedule working from the DC office at least one day per week, dependent upon DC-based meetings and events, work travel schedule, and organizational needs to support special events and programs. Application Instructions: Please submit a resume and cover letter expressing your interest to with the subject line "Vice President."
04/26/2025
Full time
The Vice President of Government and External Affairs for Education Finance Council (EFC) leads strategic congressional and federal regulatory outreach efforts to advance EFC's advocacy priorities. The role includes managing relationships with the Administration, Congress, and other external stakeholders. The Vice President ensures that EFC's communications to Congress and regulatory agencies are of high-quality and align with EFC's mission and objectives. The Vice President serves as EFC's spokesperson and point of contact for media inquiries; and manages EFC's online presence. This position reports directly to the President. RESPONSIBILITIES Government Affairs In coordination with the President and Government Affairs Committee, develop and implement EFC's government affairs strategy, drafting and advancing policy priorities aligned to EFC's Strategic Plan Monitor and analyze key legislative, judicial, regulatory, and political developments and trends affecting EFC's key issue areas, identifying opportunities for engagement and collaboration with key stakeholders. In coordination with the President, work with key stakeholders to identify policy opportunities and develop, refine, and advance EFC's policy priorities. In coordination with the President, lead EFC's outreach to Capitol Hill, the White House, and federal agencies to ensure the continuation of strong bipartisan relations with them. Provide input and feedback to Congressional members and staff, respond to requests for assistance, provide talking points, testimony, advocacy materials, and other guidance as needed. In coordination with the President, lead and oversee the development and execution of efforts to mobilize EFC Members on key issues and coordinate activities with allied organizations on legislative and policy initiatives External Relationships Build and deepen existing relationships and build new relationships with coalition partners and coordinate efforts with industry based coalitions and outreach to potential allies on issues of mutual interest. Identify opportunities for engagement and collaboration with higher education stakeholders to grow coalitional support for policies important to EFC members. Develop strong working relationships with the U.S. Department of Education and other regulatory agencies and open clear lines of communication with key agency personnel. Manage media relations (write and distribute press releases and pitches, respond to media inquiries, develop and maintain relationships with key reporters, track media coverage of EFC-related issues, write and submit op-eds and letters to the editor). Collaborate with EFC leadership to develop external communications strategies and campaigns to elevate EFC's profile and promote its members, including through social media and management of the EFC website. In coordination with the President, lead EFC's communications strategy to promote the nonprofit and state-based higher "brand," and position EFC members as trusted higher education experts for policymakers and the public. Member Engagement Manage EFC's Government Affairs Committee working with Committee members in the development and implementation of an integrated government relations and strategic communications effort, reviewing and recommending revisions to EFC's strategy to ensure its alignment with EFC's overall strategic plan, the changing political environment, and member feedback. Draft and solicit member input on model legislation including bill language, amendment language, and report language. Oversee coordination of EFC member fly-ins, briefings, panels, etc. Manage EFC's Alternative Education Loan and State Regulations Working Group, exploring ways to address the growing number of state regulations and/or licensing/certification requirements for the origination and servicing of state-based, nonprofit private education loans and foster open discussion for members to share ideas, updates, and network. • Build relationships with EFC members by supporting their requests and needs for data and information. Management Duties and Training For the areas of responsibility outlined in this job description, supervise the Associate Director of Government Affairs and Communications in the completion of assigned tasks; provide training and constructive feedback; and provide input to the President on staff performance for purposes of performance evaluations Additional Responsibilities This job description is not a comprehensive list of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned as determined by the President. ATTRIBUTES AND COMPETENCIES BA/BS required; master's degree preferred Minimum of seven years of relevant experience monitoring and analyzing federal and state legislative and regulatory initiatives Exceptional written and verbal communications skills • Ability to communicate complex ideas in a clear, concise message Ability to build and maintain partnerships and collaborative efforts and to diplomatically manage groups and coalitions Message development skills Some experience with media relations Strong analytical and problem-solving skills, especially in the context of policy initiatives Proficient in project management and interpersonal skills to manage stakeholder relationships effectively Ability to work collaboratively as part of a small team Excellent time management and organizational skills EFC CULTURE EFC is a mission-driven organization that supports its members to expand access to postsecondary education and training, facilitate student success, assist students and families in identifying their best sources of education funding, assist individuals with connecting postsecondary education and career outcomes, encourage responsible borrowing, and advocate for and with individuals in support of successful management of their postsecondary education financing. EFC strives to attract and retain a diverse and talented team. EFC is an equal opportunity employer and does not discriminate with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. CLASSIFICATION AND JOB TYPE Salaried / Exempt, Full-Time COMPENSATION AND BENEFITS Annual Salary Range: $125,000 to $135,000 Generous benefits package, including a retirement savings program with employer contributions, health, dental and vision, long term disability and life insurance. EFC is committed to fostering a culture of learning, team collaboration, and trust. TRAVEL Requires some travel to EFC meetings and conferences, special events and programs, and member site visits JOB LOCATION Greater Washington, DC. EFC provides a flexible, hybrid work schedule working from the DC office at least one day per week, dependent upon DC-based meetings and events, work travel schedule, and organizational needs to support special events and programs. Application Instructions: Please submit a resume and cover letter expressing your interest to with the subject line "Vice President."
Job Description: The Chicago School is a not-for-profit, WSCUC-accredited institution with over 6000 students at campuses across the country (Chicago, Southern California, Dallas, and Washington, D.C.) and online. As the nation's oldest and largest independent professional school devoted to psychology and related behavioral health sciences, TCSPP offers more than 30 degree programs and a wealth of opportunities through community partnerships. Our curriculum and training opportunities prepare graduates to deliver outstanding professional services emphasizing the ability to understand and work with diverse populations. Position Summary The Director of Educational Effectiveness is a national position working in the Office of Academic Affairs. The position is a full-time staff position. Under the direction of the AVP of Academic Affairs, this position is responsible for working with the faculty National Academic Standards & Effectiveness Review Committee to manage the Academic Program Review process. Through this quality assurance process programs are reviewed, systematically updated, evaluated, and revised. This person will also provide consultation around best methods in assessment and developing curriculum maps for new and existing programs. This position interacts with college, staff, and program leadership on a regular basis. Duties and Responsibilities • Act as staff liaison to the National Academic Standards & Effectiveness Review Committee (NASERC) representing Academic Affairs • Manage the Academic Program Review Process Act as Program Review Liaison to academic units within The Chicago School Update and revise the Program Review Documents policies, procedures and program review templates/forms in collaboration with NASERC. Coordinate the programmatic self-study process. Advise and support the programs conducting Self-Studies. Manage Self-Study quality circles Work with program chairs to develop and monitor implementation of their program's strategic plan and action plans. Develop and conduct webinars on annual programmatic review updates and best practices in other areas of assessment of student learning and program review in collaboration with The National Center for Teaching and Learning and The Community Solution. Coordinate the programmatic annual update process. o Annually provide a report to the Institutional Effectiveness Review Committee on the cross-program findings of the academic program review process. Maintain record copies of curriculum structure documents (Curriculum Maps, Assessment Plans, Program Learning Outcomes and Rubrics). Act as a Data Coach to facilitate use of data provided by the Office of Institutional Research to inform decision-making. Prepare and maintain The Chicago School Program Review Repository and the Academic Review Calendar. Participate as an ex-officio member of the Institutional Effectiveness Review Committee (IERC) Participate in the Co-curricular Operational Excellence Review Process as a member of the Office of Program Development. Support The National Center for Teaching and Learning by participating in the New Adjunct Faculty Orientation every semester. • Support New Program Development Collaborate with and support the Director of the Office of Program Development on new program development, respectively; provide support and oversight to the faculty subject matter experts in the development of curriculum structure documentation of new programs to include curriculum maps and assessment plans. • Support the Program Modification Process Collaborate with the Program Development Specialist to support program modifications; support faculty to update curriculum structure documents, to include revision of curriculum maps and assessment plans. • Support Institutional and Programmatic Accreditation