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Most recent job postings at AbbVie
via AbbVie Careers
posted_at: 18 days agoschedule_type: Full-time
Responsibilities
• Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. to meet or exceed on those objectives.
• Create pre-call plan objectives and execute post-call evaluation to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action to close on every sales... call.
• Proactively and continuously aspire to
Responsibilities
• Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. to meet or exceed on those objectives.
• Create pre-call plan objectives and execute post-call evaluation to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action to close on every sales... call.
• Proactively and continuously aspire to serve customer needs, customer expectations and challenges to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers.
• Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers to maximize access and sales opportunities.
• Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution.
• Differentiate AbbVie’s value proposition with health providers assigned and identify, develop, and maintain disease state experts and speakers/advocates to maximize brand performance.
Qualifications
• Bachelor's degree, biological sciences, pharmacy, business related field, or equivalent
• Proven track record of success in selling and solid presentation skills.
• Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities.
• Proactively identifies customer style / behavior and quickly adapts to all aspects of selling approach. Understands and leverages findings to develop sales strategies.
• Operates effectively in a matrix environment.
• Offers innovative ideas and solutions to maximize business opportunities to address challenges.
• Provides impact with ideas for the larger organization and anticipates and responds to changes.
• Influences others and is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc.
• Leads by example; Consistently displays positive behaviors and peer coaching through changing and challenging environments. Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels.
• Preferred: Proven track record of success in sales performance within respective therapeutic areas. Commercial pharmaceutical industry experiences such as physician/account-based selling, training, managed health care or marketing preferred. English language proficiency verbally and in writing (for all non-English speaking countries).
US Credentialing Requirement:
An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have regarding your responsibilities.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
• Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. to meet or exceed on those objectives.
• Create pre-call plan objectives and execute post-call evaluation to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action to close on every sales... call.
• Proactively and continuously aspire to serve customer needs, customer expectations and challenges to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers.
• Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers to maximize access and sales opportunities.
• Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution.
• Differentiate AbbVie’s value proposition with health providers assigned and identify, develop, and maintain disease state experts and speakers/advocates to maximize brand performance.
Qualifications
• Bachelor's degree, biological sciences, pharmacy, business related field, or equivalent
• Proven track record of success in selling and solid presentation skills.
• Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities.
• Proactively identifies customer style / behavior and quickly adapts to all aspects of selling approach. Understands and leverages findings to develop sales strategies.
• Operates effectively in a matrix environment.
• Offers innovative ideas and solutions to maximize business opportunities to address challenges.
• Provides impact with ideas for the larger organization and anticipates and responds to changes.
• Influences others and is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc.
• Leads by example; Consistently displays positive behaviors and peer coaching through changing and challenging environments. Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels.
• Preferred: Proven track record of success in sales performance within respective therapeutic areas. Commercial pharmaceutical industry experiences such as physician/account-based selling, training, managed health care or marketing preferred. English language proficiency verbally and in writing (for all non-English speaking countries).
US Credentialing Requirement:
An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have regarding your responsibilities.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 6 days agoschedule_type: Full-time
AbbVie is looking for a security architect with experience in mergers and acquisitions to join our Information Security Strategy and Intelligence group.
AbbVie’s Information Security group engages with our partnership management teams through several stages of a company relationship, whether it’s a research-sharing relationship or an acquisition. We provide advisory services to reduce both risk... and technical friction in these transactions.
As
AbbVie is looking for a security architect with experience in mergers and acquisitions to join our Information Security Strategy and Intelligence group.
AbbVie’s Information Security group engages with our partnership management teams through several stages of a company relationship, whether it’s a research-sharing relationship or an acquisition. We provide advisory services to reduce both risk... and technical friction in these transactions.
As a security architect, your will act as a single-point-of-contact between security and other technical and business teams, operating across both operational and strategic levels, developing and coordinating design and advisory responsibilities with different areas of the information security group on individual acquisitions and research ventures. You will interact with internal research and business intelligence teams, technical teams, and other members of the information security group to develop and deliver security products and services. You will play a key role in further shaping the services this program is delivering, while ensuring in-flight acquisitions have the right security services provided at the right times.
This role will reside within the Cyber Threat Intelligence team, with a “dotted-line” relationship with our security architecture group.
