CLevelCrossing
Vice President Global Strategic Regulatory Operations GRSO
CLevelCrossing, Princeton, New Jersey, us, 08543
Vice President Global Strategic Regulatory Operations GRSO
Location: Princeton, NJ, United States Posted on: Jun 23, 2020 Profile At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Summary: The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. This position has accountabilities for the sustained health, growth, and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise. This role sets strategic direction and is accountable for delivering all global regulatory services for all BMS products. Responsibilities: Strategic leadership of the units responsible for the design, authoring, and writing of scientific documents that support regulatory submissions globally; the management and publishing of these documents and dossiers for compliant and high-quality global submissions, labeling creation, and labeling operational support globally. Ensure adequate procedures and policies are in place to support compliance with global regulatory standards for regulatory documents, submissions, and other services (i.e. electronic submissions). Leadership of the central regulatory team that provides strategic oversight to the Mature Brands regulatory services provided by vendors. Accountable for the business capabilities (systems and processes) that support these activities, including ERBM and other regulatory information management systems; driving strategic outsourcing in the provision of these services, balancing cost, quality, risk, and speed to patient. Responsible for oversight and development of Global Regulatory Team Leads for LCM assets. Provide strategic senior regulatory approval of the strategies, submissions plans, and HA interaction plans for these assets. Responsible for monitoring and assessing external trends to inform and educate stakeholders including macro trends in regulatory agencies globally, the healthcare environment, therapeutic area market, and brand business drivers. Qualifications: MD, PhD, Pharm D or advanced scientific educational equivalent. Extensive experience in Global Regulatory Sciences including the management of global regulatory operational services. Extensive experience in team management at the department level; with proven ability to manage large change initiatives successfully. Proven track record in the delivery of successful regulatory strategies working with development teams and regulatory agencies globally. Broad intelligence of regulatory environment across key regions, anticipation of future trends and impact. Excellent cross-functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships. Strong influencing/persuasive skills with a demonstrated ability to influence different styles and individuals at different levels in the organization. Exceptional collaboration and analytical skills to ensure that emerging trends are well assessed and vetted for potential business implications. Experience leading a matrix organization in an ambiguous environment with frequently changing priorities. Strong knowledge of the Healthcare environment, including political, regulatory, and healthcare reform concerns. Strong budget management skills. Strong program management skills and experience leading large teams with complex and matrixed initiatives. Strong leadership and engagement skills. Experience managing employees and matrix teams in a fast-paced environment. Creates a sense of purpose or vision for self, department, and leadership team. Translates broad strategies into specific objectives and action plans. Sets challenging, but achievable objectives. Generates alternatives and assesses benefits and risks. Allocates resources according to strategic priorities. Makes critical choices that support strategy and ultimately the end-customer. Aligns personal, team, and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them. Creates a unified and seamless team. Provides direction to others that clarifies their expectations and role. Communicates opinions, facts, and thoughts with clarity, transparency, and honesty. Seeks multiple perspectives and listens openly to others' points of view. Enables and demonstrates the courage to speak up on issues and risks as well as on the good news. Creates an environment that encourages continuous improvement, innovation, and appropriate risk-taking. Focuses the organization on key priorities that impact our business. Adapts to and/or drives positive change. Removes barriers and eliminates non-value-added work. Demonstrates resilience and perseverance. Continuously builds a high-performance diverse team of people to achieve objectives. Develops self and others to improve performance in the current role and to prepare for future roles. Seeks and welcomes feedback and responds to coaching. Provides frequent feedback and coaching to others on ways to improve performance. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Company: Bristol-Myers Squibb Req Number: R1526734_EN Updated: 2020-06-23 00:00:00.000 UTC Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Location: Princeton, NJ, United States Posted on: Jun 23, 2020 Profile At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Summary: The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. This position has accountabilities for the sustained health, growth, and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise. This role sets strategic direction and is accountable for delivering all global regulatory services for all BMS products. Responsibilities: Strategic leadership of the units responsible for the design, authoring, and writing of scientific documents that support regulatory submissions globally; the management and publishing of these documents and dossiers for compliant and high-quality global submissions, labeling creation, and labeling operational support globally. Ensure adequate procedures and policies are in place to support compliance with global regulatory standards for regulatory documents, submissions, and other services (i.e. electronic submissions). Leadership of the central regulatory team that provides strategic oversight to the Mature Brands regulatory services provided by vendors. Accountable for the business capabilities (systems and processes) that support these activities, including ERBM and other regulatory information management systems; driving strategic outsourcing in the provision of these services, balancing cost, quality, risk, and speed to patient. Responsible for oversight and development of Global Regulatory Team Leads for LCM assets. Provide strategic senior regulatory approval of the strategies, submissions plans, and HA interaction plans for these assets. Responsible for monitoring and assessing external trends to inform and educate stakeholders including macro trends in regulatory agencies globally, the healthcare environment, therapeutic area market, and brand business drivers. Qualifications: MD, PhD, Pharm D or advanced scientific educational equivalent. Extensive experience in Global Regulatory Sciences including the management of global regulatory operational services. Extensive experience in team management at the department level; with proven ability to manage large change initiatives successfully. Proven track record in the delivery of successful regulatory strategies working with development teams and regulatory agencies globally. Broad intelligence of regulatory environment across key regions, anticipation of future trends and impact. Excellent cross-functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships. Strong influencing/persuasive skills with a demonstrated ability to influence different styles and individuals at different levels in the organization. Exceptional collaboration and analytical skills to ensure that emerging trends are well assessed and vetted for potential business implications. Experience leading a matrix organization in an ambiguous environment with frequently changing priorities. Strong knowledge of the Healthcare environment, including political, regulatory, and healthcare reform concerns. Strong budget management skills. Strong program management skills and experience leading large teams with complex and matrixed initiatives. Strong leadership and engagement skills. Experience managing employees and matrix teams in a fast-paced environment. Creates a sense of purpose or vision for self, department, and leadership team. Translates broad strategies into specific objectives and action plans. Sets challenging, but achievable objectives. Generates alternatives and assesses benefits and risks. Allocates resources according to strategic priorities. Makes critical choices that support strategy and ultimately the end-customer. Aligns personal, team, and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them. Creates a unified and seamless team. Provides direction to others that clarifies their expectations and role. Communicates opinions, facts, and thoughts with clarity, transparency, and honesty. Seeks multiple perspectives and listens openly to others' points of view. Enables and demonstrates the courage to speak up on issues and risks as well as on the good news. Creates an environment that encourages continuous improvement, innovation, and appropriate risk-taking. Focuses the organization on key priorities that impact our business. Adapts to and/or drives positive change. Removes barriers and eliminates non-value-added work. Demonstrates resilience and perseverance. Continuously builds a high-performance diverse team of people to achieve objectives. Develops self and others to improve performance in the current role and to prepare for future roles. Seeks and welcomes feedback and responds to coaching. Provides frequent feedback and coaching to others on ways to improve performance. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Company: Bristol-Myers Squibb Req Number: R1526734_EN Updated: 2020-06-23 00:00:00.000 UTC Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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