Processes Collaborate in the development of the WSCUC accreditation reports and substantive change requests and applications for state regulatory approvals as requested Write/review required reports for programmatic accreditation reviews Represent The Chicago School in matters of assessment during accreditation meetings and site visits. • Professional Development Attend seminars, meetings, and graining pertaining to assessment and accreditation Keep abreast of higher education assessment and accreditation developments, trends and issues. • Other duties as assigned. EDUCATION Doctoral level education in education with a focus on curriculum/instructional design and quality assurance. EXPERIENCE Five years academic leadership Successful track record of working with faculty and department chairs to achieve organizational objectives. Demonstrated achievement of outcomes within non-negotiable timelines Success in writing for an external audience including production of quality communications documents Action research SPECIALIZED KNOWLEDGE, SKILLS, ABILITIES: Exceptional interpersonal skills and ability to develop productive relationships Peer reviewer for institutional accreditation Experience with programmatic accreditation Strong project management skills and ability to organize and track complex projects with multiple constituencies Ability to analyze situations and requests for information in accordance with educational policy. Strong proofreading skills with attention to detail Strong statistical, analytical, and research skills. Technological experience, including Office 365 For more information about The Chicago School please visit . The Chicago School of is an affiliate of The Community Solution Education System. For more information about The Community Solution visit . The Chicago School is committed to providing equal employment opportunity without regard to ethnicity, race, age, gender, pregnancy, religion, sexual orientation, ancestry, national origin, physical disability, mental disability, military status, marital status, or any other characteristic protected by law. TCS believes that the full use of talent can be achieved by adopting practices that will ensure the enrichment of our employment climate with diverse persons/experiences. Such practices not only result in effective operations, but also foster an environment in which community building and our shared mission our perpetuated. The Community Solution Education System offers a generous compensation and benefits package, as well as the opportunity to work for a leader in the field of education. Some of our key benefits include: paid time-off, medical and dental coverage, company-paid life and disability insurance, retirement plan, multiple flexible spending accounts (FSA), professional development, and regular employee appreciation events. The Community Solution Education System is an Equal Opportunity Employer Compensation & BenefitsThis opportunity is budgeted at 95,000 to $112,500 base compensation. Additional compensation factors may impact total compensation. To learn more about our competitive benefits and additional rewards, including generous paid time-off, medical and dental insurance coverage, life and disability insurance, retirement plan with employer contribution, multiple flexible spending accounts, tuition reimbursement, click the link below. The Chicago School is an Equal Opportunity Employer. Please note: For the protection of faculty, staff, students, and all who enter our facilities, The Chicago School strongly recommends that all employees are fully vaccinated for COVID-19 per CDC guidance.
04/25/2025
Full time
Job Description: The Chicago School is a not-for-profit, WSCUC-accredited institution with over 6000 students at campuses across the country (Chicago, Southern California, Dallas, and Washington, D.C.) and online. As the nation's oldest and largest independent professional school devoted to psychology and related behavioral health sciences, TCSPP offers more than 30 degree programs and a wealth of opportunities through community partnerships. Our curriculum and training opportunities prepare graduates to deliver outstanding professional services emphasizing the ability to understand and work with diverse populations. Position Summary The Director of Educational Effectiveness is a national position working in the Office of Academic Affairs. The position is a full-time staff position. Under the direction of the AVP of Academic Affairs, this position is responsible for working with the faculty National Academic Standards & Effectiveness Review Committee to manage the Academic Program Review process. Through this quality assurance process programs are reviewed, systematically updated, evaluated, and revised. This person will also provide consultation around best methods in assessment and developing curriculum maps for new and existing programs. This position interacts with college, staff, and program leadership on a regular basis. Duties and Responsibilities • Act as staff liaison to the National Academic Standards & Effectiveness Review Committee (NASERC) representing Academic Affairs • Manage the Academic Program Review Process Act as Program Review Liaison to academic units within The Chicago School Update and revise the Program Review Documents policies, procedures and program review templates/forms in collaboration with NASERC. Coordinate the programmatic self-study process. Advise and support the programs conducting Self-Studies. Manage Self-Study quality circles Work with program chairs to develop and monitor implementation of their program's strategic plan and action plans. Develop and conduct webinars on annual programmatic review updates and best practices in other areas of assessment of student learning and program review in collaboration with The National Center for Teaching and Learning and The Community Solution. Coordinate the programmatic annual update process. o Annually provide a report to the Institutional Effectiveness Review Committee on the cross-program findings of the academic program review process. Maintain record copies of curriculum structure documents (Curriculum Maps, Assessment Plans, Program Learning Outcomes and Rubrics). Act as a Data Coach to facilitate use of data provided by the Office of Institutional Research to inform decision-making. Prepare and maintain The Chicago School Program Review Repository and the Academic Review Calendar. Participate as an ex-officio member of the Institutional Effectiveness Review Committee (IERC) Participate in the Co-curricular Operational Excellence Review Process as a member of the Office of Program Development. Support The National Center for Teaching and Learning by participating in the New Adjunct Faculty Orientation every semester. • Support New Program Development Collaborate with and support the Director of the Office of Program Development on new program development, respectively; provide support and oversight to the faculty subject matter experts in the development of curriculum structure documentation of new programs to include curriculum maps and assessment plans. • Support the Program Modification Process Collaborate with the Program Development Specialist to support program modifications; support faculty to update curriculum structure documents, to include revision of curriculum maps and assessment plans. • Support Institutional and Programmatic Accreditation Processes Collaborate in the development of the WSCUC accreditation reports and substantive change requests and applications for state regulatory approvals as requested Write/review required reports for programmatic accreditation reviews Represent The Chicago School in matters of assessment during accreditation meetings and site visits. • Professional Development Attend seminars, meetings, and graining pertaining to assessment and accreditation Keep abreast of higher education assessment and accreditation developments, trends and issues. • Other duties as assigned. EDUCATION Doctoral level education in education with a focus on curriculum/instructional design and quality assurance. EXPERIENCE Five years academic leadership Successful track record of working with faculty and department chairs to achieve organizational objectives. Demonstrated achievement of outcomes within non-negotiable timelines Success in writing for an external audience including production of quality communications documents Action research SPECIALIZED KNOWLEDGE, SKILLS, ABILITIES: Exceptional interpersonal skills and ability to develop productive relationships Peer reviewer for institutional accreditation Experience with programmatic accreditation Strong project management skills and ability to organize and track complex projects with multiple constituencies Ability to analyze situations and requests for information in accordance with educational policy. Strong proofreading skills with attention to detail Strong statistical, analytical, and research skills. Technological experience, including Office 365 For more information about The Chicago School please visit . The Chicago School of is an affiliate of The Community Solution Education System. For more information about The Community Solution visit . The Chicago School is committed to providing equal employment opportunity without regard to ethnicity, race, age, gender, pregnancy, religion, sexual orientation, ancestry, national origin, physical disability, mental disability, military status, marital status, or any other characteristic protected by law. TCS believes that the full use of talent can be achieved by adopting practices that will ensure the enrichment of our employment climate with diverse persons/experiences. Such practices not only result in effective operations, but also foster an environment in which community building and our shared mission our perpetuated. The Community Solution Education System offers a generous compensation and benefits package, as well as the opportunity to work for a leader in the field of education. Some of our key benefits include: paid time-off, medical and dental coverage, company-paid life and disability insurance, retirement plan, multiple flexible spending accounts (FSA), professional development, and regular employee appreciation events. The Community Solution Education System is an Equal Opportunity Employer Compensation & BenefitsThis opportunity is budgeted at 95,000 to $112,500 base compensation. Additional compensation factors may impact total compensation. To learn more about our competitive benefits and additional rewards, including generous paid time-off, medical and dental insurance coverage, life and disability insurance, retirement plan with employer contribution, multiple flexible spending accounts, tuition reimbursement, click the link below. The Chicago School is an Equal Opportunity Employer. Please note: For the protection of faculty, staff, students, and all who enter our facilities, The Chicago School strongly recommends that all employees are fully vaccinated for COVID-19 per CDC guidance.