Responsibilities:
· Partner with infrastructure and technology teams, security teams, and acquisition target teams to coordinate core security and tech services during an acquisition or divestiture
· Partnering with infrastructure, tech and security teams to develop, document, and deploy secure design patterns for collaborations with strategic alliance partners
· Partner with internal security and technical teams to develop new security playbooks and services focused on business alliances and strategic acquisitions
Ideal candidates will have practical experience in a relevant discipline of security architecture (Cloud Security, AppSec, Network Security, Identity), and can speak to practical solutions they have designed and successfully implemented. Experience in the following is preferred:
· Bachelor's Degree with 9 years' experience with at least five years’ experience in an information security role, preferably as a Security Architect or Security Engineer
· Direct experience with designing and/or providing solutions related to mergers, acquisitions, divestitures, and/or multi-company collaborations
· Experience with a variety of security tooling and capabilities, preferably with some hands-on/operational exposure (self-hosted and cloud)
· Working knowledge of popular cloud platforms and associated security solutions (AWS, GCP, Azure) and collaboration platforms (M365, Slack)
· Working knowledge of Active Directory and related security constructs (domains, forests, trusts, etc.)
· A solid understanding of industry security standards, such as NIST 800, ISO 27001, etc.
· Related technical/industry certifications (e.g. SANS, AWS, etc.)
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
AbbVie’s Information Security group engages with our partnership management teams through several stages of a company relationship, whether it’s a research-sharing relationship or an acquisition. We provide advisory services to reduce both risk... and technical friction in these transactions.
As a security architect, your will act as a single-point-of-contact between security and other technical and business teams, operating across both operational and strategic levels, developing and coordinating design and advisory responsibilities with different areas of the information security group on individual acquisitions and research ventures. You will interact with internal research and business intelligence teams, technical teams, and other members of the information security group to develop and deliver security products and services. You will play a key role in further shaping the services this program is delivering, while ensuring in-flight acquisitions have the right security services provided at the right times.
This role will reside within the Cyber Threat Intelligence team, with a “dotted-line” relationship with our security architecture group.
Responsibilities:
· Partner with infrastructure and technology teams, security teams, and acquisition target teams to coordinate core security and tech services during an acquisition or divestiture
· Partnering with infrastructure, tech and security teams to develop, document, and deploy secure design patterns for collaborations with strategic alliance partners
· Partner with internal security and technical teams to develop new security playbooks and services focused on business alliances and strategic acquisitions
Ideal candidates will have practical experience in a relevant discipline of security architecture (Cloud Security, AppSec, Network Security, Identity), and can speak to practical solutions they have designed and successfully implemented. Experience in the following is preferred:
· Bachelor's Degree with 9 years' experience with at least five years’ experience in an information security role, preferably as a Security Architect or Security Engineer
· Direct experience with designing and/or providing solutions related to mergers, acquisitions, divestitures, and/or multi-company collaborations
· Experience with a variety of security tooling and capabilities, preferably with some hands-on/operational exposure (self-hosted and cloud)
· Working knowledge of popular cloud platforms and associated security solutions (AWS, GCP, Azure) and collaboration platforms (M365, Slack)
· Working knowledge of Active Directory and related security constructs (domains, forests, trusts, etc.)
· A solid understanding of industry security standards, such as NIST 800, ISO 27001, etc.
· Related technical/industry certifications (e.g. SANS, AWS, etc.)
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 3 days agoschedule_type: Full-time
• Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging... issues. Oversees project-related education of
• Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging... issues. Oversees project-related education of investigators, study site personnel.
• Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned.
• Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
• May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
• Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills
• Ability to exercise judgment and address complex problems and create solutions across multiple projects.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
• Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned.
• Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
• May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
• Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills
• Ability to exercise judgment and address complex problems and create solutions across multiple projects.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 5 days agoschedule_type: Full-time
This role supports the Patient Engagement organization in the design, development and delivery of training solutions to a field and call center team organization. Accountable to ensure that adherence to vision of providing an enhanced patient experience is represented in all training programs and solutions.
Key Responsibilities Include...
• Designs, develops, and delivers learning solutions that increases effectiveness and credibility of participants
This role supports the Patient Engagement organization in the design, development and delivery of training solutions to a field and call center team organization. Accountable to ensure that adherence to vision of providing an enhanced patient experience is represented in all training programs and solutions.
Key Responsibilities Include...
• Designs, develops, and delivers learning solutions that increases effectiveness and credibility of participants by adhering to adult learning principles and sound training design.
• Demonstrates the ability to effectively address challenges in the classroom setting (live / virtual) so that the entire class can benefit and learn.
• Provides candid and specific verbal performance feedback including a plan for improved performance throughout the training.
• Actively sets mutual expectations with key stakeholders, including the field and home office groups, so that trusted working relationships are constructive and productive.
• Demonstrates and applies knowledge of all Business Partners (e.g. marketing, field leadership) businesses, strategies, and links solutions to defined business partner/brand strategies in the classroom, at meetings, and in the field.
• Helps develop Guest Trainers by providing them a meaningful role in the class, one-to-one coaching including performance feedback and acts as a mentor to other National Trainer maintaining positive peer-to-peer relationships.
• Demonstrates ability to build relationships with third parties using good negotiation skills.
• Demonstrates ability to develop and execute plans in an independent environment.
Basic:
• Bachelor’s degree required.
