The Senior Manager Patient Inclusion sits within the Clinical Development Operations (CDO) organisation at AbbVie and is responsible for supporting the strategic and tactical implementation of AbbVies enterprise-wide plan to improve clinical trial inclusion. By understanding the unique barriers and needs of patients you will be an important member of the team that will be driving change in the internal culture behaviours and ways of working to strengthen our understanding of disease disparities and the effects on global clinical trial populations.
KEY DUTIES AND RESPONSIBILITIES
- Align with the Director to enhance the roadmap and develop the action plan to implement AbbVies Patient Inclusion strategy across the portfolio
- Collaborate with cross-functional partners to identify process improvements to disease area strategies and clinical trial lifecycle to increase representative patient participation
- Partner with regionally aligned counterparts in Patient Inclusion to develop a strategy to scale current patient inclusion framework to indication level plans that incorporate global considerations
- Identify relevant data sources that synthesise clinical epidemiological and real-world evidence on disease prevalence incidence burden and health disparities and extract meaningful data to support global patient access strategies.
- Work in-region to support global expansion of Patient Inclusion capabilities and processes
- Influence leaders to champion internal behaviours to strengthen our understanding of disease disparities and the effects of representative populations
- Work with key stakeholders to develop TA/indication level strategies to increase representation in clinical trials
- Maximise external engagement by leveraging existing relationships and exploring new opportunities to collaborate with community partners patient advocate organisations institutions and key Health Care Practitioners to broaden knowledge about clinical research in underrepresented communities and support the patient care journey.
- Reinforce alignment between the Patient Inclusion principles and AbbVies business strategy
- Monitor impact of Patient Inclusion strategies based on analytics to demonstrate improvement in trial representation
- Report any adverse event within 24 hours as per AbbVies policies and procedures.
- Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVies internal codes of conduct and compliance processes.
- Other ad hoc duties such as administrative duties as requested.
Qualifications :
- Bachelors Degree in a scientific field required Advanced degree is desirable.
- Minimum of 8 years of pharma-related/clinical research experience or equivalent
- 6 years of patient recruitment project management and people management (preferred)
- Advanced working knowledge of ICH and GCP guidelines required.
- Operational understanding of the global regulatory environment is desirable.
- Strong proficiency in authoring and reviewing scientific medical and regulatory documents to ensure consistency and strategic alignment with global submissions
- Skilled in managing the end-to-end development of regulatory-ready submission documents
- Excellent collaborator and articulate communicator
- Strategic thinker with understanding of clinical development process and uses data to drive the business and continuous improvements.
Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information :
WAYS WE WORK
- All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
- Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
- Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
- Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
- Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
- AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers.
- AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws.
- All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
- AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
The Senior Manager Patient Inclusion sits within the Clinical Development Operations (CDO) organisation at AbbVie and is responsible for supporting the strategic and tactical implementation of AbbVies enterprise-wide plan to improve clinical trial inclusion. By understanding the unique barriers and ...
The Senior Manager Patient Inclusion sits within the Clinical Development Operations (CDO) organisation at AbbVie and is responsible for supporting the strategic and tactical implementation of AbbVies enterprise-wide plan to improve clinical trial inclusion. By understanding the unique barriers and needs of patients you will be an important member of the team that will be driving change in the internal culture behaviours and ways of working to strengthen our understanding of disease disparities and the effects on global clinical trial populations.
KEY DUTIES AND RESPONSIBILITIES
- Align with the Director to enhance the roadmap and develop the action plan to implement AbbVies Patient Inclusion strategy across the portfolio
- Collaborate with cross-functional partners to identify process improvements to disease area strategies and clinical trial lifecycle to increase representative patient participation
- Partner with regionally aligned counterparts in Patient Inclusion to develop a strategy to scale current patient inclusion framework to indication level plans that incorporate global considerations
- Identify relevant data sources that synthesise clinical epidemiological and real-world evidence on disease prevalence incidence burden and health disparities and extract meaningful data to support global patient access strategies.
- Work in-region to support global expansion of Patient Inclusion capabilities and processes
- Influence leaders to champion internal behaviours to strengthen our understanding of disease disparities and the effects of representative populations
- Work with key stakeholders to develop TA/indication level strategies to increase representation in clinical trials
- Maximise external engagement by leveraging existing relationships and exploring new opportunities to collaborate with community partners patient advocate organisations institutions and key Health Care Practitioners to broaden knowledge about clinical research in underrepresented communities and support the patient care journey.
- Reinforce alignment between the Patient Inclusion principles and AbbVies business strategy
- Monitor impact of Patient Inclusion strategies based on analytics to demonstrate improvement in trial representation
- Report any adverse event within 24 hours as per AbbVies policies and procedures.
- Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVies internal codes of conduct and compliance processes.
- Other ad hoc duties such as administrative duties as requested.
Qualifications :
- Bachelors Degree in a scientific field required Advanced degree is desirable.
- Minimum of 8 years of pharma-related/clinical research experience or equivalent
- 6 years of patient recruitment project management and people management (preferred)
- Advanced working knowledge of ICH and GCP guidelines required.
- Operational understanding of the global regulatory environment is desirable.
- Strong proficiency in authoring and reviewing scientific medical and regulatory documents to ensure consistency and strategic alignment with global submissions
- Skilled in managing the end-to-end development of regulatory-ready submission documents
- Excellent collaborator and articulate communicator
- Strategic thinker with understanding of clinical development process and uses data to drive the business and continuous improvements.
Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information :
WAYS WE WORK
- All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
- Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
- Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
- Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
- Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
- AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers.
- AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws.
- All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
- AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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