Job Title: Director, Global Market Access and Government Affairs Location: Remote w/travel Comp: 200-230K depending on experience Leading Medical Device Company is hiring a Director - Patient Access and Government Affairs w/ 6+ years industry experience. If you want to be a part of this groundbreaking work, please apply! Must haves: Advanced degree in Public Health, Health Economics, Public Policy, or a related field or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Over 12 years of leadership experience in the medical device industry (or, less preferably, pharma) with a focus on market access, government affairs, or public policy. Market access and govt affairs experience at a global level (EMEA, North America, APAC, China, and LATAM) US govt affairs team is the skinniest Substantial knowledge of EU and/or US governmental and reimbursement processes. Knowledge concerning other regions e.g. China, Brazil, India, SSA, Japan is an asset. Experience with Health Economics models and clinical-economic dossier development. Knowledge of blood, plasma, or cell therapy is a significant advantage. Direct, align and ensue commitments/align people and internal budgets/ensure commitments from within team and within other stakeholders internally French, German, Chinese, Spanish bilingual is a plus Relationships with MedTech Europe, Advamed, APAC medical, connections on the hill, European commission and parliament are great. What will be the top day to day responsibilities of this individual? Overseeing government affairs and market access leaders across EMEA, North America, APAC, China, and LATAM. Reporting to the Vice President of Patient Access, this position is integral to the Patient Access Leadership Team, which comprises Medical Affairs, Government Affairs, and Market Access. Develop and execute strategies that drive patient access and enhance global impact. Lead a diverse global team, fostering collaboration across regions. Develop and implement integrated market access and reimbursement strategies to support product launches and lifecycle management. Build partnerships with major payers, public institutions, and other stakeholders to support innovative therapies. Influence healthcare policies and trends, ensuring long-term success in the healthcare ecosystem. Shape and influence public policy to create favorable environments for market access. Engage with government officials, policymakers, and regulatory agencies to advocate for policies supporting patient access. Monitor and analyze legislative and regulatory developments to identify opportunities and risks. Interpret key developments in government health, economic, trade, science and innovation policy, identify the opportunities and threats to our business and develop appropriate plans to influence and engage in policy development in line with strategic and commercial objectives. Identify opportunities from a health policy, healthcare funding or governmental initiatives perspective that may be beneficial and guide senior leadership on how to engage in these initiatives. Oversee budget planning, annual planning Ensure compliance with relevant laws, regulations, and company policies. Utilize data-driven insights to inform strategies and decisions. Internal knowledge building: grow internal knowledge related to government affairs, market access and public policy by organizing internal education sessions. Communication: develop and maintain clear, concise, and compelling communication materials to support government affairs and market access initiatives. This includes position papers, briefing documents, and public relations efforts. Lead negotiations with local authorities to secure optimal access and pricing. Provide access and policy insights during strategic planning. Adapt global value dossiers and Health Economics models, leveraging local data for effective submissions. Ensure timely and effective submission of reimbursement requests. Collaborate with industry associations, think tanks, and advocacy groups to promote policies benefiting patient access. Educate policymakers about the role of blood components as essential medicines. Ref: Required Preferred Job Industries Healthcare
04/25/2025
Full time
Job Title: Director, Global Market Access and Government Affairs Location: Remote w/travel Comp: 200-230K depending on experience Leading Medical Device Company is hiring a Director - Patient Access and Government Affairs w/ 6+ years industry experience. If you want to be a part of this groundbreaking work, please apply! Must haves: Advanced degree in Public Health, Health Economics, Public Policy, or a related field or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Over 12 years of leadership experience in the medical device industry (or, less preferably, pharma) with a focus on market access, government affairs, or public policy. Market access and govt affairs experience at a global level (EMEA, North America, APAC, China, and LATAM) US govt affairs team is the skinniest Substantial knowledge of EU and/or US governmental and reimbursement processes. Knowledge concerning other regions e.g. China, Brazil, India, SSA, Japan is an asset. Experience with Health Economics models and clinical-economic dossier development. Knowledge of blood, plasma, or cell therapy is a significant advantage. Direct, align and ensue commitments/align people and internal budgets/ensure commitments from within team and within other stakeholders internally French, German, Chinese, Spanish bilingual is a plus Relationships with MedTech Europe, Advamed, APAC medical, connections on the hill, European commission and parliament are great. What will be the top day to day responsibilities of this individual? Overseeing government affairs and market access leaders across EMEA, North America, APAC, China, and LATAM. Reporting to the Vice President of Patient Access, this position is integral to the Patient Access Leadership Team, which comprises Medical Affairs, Government Affairs, and Market Access. Develop and execute strategies that drive patient access and enhance global impact. Lead a diverse global team, fostering collaboration across regions. Develop and implement integrated market access and reimbursement strategies to support product launches and lifecycle management. Build partnerships with major payers, public institutions, and other stakeholders to support innovative therapies. Influence healthcare policies and trends, ensuring long-term success in the healthcare ecosystem. Shape and influence public policy to create favorable environments for market access. Engage with government officials, policymakers, and regulatory agencies to advocate for policies supporting patient access. Monitor and analyze legislative and regulatory developments to identify opportunities and risks. Interpret key developments in government health, economic, trade, science and innovation policy, identify the opportunities and threats to our business and develop appropriate plans to influence and engage in policy development in line with strategic and commercial objectives. Identify opportunities from a health policy, healthcare funding or governmental initiatives perspective that may be beneficial and guide senior leadership on how to engage in these initiatives. Oversee budget planning, annual planning Ensure compliance with relevant laws, regulations, and company policies. Utilize data-driven insights to inform strategies and decisions. Internal knowledge building: grow internal knowledge related to government affairs, market access and public policy by organizing internal education sessions. Communication: develop and maintain clear, concise, and compelling communication materials to support government affairs and market access initiatives. This includes position papers, briefing documents, and public relations efforts. Lead negotiations with local authorities to secure optimal access and pricing. Provide access and policy insights during strategic planning. Adapt global value dossiers and Health Economics models, leveraging local data for effective submissions. Ensure timely and effective submission of reimbursement requests. Collaborate with industry associations, think tanks, and advocacy groups to promote policies benefiting patient access. Educate policymakers about the role of blood components as essential medicines. Ref: Required Preferred Job Industries Healthcare
Company Description Augsburg University has maintained a strong academic reputation defined by excellence in the liberal arts and professional studies since 1869. A safe and welcoming campus in the heart of Minneapolis, Augsburg offers undergraduate and graduate degrees to nearly 3,200 diverse students. Augsburg's mission is to educate students to be informed citizens, thoughtful stewards, critical thinkers, and responsible leaders. The Augsburg experience is supported by an engaged community that is committed to intentional diversity in its life and work. An Augsburg education is defined by excellence in the liberal arts and professional studies, guided by the faith and values of the Lutheran church, and shaped by its urban and global settings. Augsburg invites individuals who share our mission and commitment to intentional diversity, equity, inclusion and belonging to join our community. In particular, Augsburg invites BIPOC, LGBTQIA+, individuals with disabilities, women, veterans and those from underrepresented or marginalized backgrounds are encouraged to apply. Summary of Position The Director of Academic Administration is responsible for the success of operational processes that support the work of the Provost's leadership team and other stakeholders in leading the University's academic programs. Analyzes and strengthens systems to enhance continuous improvement, and ensure evidence-based decision-making. This position works collaboratively with multiple offices across the University to ensure smooth operations of the University's academic programs. Primary Responsibilities Serve as the senior advisor to the Provost and Senior Vice President of Academic and Student Affairs on issues related to teaching and learning, compliance, budgets, space allocation, planning and resources, and talent acquisition. Prepare and monitor all operating and compensation budgets under the Provost ( $20MM); advise on resource allocations and expenditures in collaboration with the CFO. Lead, define, and improve institutional operations and academic analytics in close collaboration with senior leaders within the Provost's office. Serve as the liaison to the MN Office of Higher Education (MOHE) and the National Council