• Advanced knowledge and exposure to science or health sciences is necessary to successfully design and develop training content that supports pharmaceutical product / disease state knowledge.
• Knowledge of applicable regulations and standards affecting Pharmaceutical products.
• 3 years of patient support service experience with a proven high performing track record and strong understanding of what drives success in a commercial organization.
• Demonstrated ability to work with a variety of individuals at all levels of management to gain consensus on training program development and delivery.
• Learning agility to adapt to new products, markets, and develop innovative approaches.
• Demonstrated ability to be adaptable to changing work environments and responsibilities.
• Fully competent in MS Office (Word, Excel, PowerPoint) and iPad technology.
Preferred:
• Curriculum design experience
• Project management experience
US Credentialing Requirement
An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have regarding your responsibilities.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
Key Responsibilities Include...
• Designs, develops, and delivers learning solutions that increases effectiveness and credibility of participants by adhering to adult learning principles and sound training design.
• Demonstrates the ability to effectively address challenges in the classroom setting (live / virtual) so that the entire class can benefit and learn.
• Provides candid and specific verbal performance feedback including a plan for improved performance throughout the training.
• Actively sets mutual expectations with key stakeholders, including the field and home office groups, so that trusted working relationships are constructive and productive.
• Demonstrates and applies knowledge of all Business Partners (e.g. marketing, field leadership) businesses, strategies, and links solutions to defined business partner/brand strategies in the classroom, at meetings, and in the field.
• Helps develop Guest Trainers by providing them a meaningful role in the class, one-to-one coaching including performance feedback and acts as a mentor to other National Trainer maintaining positive peer-to-peer relationships.
• Demonstrates ability to build relationships with third parties using good negotiation skills.
• Demonstrates ability to develop and execute plans in an independent environment.
Basic:
• Bachelor’s degree required.
• Advanced knowledge and exposure to science or health sciences is necessary to successfully design and develop training content that supports pharmaceutical product / disease state knowledge.
• Knowledge of applicable regulations and standards affecting Pharmaceutical products.
• 3 years of patient support service experience with a proven high performing track record and strong understanding of what drives success in a commercial organization.
• Demonstrated ability to work with a variety of individuals at all levels of management to gain consensus on training program development and delivery.
• Learning agility to adapt to new products, markets, and develop innovative approaches.
• Demonstrated ability to be adaptable to changing work environments and responsibilities.
• Fully competent in MS Office (Word, Excel, PowerPoint) and iPad technology.
Preferred:
• Curriculum design experience
• Project management experience
US Credentialing Requirement
An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have regarding your responsibilities.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 4 days agoschedule_type: Full-time
AbbVie is looking for a Senior Scientist II, Engineering to join their Combination Product Development team in R&D. This individual will contribute engineering principles to the development and launch of exciting new drug / device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on... people’s lives.
As a Senior Scientist II, Engineering,
AbbVie is looking for a Senior Scientist II, Engineering to join their Combination Product Development team in R&D. This individual will contribute engineering principles to the development and launch of exciting new drug / device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on... people’s lives.
As a Senior Scientist II, Engineering, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance with a focus on device testing and analysis. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of drug delivery systems from syringes to autoinjectors to complex electromechanical pumps. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.
The position is based in Lake County, IL, US.
Responsibilities:
You will be responsible to contribute to broadening the understanding and implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Verification activities amongst others. It is expected that the engineering activities may be done internally and externally. The external engineering activities will require you to develop and foster relationships with engineering service providers and key partners during the development process.
Responsible for developing verification strategies for delivery systems and combination products that satisfy compliance to international standards and regulatory agency expectations. Requires strong cross-functional collaboration to ensure development activities translate to unambiguous and feasible verification methods based on internal and external capabilities. Author verification plans, protocols, records, and reports. Support investigations and issue resolutions. Coordinate testing across multiple test executors and manage test schedules.
Design and execute experiments supporting feasibility, development, and verification stages of product development, test method development, analyze data, document studies, and present results to cross-functional teams. Support lab equipment/software capabilities by authoring SOPs and qualification packages, developing training, troubleshooting issues, and leading audit trail reviews.
Provide technical leadership in your areas of responsibility and ensure the test design and documentation meet all regulatory compliance requirements. It is expected at this level that you contribute to raising the bar to how we execute in combination product development. This includes the identification and leadership of improvement initiatives, coaching / training individuals, look for new ideas to stimulate innovation and connect unrelated concepts, ownership as CPD SME of development systems and software.
Basic:
• Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
• Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Experience through full product development from initial concept to release-to-market is required.
• Expertise in product development from initial concept to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.
• Significant documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports. Expertise with Electronic Lab Notebooks (ELN) and Design History File tools such as Polarian/LinkUs is preferred.
• Expertise in statistical analysis is required with preferred knowledge of Minitab Statistical Software.
