BioSpace
Senior Director, Business Process Owner, Medical Safety Sciences
BioSpace, Boston, Massachusetts, us, 02298
Senior Director, Business Process Owner, Medical Safety Sciences
Join to apply for the
Senior Director, Business Process Owner, Medical Safety Sciences
role at
BioSpace 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. Overview
About the role:
Primarily responsible for the design, procedural documentation, implementation, management, and oversight of the Reference Safety Information (RSI) end-to-end process in QMS and other business guidance documents. As needed, scope of responsibilities may expand to other end-to-end processes or projects owned by Medical Safety Sciences, PSPV (including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports). Responsible for developing the roadmap and implementation plan for bringing key support functions including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports, including communications. Overseeing implementation of related processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs). How You Will Contribute
Accountable for setting the strategy direction of the end-to-end process to deliver business benefits. Accountable for developing, authoring, maintaining, & approving procedural documents, templates/forms, training materials, and other toolkit (e.g. operating model, business guidance document). Accountable as the Business Process Owner SME in audits and inspection readiness activities. Responsible for frequent and regular review of the process, designing continuous improvement, defining compliance KPIs, and implementing CAPA-related to audits and inspections findings. Responsible for leading and conducting process impact assessments in response to changes in regulatory requirements identified through Takeda’s regulatory intelligence activities, and for implementing appropriate changes to ensure compliance with new regulatory requirements. Responsible for liaising and driving collaboration with other stakeholders (peer function, cross-functions, quality), ensuring cross-functional alignment of the process, and escalating issues to governance. Responsible for driving and implementing system-related solutions to ensure end-to-end oversight. Responsible for keeping abreast of best practices, including industry trends, technological developments, and vendor landscape, to identify potential use cases. Responsible for ensuring adequate training, coaching, and mentoring of supervised employees (direct and indirect reports) to create a culture that attracts, retains, and develops innovative thinkers and acts as a role model for Takeda’s values. Responsible for leading or supporting initiatives or projects improving end-to-end processes or quality of Medical Safety Sciences activities, where applicable. Technical/Functional (Line) Expertise
Deep knowledge and subject matter expertise on the existing end-to-end process(es). Comprehensive understanding of ICH, MHRA, and other regulatory intelligence. Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment. Leadership
Provides clear direction on requirements to meet the expectations of all business stakeholders. Capable of reconciling conflicting views into a cohesive path forward. Demonstrated ability to work across functions, regions, and cultures. Enterprise-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 distill complex issues and ideas down to simple comprehensible terms. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Decision-making And Autonomy
Cross-functional collaboration: able to synthesize diverse inputs from multiple constituents and stakeholders to drive innovative solutions. Accountable for decision-making for the designated function. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution. Accountable for designing and implementing vision and strategy for designated scope. Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace. Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions. Innovation
Comfortable challenging the status quo and bringing forward innovative solutions. Recognize the opportunity to improve the process to achieve business benefit. Identify and manage interdependence across processes. Complexity
Ability to work in a global ecosystem (internal and external) with a high degree of complexity. Breadth of knowledge required across therapeutic areas, indications, and/or modalities. Skills And Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, with a focus on clinical drug development including but not limited to Pharmacovigilance. Experience in people leadership, managing matrix teams, and coordinating collaboration with cross-functional teams. Strong strategic thinking, planning, execution, and communication skills. Global/international experience required, including the ability to collaborate with colleagues and staff in other locations. Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location:
Boston, MA U.S. Base Salary Range
$208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives and various benefits (medical, dental, vision insurance, 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, and paid time off). EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran, in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations : Boston, MA; Zurich, Switzerland Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Referrals increase your chances of interviewing at BioSpace. Get notified about new Director Business Process jobs in Boston, MA.
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Join to apply for the
Senior Director, Business Process Owner, Medical Safety Sciences
role at
BioSpace 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. Overview
About the role:
Primarily responsible for the design, procedural documentation, implementation, management, and oversight of the Reference Safety Information (RSI) end-to-end process in QMS and other business guidance documents. As needed, scope of responsibilities may expand to other end-to-end processes or projects owned by Medical Safety Sciences, PSPV (including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports). Responsible for developing the roadmap and implementation plan for bringing key support functions including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports, including communications. Overseeing implementation of related processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs). How You Will Contribute
Accountable for setting the strategy direction of the end-to-end process to deliver business benefits. Accountable for developing, authoring, maintaining, & approving procedural documents, templates/forms, training materials, and other toolkit (e.g. operating model, business guidance document). Accountable as the Business Process Owner SME in audits and inspection readiness activities. Responsible for frequent and regular review of the process, designing continuous improvement, defining compliance KPIs, and implementing CAPA-related to audits and inspections findings. Responsible for leading and conducting process impact assessments in response to changes in regulatory requirements identified through Takeda’s regulatory intelligence activities, and for implementing appropriate changes to ensure compliance with new regulatory requirements. Responsible for liaising and driving collaboration with other stakeholders (peer function, cross-functions, quality), ensuring cross-functional alignment of the process, and escalating issues to governance. Responsible for driving and implementing system-related solutions to ensure end-to-end oversight. Responsible for keeping abreast of best practices, including industry trends, technological developments, and vendor landscape, to identify potential use cases. Responsible for ensuring adequate training, coaching, and mentoring of supervised employees (direct and indirect reports) to create a culture that attracts, retains, and develops innovative thinkers and acts as a role model for Takeda’s values. Responsible for leading or supporting initiatives or projects improving end-to-end processes or quality of Medical Safety Sciences activities, where applicable. Technical/Functional (Line) Expertise
Deep knowledge and subject matter expertise on the existing end-to-end process(es). Comprehensive understanding of ICH, MHRA, and other regulatory intelligence. Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment. Leadership
Provides clear direction on requirements to meet the expectations of all business stakeholders. Capable of reconciling conflicting views into a cohesive path forward. Demonstrated ability to work across functions, regions, and cultures. Enterprise-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 distill complex issues and ideas down to simple comprehensible terms. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Decision-making And Autonomy
Cross-functional collaboration: able to synthesize diverse inputs from multiple constituents and stakeholders to drive innovative solutions. Accountable for decision-making for the designated function. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution. Accountable for designing and implementing vision and strategy for designated scope. Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace. Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions. Innovation
Comfortable challenging the status quo and bringing forward innovative solutions. Recognize the opportunity to improve the process to achieve business benefit. Identify and manage interdependence across processes. Complexity
Ability to work in a global ecosystem (internal and external) with a high degree of complexity. Breadth of knowledge required across therapeutic areas, indications, and/or modalities. Skills And Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, with a focus on clinical drug development including but not limited to Pharmacovigilance. Experience in people leadership, managing matrix teams, and coordinating collaboration with cross-functional teams. Strong strategic thinking, planning, execution, and communication skills. Global/international experience required, including the ability to collaborate with colleagues and staff in other locations. Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location:
Boston, MA U.S. Base Salary Range
$208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives and various benefits (medical, dental, vision insurance, 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, and paid time off). EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran, in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations : Boston, MA; Zurich, Switzerland Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Referrals increase your chances of interviewing at BioSpace. Get notified about new Director Business Process jobs in Boston, MA.
#J-18808-Ljbffr