for State Authorization Reciprocity Agreements (NC-SARA); prepare and submit annual renewals and program updates. Oversee tracking, reporting, and documenting of faculty workloads Conduct faculty compensation studies and negotiate faculty employment offers. Manage annual faculty appointments and coordinate appointment letters of renewal and non-renewal. Partner with Human Resources and Payroll to ensure accurate data is provided regarding faculty workloads, appointments, and compensation. Ensure compliance with federal and state laws and regulations; serve as the liaison to regulatory authorities in concert with the Office of Planning and Effectiveness and Human Resources. Coordinate course enrollment management with School Directors, Associate Provost, and Associate Dean for Student Success. Supervise administrative staff. Review and submit information for annual surveys and reports. Serve as the Provost's representative, providing administrative support to faculty and leadership committees as assigned. Additional Responsibilities Lead, foster, and support evidence-based decision-making for Academic and Student Affairs leadership through systems that ensure data integrity, robust reporting, and analysis. Manage oversight of faculty's outside employment and leaves, as needed. Serve as Provost's Office liaison to the SEIU adjunct union. Serve as liaison to the Office of Grants and Sponsored Programs. All other duties as apparent or as assigned by supervisor(s). Work Environment and Physical Demands Typical work environment is an office. Regular computer and phone use. Minimum Qualifications Master's degree. Seven (7) years of professional experience in higher education administration, a leadership role at a college/university, or a related field. Minimum of two (2) years of experience supervising professional staff. Experience with enterprise information systems and data reporting tools. Preferred Qualifications Doctoral degree. Knowledge, Skills, Abilities Strong analytical skills Excellent verbal and written communication skills and the ability to communicate effectively to diverse audiences. Must demonstrate strong attention to detail and accuracy. Ability to work effectively in a team environment and independently with little supervision. Ability to maintain confidentiality. Ability to show initiative and organize multiple time-sensitive priorities. Application Requirements Please submit a resume and cover letter to be considered for this position. The position will remain open until filled, but for first consideration please submit your application and materials by Wednesday, April 2, 2025. Compensation and Benefits at Augsburg The compensation range is $85,000 - $100,000 per year, DOQ. Augsburg University offers a competitive and comprehensive total rewards program including: Medical, dental and vision coverage A generous 403(b) matching program with an employer contributions of up to 8% upon eligibility Up to 100% tuition remission for employees, spouses and dependents, and participation in the Tuition Exchange program with colleges and universities throughout the US Generous paid time-off, including 14 paid holidays, 12 sick days, 2 community service days, and vacation of up to 22 days per year immediately upon hire Employer-paid STD, LTD and life insurance Employee Assistance Program (EAP) for all employees Equal Opportunity and Affirmative Action Statement Augsburg is an equal opportunity employer and does not discriminate on the basis of gender, sexual orientation, marital status, gender identity, race, age, disability, religion, national origin, color, or any other protected class. Augsburg University is committed to providing equal employment opportunity to all applicants and employees regardless of their race, color, creed, religion, gender, age, national origin, familial status, disability, veteran status, sexual orientation, gender identity, gender expression, marital status or public assistance status, or any other characteristic protected by federal, state, or local law. If you need a reasonable accommodation to complete our application process, please contact our Human Resources Department at phone number: or email: .
04/25/2025
Full time
Company Description Augsburg University has maintained a strong academic reputation defined by excellence in the liberal arts and professional studies since 1869. A safe and welcoming campus in the heart of Minneapolis, Augsburg offers undergraduate and graduate degrees to nearly 3,200 diverse students. Augsburg's mission is to educate students to be informed citizens, thoughtful stewards, critical thinkers, and responsible leaders. The Augsburg experience is supported by an engaged community that is committed to intentional diversity in its life and work. An Augsburg education is defined by excellence in the liberal arts and professional studies, guided by the faith and values of the Lutheran church, and shaped by its urban and global settings. Augsburg invites individuals who share our mission and commitment to intentional diversity, equity, inclusion and belonging to join our community. In particular, Augsburg invites BIPOC, LGBTQIA+, individuals with disabilities, women, veterans and those from underrepresented or marginalized backgrounds are encouraged to apply. Summary of Position The Director of Academic Administration is responsible for the success of operational processes that support the work of the Provost's leadership team and other stakeholders in leading the University's academic programs. Analyzes and strengthens systems to enhance continuous improvement, and ensure evidence-based decision-making. This position works collaboratively with multiple offices across the University to ensure smooth operations of the University's academic programs. Primary Responsibilities Serve as the senior advisor to the Provost and Senior Vice President of Academic and Student Affairs on issues related to teaching and learning, compliance, budgets, space allocation, planning and resources, and talent acquisition. Prepare and monitor all operating and compensation budgets under the Provost ( $20MM); advise on resource allocations and expenditures in collaboration with the CFO. Lead, define, and improve institutional operations and academic analytics in close collaboration with senior leaders within the Provost's office. Serve as the liaison to the MN Office of Higher Education (MOHE) and the National Council for State Authorization Reciprocity Agreements (NC-SARA); prepare and submit annual renewals and program updates. Oversee tracking, reporting, and documenting of faculty workloads Conduct faculty compensation studies and negotiate faculty employment offers. Manage annual faculty appointments and coordinate appointment letters of renewal and non-renewal. Partner with Human Resources and Payroll to ensure accurate data is provided regarding faculty workloads, appointments, and compensation. Ensure compliance with federal and state laws and regulations; serve as the liaison to regulatory authorities in concert with the Office of Planning and Effectiveness and Human Resources. Coordinate course enrollment management with School Directors, Associate Provost, and Associate Dean for Student Success. Supervise administrative staff. Review and submit information for annual surveys and reports. Serve as the Provost's representative, providing administrative support to faculty and leadership committees as assigned. Additional Responsibilities Lead, foster, and support evidence-based decision-making for Academic and Student Affairs leadership through systems that ensure data integrity, robust reporting, and analysis. Manage oversight of faculty's outside employment and leaves, as needed. Serve as Provost's Office liaison to the SEIU adjunct union. Serve as liaison to the Office of Grants and Sponsored Programs. All other duties as apparent or as assigned by supervisor(s). Work Environment and Physical Demands Typical work environment is an office. Regular computer and phone use. Minimum Qualifications Master's degree. Seven (7) years of professional experience in higher education administration, a leadership role at a college/university, or a related field. Minimum of two (2) years of experience supervising professional staff. Experience with enterprise information systems and data reporting tools. Preferred Qualifications Doctoral degree. Knowledge, Skills, Abilities Strong analytical skills Excellent verbal and written communication skills and the ability to communicate effectively to diverse audiences. Must demonstrate strong attention to detail and accuracy. Ability to work effectively in a team environment and independently with little supervision. Ability to maintain confidentiality. Ability to show initiative and organize multiple time-sensitive priorities. Application Requirements Please submit a resume and cover letter to be considered for this position. The position will remain open until filled, but for first consideration please submit your application and materials by Wednesday, April 2, 2025. Compensation and Benefits at Augsburg The compensation range is $85,000 - $100,000 per year, DOQ. Augsburg University offers a competitive and comprehensive total rewards program including: Medical, dental and vision coverage A generous 403(b) matching program with an employer contributions of up to 8% upon eligibility Up to 100% tuition remission for employees, spouses and dependents, and participation in the Tuition Exchange program with colleges and universities throughout the US Generous paid time-off, including 14 paid holidays, 12 sick days, 2 community service days, and vacation of up to 22 days per year immediately upon hire Employer-paid STD, LTD and life insurance Employee Assistance Program (EAP) for all employees Equal Opportunity and Affirmative Action Statement Augsburg is an equal opportunity employer and does not discriminate on the basis of gender, sexual orientation, marital status, gender identity, race, age, disability, religion, national origin, color, or any other protected class. Augsburg University is committed to providing equal employment opportunity to all applicants and employees regardless of their race, color, creed, religion, gender, age, national origin, familial status, disability, veteran status, sexual orientation, gender identity, gender expression, marital status or public assistance status, or any other characteristic protected by federal, state, or local law. If you need a reasonable accommodation to complete our application process, please contact our Human Resources Department at phone number: or email: .