• Experience with equipment qualification as well as test method development and validation.
• Experience with flow accuracy measurement of electromechanical devices according to IEC 60601 – using equipment such as analytical balances, Viscometers, Climate Chambers, etc. is strongly preferred. Familiarity with software such as MATLAB, LabVIEW, Visual Basics, etc. is a plus.
• Candidate should be self-driven with strong analytical and communication (spoken and written) skills to help identify project risks and develop mitigation plans as well as support internal decision making.
• This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.
• Must have demonstrated technical leadership and ownership, and the ability to provide guidance and direction to less experienced technical personnel.
• Travel will be required, as necessary (10%).
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
As a Senior Scientist II, Engineering, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance with a focus on device testing and analysis. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of drug delivery systems from syringes to autoinjectors to complex electromechanical pumps. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.
The position is based in Lake County, IL, US.
Responsibilities:
You will be responsible to contribute to broadening the understanding and implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Verification activities amongst others. It is expected that the engineering activities may be done internally and externally. The external engineering activities will require you to develop and foster relationships with engineering service providers and key partners during the development process.
Responsible for developing verification strategies for delivery systems and combination products that satisfy compliance to international standards and regulatory agency expectations. Requires strong cross-functional collaboration to ensure development activities translate to unambiguous and feasible verification methods based on internal and external capabilities. Author verification plans, protocols, records, and reports. Support investigations and issue resolutions. Coordinate testing across multiple test executors and manage test schedules.
Design and execute experiments supporting feasibility, development, and verification stages of product development, test method development, analyze data, document studies, and present results to cross-functional teams. Support lab equipment/software capabilities by authoring SOPs and qualification packages, developing training, troubleshooting issues, and leading audit trail reviews.
Provide technical leadership in your areas of responsibility and ensure the test design and documentation meet all regulatory compliance requirements. It is expected at this level that you contribute to raising the bar to how we execute in combination product development. This includes the identification and leadership of improvement initiatives, coaching / training individuals, look for new ideas to stimulate innovation and connect unrelated concepts, ownership as CPD SME of development systems and software.
Basic:
• Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
• Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Experience through full product development from initial concept to release-to-market is required.
• Expertise in product development from initial concept to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.
• Significant documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports. Expertise with Electronic Lab Notebooks (ELN) and Design History File tools such as Polarian/LinkUs is preferred.
• Expertise in statistical analysis is required with preferred knowledge of Minitab Statistical Software.
• Experience with equipment qualification as well as test method development and validation.
• Experience with flow accuracy measurement of electromechanical devices according to IEC 60601 – using equipment such as analytical balances, Viscometers, Climate Chambers, etc. is strongly preferred. Familiarity with software such as MATLAB, LabVIEW, Visual Basics, etc. is a plus.
• Candidate should be self-driven with strong analytical and communication (spoken and written) skills to help identify project risks and develop mitigation plans as well as support internal decision making.
• This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.
• Must have demonstrated technical leadership and ownership, and the ability to provide guidance and direction to less experienced technical personnel.
• Travel will be required, as necessary (10%).
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 4 days agoschedule_type: Full-time
Description - External
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world...
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical
Description - External
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world...
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Position Overview:
Business Development Manager represents the Facial Aesthetics product portfolio to targeted aesthetic customers within a designated geographical area. Responsible for creating product acceptance and enhancing portfolio growth through business development activities. The BDM provides technical product and procedure expertise as well as competitive product differentiation. Assigned sales goals are obtained through creative, consultative selling and implementation of the U.S. Sales/Marketing plan. The company offers flexible career paths with a strong emphasis on opportunity for internal mobility.
Main Areas of Responsibilities
The Business Development Manager (BDM) leverages Allergan Medical resources to enhance adoption of the Facial Aesthetics Portfolio. Synergistically works and coordinates activities with other Allergan sales personnel and support teams (include, but are not limited to, facial aesthetics, breast aesthetic, APCs, neurology, topical aesthetics, medical dermatology, marketing, and other Allergan sales forces). Complies with required reports, requests, and compliance policies. Effectively manages field assets and resources to include, but not limited to, expense management, computer and other allocated equipment.
#LI-AA
Education:
• Bachelor’s degree or higher required
Requirements:
• 3 to 5 years successful medical sales/practice management experience
• 7 to 10 years business experience
• Experience and knowledge of general marketing principles and concepts within the healthcare environment
• Experience and knowledge of inner workings of a physicians practice
• Valid driver’s license
Preferred Skills and Qualifications
• Analytical skills
• Strong business acumen
• Proven selling skills
• Strong and effective consultative skills
• Strong conflict and problem resolution skills
• Ability to develop key strategies and execute
• Strong communication skills, both verbal and written
• Strong interpersonal skills
• Strong contract/negotiating skills
• Financial/budgetary experience
• Ability to travel
• Ability to lift 50 lbs.
