BioSpace, Inc.
Associate Director, Safety Deliverable Excellence (Hybrid)
BioSpace, Inc., North Chicago, Illinois, us, 60086
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
This role is primarily responsible for driving safety deliverable excellence, and accountable to oversee timely completion and submission of safety deliverables within assigned team, assuring associated deliverable quality expectations are met. In addition, this role works as part of the Safety Deliverable Excellence Leadership Team, to develop, implement, maintain and monitor optimized processes for, and quality execution of, Safety Deliverables.
Responsibilities:Managerial oversight of assigned internal and external employees/resources; delegates effectively, with oversight, to empower, leverage and develop staff. Responsible for building and nurturing a culture of safety deliverable excellence.Contribute to, and support implementation of, Safety Deliverable Excellence vision, strategies, and objectives (deliverable quality, timeliness and efficiencies).Conceive, lead and/or contribute to major process improvements, system enhancements, or other projects impacting PPS Safety Deliverables. Provide execution leadership to direct reports for all initiatives related to safety deliverable excellence.Build strong strategic partnerships with stakeholders and leverage relationships to advance the Safety Deliverable Excellence vision and to drive consistent stakeholder understanding and application of quality principles related to safety deliverables.Responsible for audit and inspection preparation strategy and execution activities (related to safety deliverables). Leads and oversees responses to audit requests. Acts as a subject matter expert where required and may be interviewed during audits and inspections.Interpret current and emerging guidance and regulations that impact PST safety deliverables.Identify and drive recommended actions (where applicable) to ensure compliance with regulations.In collaboration with the Business Process Owner (BPO) office, create (and update as appropriate), manage, and monitor: safety deliverable processes, guidelines and templates, and compliance and performance metrics. Seeks to understand non-compliance issues and root causes and implement measures to address gaps.Strategic management and oversight of PST safety deliverables, as needed, including development of PST safety deliverable strategies, project plans, confirming accountabilities, driving document quality, completion of actions and escalating obstacles/risks.Significant Work Activities
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
Qualifications:
Required Education: Bachelors degree (with related health science discipline preferred)Minimum of 3 years pharmaceutical industry experience or equivalent experience in a regulated industry.Demonstrated knowledge of safety deliverable development, requirements, and associated regulations.Demonstrated people management experience preferred.Strong leadership presence. Ability to work directly with and influence senior management. Decisive yet collaborative leadership style.Proven ability to lead, manage and motivate others in a complex, multi-functional matrix environment preferred.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.This job is eligible to participate in our short-term incentiveprograms.This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
This role is primarily responsible for driving safety deliverable excellence, and accountable to oversee timely completion and submission of safety deliverables within assigned team, assuring associated deliverable quality expectations are met. In addition, this role works as part of the Safety Deliverable Excellence Leadership Team, to develop, implement, maintain and monitor optimized processes for, and quality execution of, Safety Deliverables.
Responsibilities:Managerial oversight of assigned internal and external employees/resources; delegates effectively, with oversight, to empower, leverage and develop staff. Responsible for building and nurturing a culture of safety deliverable excellence.Contribute to, and support implementation of, Safety Deliverable Excellence vision, strategies, and objectives (deliverable quality, timeliness and efficiencies).Conceive, lead and/or contribute to major process improvements, system enhancements, or other projects impacting PPS Safety Deliverables. Provide execution leadership to direct reports for all initiatives related to safety deliverable excellence.Build strong strategic partnerships with stakeholders and leverage relationships to advance the Safety Deliverable Excellence vision and to drive consistent stakeholder understanding and application of quality principles related to safety deliverables.Responsible for audit and inspection preparation strategy and execution activities (related to safety deliverables). Leads and oversees responses to audit requests. Acts as a subject matter expert where required and may be interviewed during audits and inspections.Interpret current and emerging guidance and regulations that impact PST safety deliverables.Identify and drive recommended actions (where applicable) to ensure compliance with regulations.In collaboration with the Business Process Owner (BPO) office, create (and update as appropriate), manage, and monitor: safety deliverable processes, guidelines and templates, and compliance and performance metrics. Seeks to understand non-compliance issues and root causes and implement measures to address gaps.Strategic management and oversight of PST safety deliverables, as needed, including development of PST safety deliverable strategies, project plans, confirming accountabilities, driving document quality, completion of actions and escalating obstacles/risks.Significant Work Activities
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
Qualifications:
Required Education: Bachelors degree (with related health science discipline preferred)Minimum of 3 years pharmaceutical industry experience or equivalent experience in a regulated industry.Demonstrated knowledge of safety deliverable development, requirements, and associated regulations.Demonstrated people management experience preferred.Strong leadership presence. Ability to work directly with and influence senior management. Decisive yet collaborative leadership style.Proven ability to lead, manage and motivate others in a complex, multi-functional matrix environment preferred.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.This job is eligible to participate in our short-term incentiveprograms.This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html