Director of Federal Affairs Division : President Department : 1G1000 Government Relations Role Code/Title : 01221 Professional/Lecturer (Staff) Position Number : FPA74W Position Title : Director of Federal Affairs ECLS and FSLA: 01-Exec/Prof 12-Month FT U-range: U20 Recommended Hiring Range: $150,000-$180,000 commensurate with experience Base Budget Amount: $155,000 Position Reports To: FP497W Ashley Hood - Assistant Vice President of Government & External Affairs U21 Position Summary: The W&M Office of Government & External Affairs is seeking a Director of Federal Affairs to represent W&M and VIMS in Washington, D.C. Reporting to the Assistant Vice President for Government & External Affairs, the Director of Federal Affairs leads W&M's engagement with federal government officials and agencies on policy, legislative, and budgetary matters relevant to academic and research interests. This role develops and implements the University's strategic agenda with the federal government. The Director enhances the visibility and influence of W&M and VIMS with federal decision-makers to advance the University's mission. The position is based in Washington, D.C. and requires travel to W&M's main campus in Williamsburg, VA and the Virginia Institute of Marine Science (VIMS) in Gloucester Point, VA. Responsibilities include: Develop and implement a comprehensive strategic plan, priorities, and advocacy strategy for federal relations. Develop effective relationships with Members of Congress, key Congressional staff, leadership and members of the Committees of jurisdiction in the House and Senate, representatives of the Administration, and federal agencies. Coordinate W&M and VIMS requests and outreach to federal policymakers, particularly within the Virginia congressional delegation. Monitor federal legislation, rules, and regulations impacting W&M and VIMS, develop institutional responses and assist in University-approved legislative initiatives and appropriations requests. Assist faculty, staff, and the Vice Provost for Research in identifying and pursuing federal research funding opportunities. Provide strategic guidance, training, and support to senior leaders, faculty, and staff for interactions with decision-makers. Prepare reports on federal legislative and regulatory activity for leadership and for government compliance. Assist in building and maintaining relationships with W&M alumni in Washington, D.C. Represent W&M and VIMS nationally as part of our participation with associations such as APLU, ACE, AASCU, CASE, with other Virginia public institutions via the Alliance, and with other relevant organizations. Identify opportunities to advance W&M's and VIMS' missions, such as speaking engagements, sponsored events, industry partnerships, and shared advocacy initiatives. Manage and coordinate with external lobbying firm(s) on all of the above. Other projects and duties as assigned by the AVP for Government & External Affairs, Chief of Staff, and President. Required Qualifications: Master's degree or equivalent combination of education, experience, and training. Comprehensive experience working on Capitol Hill, conducting federal government relations, or a combination thereof, with a record of effectiveness in advancing objectives. Five years of relevant experience required; ten years preferred; and not subject to any kind of lobbying ban. Considerable knowledge of legislative process and demonstrated ability to identify legislative issues of relevance and/or concern, solve problems, and successfully propagate the University's legislative agenda. Considerable knowledge of political and governmental protocol. Considerable knowledge of Congressional and federal policies and legislative/rulemaking processes. Proven record of dealing with confidential information. Excellent verbal and written communication; ability to deliver a clear and compelling message. Demonstrated ability to work proactively and independently. Demonstrated ability to actively engaged in divers and equitable thought and promote such a work environment. Preferred Qualifications: Substantive first-hand knowledge of Congressional and federal policies and legislative and rulemaking processes. Established connections and experience with research-related funding. Established bipartisan relationships. Considerable experience and exposure working in education policy. Conditions of Employment: This position will be based in our Washington Center office. Occasional travel to/from the Williamsburg, VA and Gloucester Point, VA campuses will be necessary. This position may require work outside of the normal business hours to meet the needs of the office. Duties: 75% - Federal Relations: Develop and implement a comprehensive strategic plan, priorities, and advocacy strategy for federal relations. Develop effective relationships with Members of Congress, key Congressional staff, leadership and members of the Committees of jurisdiction in the House and Senate, representatives of the Administration, and federal agencies. Coordinate W&M and VIMS requests and outreach to federal policymakers, particularly within the Virginia congressional delegation. Monitor federal legislation, rules, and regulations impacting W&M and VIMS, develop institutional responses and assist in University-approved legislative initiatives and appropriations requests. Assist faculty, staff, and the Vice Provost for Research in identifying and pursuing federal research funding opportunities. Provide strategic guidance, training, and support to senior leaders, faculty, and staff for interactions with decision-makers. Assist in building and maintaining relationships with W&M alumni in Washington, D.C. Represent W&M and VIMS nationally as part of our participation with associations such as APLU, ACE, AASCU, CASE, with other Virginia public institutions via the Alliance, and with other relevant organizations. Identify opportunities to advance W&M's and VIMS' missions, such as speaking engagements, sponsored events, industry partnerships, and shared advocacy initiatives. Manage and coordinate with external lobbying firm(s) on all the above. 25% - Compliance and Other Projects: Ensures institution's compliance with all related lobbying disclosure and ethics rules. Prepare reports on federal legislative and regulatory activity for leadership and for government compliance. Other projects and duties as assigned by the AVP for Government & External Affairs, Chief of Staff, and President. Learn more and apply EEO Statement: William & Mary values diversity and invites applications from underrepresented groups who will enrich the research, teaching and service missions of the university. The university is an Equal Opportunity/Affirmative Action employer and encourages applications from women, minorities, protected veterans, and individuals with disabilities.