• Proficiency on excel, word, power point and other software skills
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world...
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Position Overview:
Business Development Manager represents the Facial Aesthetics product portfolio to targeted aesthetic customers within a designated geographical area. Responsible for creating product acceptance and enhancing portfolio growth through business development activities. The BDM provides technical product and procedure expertise as well as competitive product differentiation. Assigned sales goals are obtained through creative, consultative selling and implementation of the U.S. Sales/Marketing plan. The company offers flexible career paths with a strong emphasis on opportunity for internal mobility.
Main Areas of Responsibilities
The Business Development Manager (BDM) leverages Allergan Medical resources to enhance adoption of the Facial Aesthetics Portfolio. Synergistically works and coordinates activities with other Allergan sales personnel and support teams (include, but are not limited to, facial aesthetics, breast aesthetic, APCs, neurology, topical aesthetics, medical dermatology, marketing, and other Allergan sales forces). Complies with required reports, requests, and compliance policies. Effectively manages field assets and resources to include, but not limited to, expense management, computer and other allocated equipment.
#LI-AA
Education:
• Bachelor’s degree or higher required
Requirements:
• 3 to 5 years successful medical sales/practice management experience
• 7 to 10 years business experience
• Experience and knowledge of general marketing principles and concepts within the healthcare environment
• Experience and knowledge of inner workings of a physicians practice
• Valid driver’s license
Preferred Skills and Qualifications
• Analytical skills
• Strong business acumen
• Proven selling skills
• Strong and effective consultative skills
• Strong conflict and problem resolution skills
• Ability to develop key strategies and execute
• Strong communication skills, both verbal and written
• Strong interpersonal skills
• Strong contract/negotiating skills
• Financial/budgetary experience
• Ability to travel
• Ability to lift 50 lbs.
• Proficiency on excel, word, power point and other software skills
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 6 days agoschedule_type: Full-time
Overview:
The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as... bi-specifics and novel modalities, to human clinical studies
Overview:
The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as... bi-specifics and novel modalities, to human clinical studies and eventual licensure.
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Scientist I to join a new team that will be responsible for process analytics. The Process Analytics team’s mission will be to provide enhanced understanding of cell line, upstream, and downstream processes, and to streamline process development decisions and timelines through application of data-rich, high-throughput, rapid-turnaround analytics and automation. In this role, you will report to the lead of the Process Analytics team and be responsible for analytical testing and evaluation of process intermediates to enable cell line, cell culture, and purification development. Additionally, you will be responsible for conceiving, developing, and implementing innovative, fit-for-purpose in-process methods that advance analytical capabilities to enable cell line and process development.
Responsibilities include:
• Conceive and develop innovative, data-rich, high-throughput, and automated in-process analytical methods and workflows to enable and enhance process understanding and process development efficiency.
• Perform analytical testing of process intermediates using multi-attribute methods (MAM), LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and other methodologies and automation.
• Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for cell line development and process development experiments.
• Interpret and communicate in-process analytical results to cross-functional collaborators and stakeholders in a manner that informs cell line selection and process development decisions.
• Collaborate and communicate effectively with Analytical Molecule Leads to provide data and results from in-process testing for consideration in the context of the overall Analytical Development/QC control strategy.
• Engage with analytical subject matter experts to investigate in-process findings that warrant further interrogation with advanced extended characterization methodologies.
• Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
• Serve as a subject matter expert for in-process analytics on cross-functional teams.
• Document laboratory work according to good documentation practices.
• This position is an onsite, lab-based role. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.
Education/Experience:
• Ph.D. in analytical chemistry, chemistry, biochemistry, or related field. MS and BS candidates with minimum of 8 years (MS) or 10 years (BS) of relevant industry experience and strong record of technical achievement and innovation will also be considered.
• Expertise with LCMS peptide mapping for PTM analysis of antibodies, bispecifics, and similar protein therapeutics and mass spectrometry analysis of intact proteins.
• Experience with multi-attribute methods (MAM) and automation pertaining to liquid handling, sample preparation, testing and result reporting is a plus.
• Expertise in applying liquid handling robots and automation for sample cleanup, sample preparation, and analysis is highly desired.
• General understanding of CMC Analytical Development of protein therapeutics is desired.
• Experience in application of analytical methods to process development and general understanding of process steps employed in manufacture of recombinant protein therapeutics is a plus.
• Understanding of therapeutic protein quality attributes, especially in the context of influence of cell line and manufacturing process on such attributes is desired.
• Hands on experience with analytical methods for proteins, including but not limited to HPLC, UPLC, CE, ELISA, Octet, and other binding assay formats.
• Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
• Must have strong communication skills, including verbal, written, and scientific data presentation.
• Must be forward-thinking and able to lead and contribute to scientific/technical discussions.
