BioPharmaceuticals Medical Evidence - Mississauga, Canada - EightSix Network Inc

Description

BioPharmaceuticals Medical Evidence - Evidence Delivery Director Part Time / Full Time

BioPharmaceuticals Medical Evidence - Evidence Delivery Director At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and support our internal stakeholders with medical insight and expertise.

The Evidence Delivery Director (EDD) will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs. The EDD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).

Study Design Concept (SDC) Input:

• Provide insights on operational feasibility during SDC development.
• Coordinate protocol development with internal and external partners.

Study Governance Management:

• Coordinate internal study governance processes.
• Manage study-specific issues and customer concerns with external service providers (ESPs)/CROs.

Partner Management:

• Set up study team and manage study sourcing.
• Collaborate effectively with scientific/medical counterparts and internal cross-functional teams.
• Ensure appropriate involvement of external scientific community during study design and delivery.

Study Finance Management:

• Develop and maintain study budget.
• Manage contracts, POs, and invoices.
• Ensure financial audit readiness and Sox attestation.

Other Project Management Activities:

• Deliver studies within agreed timelines and budget.
• Ensure compliance with procedural documents, standards, policies, and regulations.
• Undertake feasibility assessments and manage study system reporting.

Externally Sponsored Scientific Research (ESR):

Governance:

• Lead review and evaluation of ESR proposals and protocols.
• Ensure operational compliance with ESR policies and procedures globally.

Delivery:

• Manage cross-functional partners to meet AZ obligations for ESR.
• Lead ESR portfolio financial forecasting and budgeting.
• Provide oversight to local Marketing Companies (MC's) for ESR delivery.

Early Access (EA) /Named Patient Supplies (NPS):

EA Program Management:

• Lead planning, implementation, and delivery of EA programs.
• Collaborate with vendors to ensure effective program operations.
• Manage resolution of program-specific issues and partner concerns.

NPS Request Review:

• Manage the review process of NPS requests to ensure timely decision-making.

Typical Accountabilities

Independent of the study type, key accountabilities in the remit of the Evidence Delivery Director are:

Management of study Governance processes

Management of cross-functional internal and external partners

Finance Management

Overall Project Management to deliver according to cost, time and quality

Risk Management, Quality Management

Study compliance

Team Leadership and team resource management

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Are you interested in working at AZ, apply today

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted

23-Feb-2024 Workday Be the first to review Mississauga, ON BioPharmaceuticals Medical Evidence - Evidence Delivery Director Part Time / Full Time BioPharmaceuticals Medical Evidence - Evidence Delivery Director Mississauga, ON (view on map ) Posted 7 days ago

calendar_today Immediate Start Job Description At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and support our internal stakeholders with medical insight and expertise.

The Evidence Delivery Director (EDD) will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs. The EDD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).

• Study Design Concept (SDC) Input:
  • Provide insights on operational feasibility during SDC development.
  • Coordinate protocol development with internal and external partners.
• Study Governance Management:
  • Coordinate internal study governance processes.
  • Manage study-specific issues and customer concerns with external service providers (ESPs)/CROs.
• Partner Management:
  • Set up study team and manage study sourcing.
  • Collaborate effectively with scientific/medical counterparts and internal cross-functional teams.
  • Ensure appropriate involvement of external scientific community during study design and delivery.
• Study Finance Management:
  • Develop and maintain study budget.
  • Manage contracts, POs, and invoices.
  • Ensure financial audit readiness and Sox attestation.
• Other Project Management Activities:
  • Deliver studies within agreed timelines and budget.
  • Ensure compliance with procedural documents, standards, policies, and regulations.
  • Undertake feasibility assessments and manage study system reporting.

Externally Sponsored Scientific Research (ESR):

• Governance:
  • Lead review and evaluation of ESR proposals and protocols.
  • Ensure operational compliance with ESR policies and procedures globally.
• Delivery:
  • Manage cross-functional partners to meet AZ obligations for ESR.
  • Lead ESR portfolio financial forecasting and budgeting.
  • Provide oversight to local Marketing Companies (MC's) for ESR delivery.

Early Access (EA) /Named Patient Supplies (NPS):

• EA Program Management:
  • Lead planning, implementation, and delivery of EA programs.
  • Collaborate with vendors to ensure effective program operations.
  • Manage resolution of program-specific issues and partner concerns.
• NPS Request Review:
  • Manage the review process of NPS requests to ensure timely decision-making.

Typical Accountabilities

Independent of the study type, key accountabilities in the remit of the Evidence Delivery Director are:

• Management of study Governance processes
• Management of cross-functional internal and external partners . click apply for full job details