04/25/2025
Full time
Director of Federal Affairs Division : President Department : 1G1000 Government Relations Role Code/Title : 01221 Professional/Lecturer (Staff) Position Number : FPA74W Position Title : Director of Federal Affairs ECLS and FSLA: 01-Exec/Prof 12-Month FT U-range: U20 Recommended Hiring Range: $150,000-$180,000 commensurate with experience Base Budget Amount: $155,000 Position Reports To: FP497W Ashley Hood - Assistant Vice President of Government & External Affairs U21 Position Summary: The W&M Office of Government & External Affairs is seeking a Director of Federal Affairs to represent W&M and VIMS in Washington, D.C. Reporting to the Assistant Vice President for Government & External Affairs, the Director of Federal Affairs leads W&M's engagement with federal government officials and agencies on policy, legislative, and budgetary matters relevant to academic and research interests. This role develops and implements the University's strategic agenda with the federal government. The Director enhances the visibility and influence of W&M and VIMS with federal decision-makers to advance the University's mission. The position is based in Washington, D.C. and requires travel to W&M's main campus in Williamsburg, VA and the Virginia Institute of Marine Science (VIMS) in Gloucester Point, VA. Responsibilities include: Develop and implement a comprehensive strategic plan, priorities, and advocacy strategy for federal relations. Develop effective relationships with Members of Congress, key Congressional staff, leadership and members of the Committees of jurisdiction in the House and Senate, representatives of the Administration, and federal agencies. Coordinate W&M and VIMS requests and outreach to federal policymakers, particularly within the Virginia congressional delegation. Monitor federal legislation, rules, and regulations impacting W&M and VIMS, develop institutional responses and assist in University-approved legislative initiatives and appropriations requests. Assist faculty, staff, and the Vice Provost for Research in identifying and pursuing federal research funding opportunities. Provide strategic guidance, training, and support to senior leaders, faculty, and staff for interactions with decision-makers. Prepare reports on federal legislative and regulatory activity for leadership and for government compliance. Assist in building and maintaining relationships with W&M alumni in Washington, D.C. Represent W&M and VIMS nationally as part of our participation with associations such as APLU, ACE, AASCU, CASE, with other Virginia public institutions via the Alliance, and with other relevant organizations. Identify opportunities to advance W&M's and VIMS' missions, such as speaking engagements, sponsored events, industry partnerships, and shared advocacy initiatives. Manage and coordinate with external lobbying firm(s) on all of the above. Other projects and duties as assigned by the AVP for Government & External Affairs, Chief of Staff, and President. Required Qualifications: Master's degree or equivalent combination of education, experience, and training. Comprehensive experience working on Capitol Hill, conducting federal government relations, or a combination thereof, with a record of effectiveness in advancing objectives. Five years of relevant experience required; ten years preferred; and not subject to any kind of lobbying ban. Considerable knowledge of legislative process and demonstrated ability to identify legislative issues of relevance and/or concern, solve problems, and successfully propagate the University's legislative agenda. Considerable knowledge of political and governmental protocol. Considerable knowledge of Congressional and federal policies and legislative/rulemaking processes. Proven record of dealing with confidential information. Excellent verbal and written communication; ability to deliver a clear and compelling message. Demonstrated ability to work proactively and independently. Demonstrated ability to actively engaged in divers and equitable thought and promote such a work environment. Preferred Qualifications: Substantive first-hand knowledge of Congressional and federal policies and legislative and rulemaking processes. Established connections and experience with research-related funding. Established bipartisan relationships. Considerable experience and exposure working in education policy. Conditions of Employment: This position will be based in our Washington Center office. Occasional travel to/from the Williamsburg, VA and Gloucester Point, VA campuses will be necessary. This position may require work outside of the normal business hours to meet the needs of the office. Duties: 75% - Federal Relations: Develop and implement a comprehensive strategic plan, priorities, and advocacy strategy for federal relations. Develop effective relationships with Members of Congress, key Congressional staff, leadership and members of the Committees of jurisdiction in the House and Senate, representatives of the Administration, and federal agencies. Coordinate W&M and VIMS requests and outreach to federal policymakers, particularly within the Virginia congressional delegation. Monitor federal legislation, rules, and regulations impacting W&M and VIMS, develop institutional responses and assist in University-approved legislative initiatives and appropriations requests. Assist faculty, staff, and the Vice Provost for Research in identifying and pursuing federal research funding opportunities. Provide strategic guidance, training, and support to senior leaders, faculty, and staff for interactions with decision-makers. Assist in building and maintaining relationships with W&M alumni in Washington, D.C. Represent W&M and VIMS nationally as part of our participation with associations such as APLU, ACE, AASCU, CASE, with other Virginia public institutions via the Alliance, and with other relevant organizations. Identify opportunities to advance W&M's and VIMS' missions, such as speaking engagements, sponsored events, industry partnerships, and shared advocacy initiatives. Manage and coordinate with external lobbying firm(s) on all the above. 25% - Compliance and Other Projects: Ensures institution's compliance with all related lobbying disclosure and ethics rules. Prepare reports on federal legislative and regulatory activity for leadership and for government compliance. Other projects and duties as assigned by the AVP for Government & External Affairs, Chief of Staff, and President. Learn more and apply EEO Statement: William & Mary values diversity and invites applications from underrepresented groups who will enrich the research, teaching and service missions of the university. The university is an Equal Opportunity/Affirmative Action employer and encourages applications from women, minorities, protected veterans, and individuals with disabilities.
University of California Agriculture and Natural Resources
Davis, California
UC Cooperative Extension - Director of County Cooperative Extention - Academic Administrator or Academic Coordinator III Series (25-09) University of California Agriculture and Natural Resources Application Window Open date: April 14, 2025 Next review date: Wednesday, May 21, 2025 at 11:59pm (Pacific Time) Apply by this date to ensure full consideration by the committee. Final date: Friday, Jun 20, 2025 at 11:59pm (Pacific Time) Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled. Position description Position Overview The University of California, Agriculture and Natural Resources (UC ANR) invites applications for a Director of County Cooperative Extension in the Academic Administrator Series or in the Academic Coordinator III Series. Location Headquarters: This position will be located at either the ANR headquarters in Davis, CA or a county Cooperative Extension office, should there be space available. It is expected that if the successful candidate is not physically located in Davis, travel to the Davis building will be expected one to two days per month. Purpose & Clientele The Director of County Cooperative Extension provides visionary leadership, mentoring and support to the University of California County Cooperative Extension offices to ensure the successful development, delivery, evaluation, and administration of local applied research and extension programming. Through the implementation of programs and applied research, UCCE purposefully and intentionally improves the economic, environmental and social conditions in all 58 counites of California. The Director connects area and county directors (UCCE Unit Directors) and their local academic, program and administrative teams to resources, professional development, policy and financial resources to ensure the cooperative extension continuum loop between the ten UC campuses and the 58 counties. The Director provides leadership and oversight to UCCE unit directors to ensure understanding, application and implementation of the UC ANR strategic vision and statewide program/institute activities to support and strengthen UCCE units. The Director develops and coordinates professional development opportunities for UCCE unit directors related to leadership skill development, managing and supervising employees, conflict resolution, policy and reporting compliance, problem solving and celebrating successes. The Director is the primary supervisor for all UCCE unit directors and is responsible for the recruitment, on-boarding, mentoring and evaluations of this team of professionals. Primary clientele is UCCE unit directors, and secondarily their academic, programmatic and administrative employees. Major Responsibilities Leadership and Vision Lead and oversee implementation of UCCE across California. Set a high standard for excellence. Use personal knowledge and professional experience to envision the future, anticipate change, capitalize on opportunities and develop innovative options that further the strategic direction of the organization. Provide supervision and visionary leadership for the UCCE unit directors to inspire and motivate by attitude and actions through setting clear goals and targeted outputs. Model and create a positive environment that supports the success of all UCCE units and team members across California. Demonstrate concern for all staff; effectively manage all personnel, including direct supervision of all UCCE unit directors Provide