• Ability to independently learn, understand and execute novel/advanced scientific techniques.
• Ability to author technical reports and presentations.
• Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs.
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, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as... bi-specifics and novel modalities, to human clinical studies and eventual licensure.
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Scientist I to join a new team that will be responsible for process analytics. The Process Analytics team’s mission will be to provide enhanced understanding of cell line, upstream, and downstream processes, and to streamline process development decisions and timelines through application of data-rich, high-throughput, rapid-turnaround analytics and automation. In this role, you will report to the lead of the Process Analytics team and be responsible for analytical testing and evaluation of process intermediates to enable cell line, cell culture, and purification development. Additionally, you will be responsible for conceiving, developing, and implementing innovative, fit-for-purpose in-process methods that advance analytical capabilities to enable cell line and process development.
Responsibilities include:
• Conceive and develop innovative, data-rich, high-throughput, and automated in-process analytical methods and workflows to enable and enhance process understanding and process development efficiency.
• Perform analytical testing of process intermediates using multi-attribute methods (MAM), LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and other methodologies and automation.
• Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for cell line development and process development experiments.
• Interpret and communicate in-process analytical results to cross-functional collaborators and stakeholders in a manner that informs cell line selection and process development decisions.
• Collaborate and communicate effectively with Analytical Molecule Leads to provide data and results from in-process testing for consideration in the context of the overall Analytical Development/QC control strategy.
• Engage with analytical subject matter experts to investigate in-process findings that warrant further interrogation with advanced extended characterization methodologies.
• Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
• Serve as a subject matter expert for in-process analytics on cross-functional teams.
• Document laboratory work according to good documentation practices.
• This position is an onsite, lab-based role. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.
Education/Experience:
• Ph.D. in analytical chemistry, chemistry, biochemistry, or related field. MS and BS candidates with minimum of 8 years (MS) or 10 years (BS) of relevant industry experience and strong record of technical achievement and innovation will also be considered.
• Expertise with LCMS peptide mapping for PTM analysis of antibodies, bispecifics, and similar protein therapeutics and mass spectrometry analysis of intact proteins.
• Experience with multi-attribute methods (MAM) and automation pertaining to liquid handling, sample preparation, testing and result reporting is a plus.
• Expertise in applying liquid handling robots and automation for sample cleanup, sample preparation, and analysis is highly desired.
• General understanding of CMC Analytical Development of protein therapeutics is desired.
• Experience in application of analytical methods to process development and general understanding of process steps employed in manufacture of recombinant protein therapeutics is a plus.
• Understanding of therapeutic protein quality attributes, especially in the context of influence of cell line and manufacturing process on such attributes is desired.
• Hands on experience with analytical methods for proteins, including but not limited to HPLC, UPLC, CE, ELISA, Octet, and other binding assay formats.
• Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
• Must have strong communication skills, including verbal, written, and scientific data presentation.
• Must be forward-thinking and able to lead and contribute to scientific/technical discussions.
• Ability to independently learn, understand and execute novel/advanced scientific techniques.
• Ability to author technical reports and presentations.
• Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs.
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, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 4 days agoschedule_type: Full-time
Purpose:
The Animal Care Technician III provides exemplary animal care and adheres to all department and AbbVie regulatory expectations. Provides animal husbandry and oversight in support of the AbbVie drug discovery and development process...
Responsibilities:
• Mastered the husbandry of all species housed and cared for in the AbbVie animal facilities governed by Lake County. In addition supports the daily operation of the animal facilities through
Purpose:
The Animal Care Technician III provides exemplary animal care and adheres to all department and AbbVie regulatory expectations. Provides animal husbandry and oversight in support of the AbbVie drug discovery and development process...
Responsibilities:
• Mastered the husbandry of all species housed and cared for in the AbbVie animal facilities governed by Lake County. In addition supports the daily operation of the animal facilities through coaching and mentoring junior staff. Assists in the daily coordination of activities in the Vivarium.
• Maintains the vivarium and support areas through proper execution of assigned tasks. Directly performs the daily activities involved with cleaning and spraying cages, disinfecting and sanitizing equipment, and stocking supplies. Follows department procedures, to include but not be limited to: cage cleaning, room sanitation, equipment preparation and moving, and cage changes.
• Physically supports the receiving and quarantine housing of primates.
• Maintains daily husbandry tasks through proper execution of training materials and assigned tasks. Directly performs animal handling, carrying and holding animal cages and animals, using and moving carts, hoses or any other lab equipment and supplies.
• Follows department procedures to provide comprehensive observation and handling of various research animals. Assists with the receiving and housing of research animals; including preparing for the housing activity.
• Assists in the orientation of new employees and the training of lesser experienced staff. Provides basic technical husbandry training to new employees.
• Documents tasks in both written and electronic platforms in accordance with regulatory expectations. Documentation style must be neat, organized, and consistent with departmental standards.
• Maintains area of responsibility by practicing good observation skills and attention to detail. Physical dexterity, visual and auditory acuity, and sensitivity to changes in environmental conditions are utilized in daily task performance.
• Uses experience and training to make decisions to execute daily responsibilities to support animal care operations. Executes hydrogen peroxide cycles as necessary to support facility operations.
• Applies computer skills to maintain regulatory compliance and training to include but not limited to, email, calendar, and computer based training modules. Assists in the development of departmental documentation and training materials.Assures duties are completed accurately not to impact pipeline activities and/or integrity of regulatory expectations.
Education/experience:
• HS education and a minimum of one year experience in a laboratory animal care facility or an Associate’s Degree in a related field.
• Problem-solving ability consisting of taking initiative to handle basic issues autonomously and working with team members for the more complex issues to support animal care operations.
• Ability to safely lift 50 pounds, consistently stand and walk for extended periods of time, to include walking and adhering to safety rules and expectations including but not limited to: grasping, squeezing, pushing, pulling, squatting, stooping, and bending.
• Willing and able to work a rotating schedule which includes some level of mandatory weekend coverage and holiday coverage.
• Ability to work in compliance with all local, federal, AAALAC, and USDA regulations.
• Good communication skills with both internal staff and those external of the department. Ability to maintain efficiency in the workplace and effective in a team environment.
• Attention to detail to provide good animal welfare.
• Able to adhere to appropriate biosafety and biosecurity procedures, including wearing appropriate Personal Protective Equipment
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs.
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, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
The Animal Care Technician III provides exemplary animal care and adheres to all department and AbbVie regulatory expectations. Provides animal husbandry and oversight in support of the AbbVie drug discovery and development process...
Responsibilities:
• Mastered the husbandry of all species housed and cared for in the AbbVie animal facilities governed by Lake County. In addition supports the daily operation of the animal facilities through coaching and mentoring junior staff. Assists in the daily coordination of activities in the Vivarium.
• Maintains the vivarium and support areas through proper execution of assigned tasks. Directly performs the daily activities involved with cleaning and spraying cages, disinfecting and sanitizing equipment, and stocking supplies. Follows department procedures, to include but not be limited to: cage cleaning, room sanitation, equipment preparation and moving, and cage changes.
• Physically supports the receiving and quarantine housing of primates.
• Maintains daily husbandry tasks through proper execution of training materials and assigned tasks. Directly performs animal handling, carrying and holding animal cages and animals, using and moving carts, hoses or any other lab equipment and supplies.
• Follows department procedures to provide comprehensive observation and handling of various research animals. Assists with the receiving and housing of research animals; including preparing for the housing activity.
• Assists in the orientation of new employees and the training of lesser experienced staff. Provides basic technical husbandry training to new employees.
• Documents tasks in both written and electronic platforms in accordance with regulatory expectations. Documentation style must be neat, organized, and consistent with departmental standards.
• Maintains area of responsibility by practicing good observation skills and attention to detail. Physical dexterity, visual and auditory acuity, and sensitivity to changes in environmental conditions are utilized in daily task performance.
• Uses experience and training to make decisions to execute daily responsibilities to support animal care operations. Executes hydrogen peroxide cycles as necessary to support facility operations.
• Applies computer skills to maintain regulatory compliance and training to include but not limited to, email, calendar, and computer based training modules. Assists in the development of departmental documentation and training materials.Assures duties are completed accurately not to impact pipeline activities and/or integrity of regulatory expectations.
Education/experience:
• HS education and a minimum of one year experience in a laboratory animal care facility or an Associate’s Degree in a related field.
• Problem-solving ability consisting of taking initiative to handle basic issues autonomously and working with team members for the more complex issues to support animal care operations.
• Ability to safely lift 50 pounds, consistently stand and walk for extended periods of time, to include walking and adhering to safety rules and expectations including but not limited to: grasping, squeezing, pushing, pulling, squatting, stooping, and bending.
• Willing and able to work a rotating schedule which includes some level of mandatory weekend coverage and holiday coverage.
• Ability to work in compliance with all local, federal, AAALAC, and USDA regulations.
• Good communication skills with both internal staff and those external of the department. Ability to maintain efficiency in the workplace and effective in a team environment.
• Attention to detail to provide good animal welfare.
• Able to adhere to appropriate biosafety and biosecurity procedures, including wearing appropriate Personal Protective Equipment
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs.
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, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 6 days agoschedule_type: Full-time
• External expert (opinion leader) cultivation: Identifies, gains access to, and develops professional relationships with external experts in therapeutic areas of interest within assigned geography.
• Provides education relative to disease state and AbbVie products across the product lifecycle to healthcare providers and researchers.