coaching and guidance to UCCE unit directors in multiple functional areas, including development of local procedures and practices, academic and staff recruitment, employee and labor relations, retention, professional development, training, employee evaluation, and reporting at county, systemwide, and Federal levels. Support, mentor and advise UCCE unit directors in their supervision of UCCE advisors, staff, administrative professionals and any additional FTE in the unit (e.g., students, active emeritus CE advisors, and any additional academic positions working within the unit). Use merit, promotion, and evaluation processes to mentor, educate and provide feedback to support employee success. Provide leadership, mentoring and evaluation of UCCE unit directors and when appropriate other UCCE employees. Provide leadership to UCCE unit directors by: o Conducting and supporting annual evaluations/merits/ promotions. o Consulting and reviewing sabbatical leaves, emeritus work plans, professional development planning. o Developing and implementing plans for coaching, corrective actions, program improvement plans, and letters of expectations. o Coordinating monthly leadership update webinars and annual face-to-face professional development meetings. o Providing regular communications with all UCCE unit personnel about University and County updates and navigating both University and County human resources' policies and procedures. Model your actions and support UCCE unit directors in achieving the metrics identified in their position descriptions related to leadership, administration, finance and partnership development. In consultation with ANR leadership, make recommendations and implement decisions on programmatic, operational, workforce planning, and other pertinent issues. Develop and maintain effective professional relationships with colleagues across all local units, as well as systemwide. Liaison between County Directors, Academic Assembly Council and Staff Assembly Council. Administrative Policy Understand, uniformly apply, and ensure compliance of UC and County Administrative policies and procedures, including UC ANR Affirmative Action guidelines and policies. Provide leadership to academics and staff to ensure assessment of clientele needs. Set standards for UCCE units to measure outcomes and impacts and communicate these milestones to local clientele and stakeholders. Value and deliver high quality, professional, responsive and innovative service. Demonstrate the ability to analyze situations or problems, make timely and sound decisions, construct plans and achieve optimal results. Collaborate across organizational units as appropriate to gather and integrate information to formulate approaches to resolve issues and respond to and resolve complex and/or sensitive issues. Facilitate resolution of informal conflicts and/or complaints within UC Cooperative Extension units when requested by or involving UCCE unit directors. Budget and Funding Demonstrate evidence of successfully and effectively allocating resources, monitoring the use of resources, and reporting to funding agencies. Demonstrate integrity, accountability and efficient stewardship of university and county resources in a manner consistent with the UC Standards of Ethical conduct and other policies. Human Resource and Business Unit Relationships Collaborate with UC ANR Human Resources and Business units, on various matters impacting or pertaining to UCCE unit procedures and practices, to ensure services meet the needs of UCCE units. Facilitate communication between Business Units, Research & Extension Centers, and UCCE units. Cultivate, maintain, and nurture internal UC relationships. Collaborate with colleagues to achieve results in alignment with the operations and mission of the University of California. Advocacy and Communication Represent UC ANR and UCCE in professional manner. Ensure clientele needs are assessed. Support the development of priority program goals to successfully meet clientele needs, in alignment with UC ANR's Strategic Vision, Initiatives and Plan. Maintain positive relationships with new and existing partners, stakeholders and clientele to cultivate, maintain, and nurture political and industry relationships and resources to build new programs that expand UCCE's reach across the state. Meet with and provide responsive communications with key stakeholders (e.g., industry partners, donors, policy makers and elected officials, and others as required). Increase awareness of UCCE by disseminating information on behalf of the unit to county residents, stakeholders, clientele, and politicians. Represent UC ANR on various statewide and/or national committees and serve as the liaison between UC ANR and UCCE offices and employees. Promote active, ongoing advocacy and support of UC ANR. Collaborate with UC ANR Office of Government Affairs to support UCCE unit academics in responding to regulatory, state and federal agencies, external groups, industry organizations and the mass media on issues related to applied research and extension projects. Represent the University as a resource and contact person to industry leaders, producers, non-University of California academics and the public. Communicate needs, successes and opportunities with Government Affairs staff. Reporting Relationship: The Director for County Cooperative Extension reports directly to the Associate Vice President for Research and Cooperative Extension (AVP). Qualifications and Skills Required Required Qualifications Education: For Academic Administrator Series, a minimum of a Ph.D. or other terminal degree in disciplines related to extension education, personnel management, higher education administration education, development or related fields are required at the time of appointment. For Academic Coordinator III Series, a minimum of a Master's degree in disciplines related to extension education . click apply for full job details
04/24/2025
Full time
UC Cooperative Extension - Director of County Cooperative Extention - Academic Administrator or Academic Coordinator III Series (25-09) University of California Agriculture and Natural Resources Application Window Open date: April 14, 2025 Next review date: Wednesday, May 21, 2025 at 11:59pm (Pacific Time) Apply by this date to ensure full consideration by the committee. Final date: Friday, Jun 20, 2025 at 11:59pm (Pacific Time) Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled. Position description Position Overview The University of California, Agriculture and Natural Resources (UC ANR) invites applications for a Director of County Cooperative Extension in the Academic Administrator Series or in the Academic Coordinator III Series. Location Headquarters: This position will be located at either the ANR headquarters in Davis, CA or a county Cooperative Extension office, should there be space available. It is expected that if the successful candidate is not physically located in Davis, travel to the Davis building will be expected one to two days per month. Purpose & Clientele The Director of County Cooperative Extension provides visionary leadership, mentoring and support to the University of California County Cooperative Extension offices to ensure the successful development, delivery, evaluation, and administration of local applied research and extension programming. Through the implementation of programs and applied research, UCCE purposefully and intentionally improves the economic, environmental and social conditions in all 58 counites of California. The Director connects area and county directors (UCCE Unit Directors) and their local academic, program and administrative teams to resources, professional development, policy and financial resources to ensure the cooperative extension continuum loop between the ten UC campuses and the 58 counties. The Director provides leadership and oversight to UCCE unit directors to ensure understanding, application and implementation of the UC ANR strategic vision and statewide program/institute activities to support and strengthen UCCE units. The Director develops and coordinates professional development opportunities for UCCE unit directors related to leadership skill development, managing and supervising employees, conflict resolution, policy and reporting compliance, problem solving and celebrating successes. The Director is the primary supervisor for all UCCE unit directors and is responsible for the recruitment, on-boarding, mentoring and evaluations of this team of professionals. Primary clientele is UCCE unit directors, and secondarily their academic, programmatic and administrative employees. Major Responsibilities Leadership and Vision Lead and oversee implementation of UCCE across California. Set a high standard for excellence. Use personal knowledge and professional experience to envision the future, anticipate change, capitalize on opportunities and develop innovative options that further the strategic direction of the organization. Provide supervision and visionary leadership for the UCCE unit directors to inspire and motivate by attitude and actions through setting clear goals and targeted outputs. Model and create a positive environment that supports the success of all UCCE units and team members across California. Demonstrate concern for all staff; effectively manage all personnel, including direct supervision of all UCCE unit directors Provide coaching and guidance to UCCE unit directors in multiple functional areas, including development of local procedures and practices, academic and staff recruitment, employee and labor relations, retention, professional development, training, employee evaluation, and reporting at county, systemwide, and Federal levels. Support, mentor and advise UCCE unit directors in their supervision of UCCE advisors, staff, administrative professionals and any additional FTE in the unit (e.g., students, active emeritus CE advisors, and any additional academic positions working within the unit). Use merit, promotion, and evaluation processes to mentor, educate and provide feedback to support employee success. Provide leadership, mentoring and evaluation of UCCE unit directors and when appropriate other UCCE employees. Provide leadership to UCCE unit directors by: o Conducting and supporting annual evaluations/merits/ promotions. o Consulting and reviewing sabbatical leaves, emeritus work plans, professional development planning. o Developing and implementing plans for coaching, corrective actions, program improvement plans, and letters of expectations. o Coordinating monthly leadership update webinars and annual face-to-face professional development meetings. o Providing regular communications with all UCCE unit personnel about University and County updates and navigating both University and County human resources' policies and procedures. Model your actions and support UCCE unit directors in achieving the metrics identified in their position descriptions related to leadership, administration, finance and partnership development. In consultation with ANR leadership, make recommendations and implement decisions on programmatic, operational, workforce planning, and other pertinent issues. Develop and maintain effective professional relationships with colleagues across all local units, as well as systemwide. Liaison between County Directors, Academic Assembly Council and Staff Assembly Council. Administrative Policy Understand, uniformly apply, and ensure compliance of UC and County Administrative policies and procedures, including UC ANR Affirmative Action guidelines and policies. Provide leadership to academics and staff to ensure assessment of clientele needs. Set standards for UCCE units to measure outcomes and impacts and communicate these milestones to local clientele and stakeholders. Value and deliver high quality, professional, responsive and innovative service. Demonstrate the ability to analyze situations or problems, make timely and sound decisions, construct plans and achieve optimal results. Collaborate across organizational units as appropriate to gather and integrate information to formulate approaches to resolve issues and respond to and resolve complex and/or sensitive issues. Facilitate resolution of informal conflicts and/or complaints within UC Cooperative Extension units when requested by or involving UCCE unit directors. Budget and Funding Demonstrate evidence of successfully and effectively allocating resources, monitoring the use of resources, and reporting to funding agencies. Demonstrate integrity, accountability and efficient stewardship of university and county resources in a manner consistent with the UC Standards of Ethical conduct and other policies. Human Resource and Business Unit Relationships Collaborate with UC ANR Human Resources and Business units, on various matters impacting or pertaining to UCCE unit procedures and practices, to ensure services meet the needs of UCCE units. Facilitate communication between Business Units, Research & Extension Centers, and UCCE units. Cultivate, maintain, and nurture internal UC relationships. Collaborate with colleagues to achieve results in alignment with the operations and mission of the University of California. Advocacy and Communication Represent UC ANR and UCCE in professional manner. Ensure clientele needs are assessed. Support the development of priority program goals to successfully meet clientele needs, in alignment with UC ANR's Strategic Vision, Initiatives and Plan. Maintain positive relationships with new and existing partners, stakeholders and clientele to cultivate, maintain, and nurture political and industry relationships and resources to build new programs that expand UCCE's reach across the state. Meet with and provide responsive communications with key stakeholders (e.g., industry partners, donors, policy makers and elected officials, and others as required). Increase awareness of UCCE by disseminating information on behalf of the unit to county residents, stakeholders, clientele, and politicians. Represent UC ANR on various statewide and/or national committees and serve as the liaison between UC ANR and UCCE offices and employees. Promote active, ongoing advocacy and support of UC ANR. Collaborate with UC ANR Office of Government Affairs to support UCCE unit academics in responding to regulatory, state and federal agencies, external groups, industry organizations and the mass media on issues related to applied research and extension projects. Represent the University as a resource and contact person to industry leaders, producers, non-University of California academics and the public. Communicate needs, successes and opportunities with Government Affairs staff. Reporting Relationship: The Director for County Cooperative Extension reports directly to the Associate Vice President for Research and Cooperative Extension (AVP). Qualifications and Skills Required Required Qualifications Education: For Academic Administrator Series, a minimum of a Ph.D. or other terminal degree in disciplines related to extension education, personnel management, higher education administration education, development or related fields are required at the time of appointment. For Academic Coordinator III Series, a minimum of a Master's degree in disciplines related to extension education . click apply for full job details
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. The Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical Research or VP of Clinical Affairs will ensure that Cepheid Clinical Affairs standard operating procedures (SOPs) are compliant with current applicable regulations, laws and guidance including but not limited to the United States and Europe. This role also provides clinical compliance support for pre-market clinical studies. This position is part of the Clinical Affairs organization and will be a Remote-US based role. In this role, you will have the opportunity to: Develops and oversee the design, build and execution of a robust and global clinical affairs compliance strategy and program including internal GCP auditing (i.e., TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR compliance across Clinical Affairs. Provides leadership to managers and professional associates and is accountable for the performance and results of multiple related teams. Apply thorough knowledge of current international requirements of GCP, GLP, FDA, ICH, CE, and applicable global regulations to ensure all Clinical Affairs department standard operating procedures (SOPs) and clinical templates are maintained in a high state of compliance. Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals. Evaluation, acquisition, and implementation of systems to support Clinical Affairs activities. (i.e., CTMS, Smartsheets, etc.) and to ensure compliance with applicable international and national standards, regulations, and guidelines (i.e., 21CRF Part 11, etc.) Persuade managers and leaders, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups. The essential requirements of the job include: Bachelor's degree in science with 14+ years of clinical quality/GCP experience within the device industry OR Master's degree in science with 12+ years of clinical quality/GCP experience within the device industry Knowledge of US requirements and regulations related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies Proven track record of managing successful clinical audits and define/support non-conformances and CAPA Ability to build strong relationships and trust with global internal and external stakeholders 4+ years managing people It would be a plus if you also possess previous experience in: Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America) FDA audit (e.g., BIMO) process Physical Demands: Must be able to travel approximately 10% The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at . At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. The salary range for this role is $140,600-200,300. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
04/24/2025
Full time
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. The Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical Research or VP of Clinical Affairs will ensure that Cepheid Clinical Affairs standard operating procedures (SOPs) are compliant with current applicable regulations, laws and guidance including but not limited to the United States and Europe. This role also provides clinical compliance support for pre-market clinical studies. This position is part of the Clinical Affairs organization and will be a Remote-US based role. In this role, you will have the opportunity to: Develops and oversee the design, build and execution of a robust and global clinical affairs compliance strategy and program including internal GCP auditing (i.e., TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR compliance across Clinical Affairs. Provides leadership to managers and professional associates and is accountable for the performance and results of multiple related teams. Apply thorough knowledge of current international requirements of GCP, GLP, FDA, ICH, CE, and applicable global regulations to ensure all Clinical Affairs department standard operating procedures (SOPs) and clinical templates are maintained in a high state of compliance. Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals. Evaluation, acquisition, and implementation of systems to support Clinical Affairs activities. (i.e., CTMS, Smartsheets, etc.) and to ensure compliance with applicable international and national standards, regulations, and guidelines (i.e., 21CRF Part 11, etc.) Persuade managers and leaders, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups. The essential requirements of the job include: Bachelor's degree in science with 14+ years of clinical quality/GCP experience within the device industry OR Master's degree in science with 12+ years of clinical quality/GCP experience within the device industry Knowledge of US requirements and regulations related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies Proven track record of managing successful clinical audits and define/support non-conformances and CAPA Ability to build strong relationships and trust with global internal and external stakeholders 4+ years managing people It would be a plus if you also possess previous experience in: Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America) FDA audit (e.g., BIMO) process Physical Demands: Must be able to travel approximately 10% The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at . At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. The salary range for this role is $140,600-200,300. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
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.