• Serves as a medical/scientific resource to healthcare... providers through answering unsolicited medical questions,
• External expert (opinion leader) cultivation: Identifies, gains access to, and develops professional relationships with external experts in therapeutic areas of interest within assigned geography.
• Provides education relative to disease state and AbbVie products across the product lifecycle to healthcare providers and researchers.
• Serves as a medical/scientific resource to healthcare... providers through answering unsolicited medical questions, and addressing other clinically related medical information issues.
• Clinical trial support: Supports research initiatives across development at the request of R&D to include but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and study management.
• Project management: Works with internal Medical Affairs customers to develop and execute a territory plan designed to support and meet shared business objectives.
• Inputs and maintains internal database as it relates to activities in their geography.
• Prepares marketplace in new therapeutic areas of interest, which includes creating awareness and relationships for AbbVie in the Medical community.
• Serves as a scientific resource to commercial partners, as appropriate, to support activities
• Self-development: Develops and communicates a professional growth plan. Continually educates self on global market issues, trends, and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.
• Takes responsibility for and actively manages professional development.
• Advanced degree required (i.e. Pharm D, MD/DO, PhD, PA or NP, BSN) in a relevant scientific discipline. Doctorate strongly preferred in a health science or clinical discipline. Significant industry experience in relevant therapeutic area may be accepted in lieu of education requirements.
• Greater than or equal to 2 years as a Medical Science Liaison required.
• At least 3 years of clinical, scientific research or industry related experience or equivalent required.
• Previous pharmaceutical industry experience within relevant scientific discipline preferred.
• Ability to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
• The Senior Medical Science Liaison must be able to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
• An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
• Provides education relative to disease state and AbbVie products across the product lifecycle to healthcare providers and researchers.
• Serves as a medical/scientific resource to healthcare... providers through answering unsolicited medical questions, and addressing other clinically related medical information issues.
• Clinical trial support: Supports research initiatives across development at the request of R&D to include but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and study management.
• Project management: Works with internal Medical Affairs customers to develop and execute a territory plan designed to support and meet shared business objectives.
• Inputs and maintains internal database as it relates to activities in their geography.
• Prepares marketplace in new therapeutic areas of interest, which includes creating awareness and relationships for AbbVie in the Medical community.
• Serves as a scientific resource to commercial partners, as appropriate, to support activities
• Self-development: Develops and communicates a professional growth plan. Continually educates self on global market issues, trends, and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.
• Takes responsibility for and actively manages professional development.
• Advanced degree required (i.e. Pharm D, MD/DO, PhD, PA or NP, BSN) in a relevant scientific discipline. Doctorate strongly preferred in a health science or clinical discipline. Significant industry experience in relevant therapeutic area may be accepted in lieu of education requirements.
• Greater than or equal to 2 years as a Medical Science Liaison required.
• At least 3 years of clinical, scientific research or industry related experience or equivalent required.
• Previous pharmaceutical industry experience within relevant scientific discipline preferred.
• Ability to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
• The Senior Medical Science Liaison must be able to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
• An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
via AbbVie Careers
posted_at: 6 days agoschedule_type: Full-time
The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.
Responsibilities...
• Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project
The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.
Responsibilities...
• Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.
• Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review protocols, statistical analysis plans, and statistical programing plans.
• Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Represent DSS on data monitoring committees. Build interdepartmental relationships.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
• Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
• Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department
• Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Represent DSS in discussions with regulatory agencies and on Advisory Committees.
• Develop an external presence within the statistics community and represent AbbVie on advanced and emerging topics.
• MS (with 14+ years of experience) or PhD (with 10+ years of experience) in Statistics, Biostatistics, or a highly related field.
• High degree of technical competence and excellent communication skills, both oral and written
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from other
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
• Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
• Pharmaceutical industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
• Prior experience in Immunology is preferred
• For people mangers, prior experience of people management is required
Key Stakeholders
· Clinical development experts
· Statistical programmers
· Data science experts
· Global Medical Affairs experts
· Regulatory experts
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
Responsibilities...
• Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.
• Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review protocols, statistical analysis plans, and statistical programing plans.
• Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Represent DSS on data monitoring committees. Build interdepartmental relationships.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
• Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
• Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department
• Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Represent DSS in discussions with regulatory agencies and on Advisory Committees.
• Develop an external presence within the statistics community and represent AbbVie on advanced and emerging topics.
• MS (with 14+ years of experience) or PhD (with 10+ years of experience) in Statistics, Biostatistics, or a highly related field.
• High degree of technical competence and excellent communication skills, both oral and written
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from other
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
• Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
• Pharmaceutical industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
• Prior experience in Immunology is preferred
• For people mangers, prior experience of people management is required
Key Stakeholders
· Clinical development experts
· Statistical programmers
· Data science experts
· Global Medical Affairs experts
· Regulatory experts
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours Show more details...
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