Patient Reported Outcomes Director
AstraZeneca / Apotekarjobb / Göteborg
2018-11-09
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hela Sverige Patient Reported Outcomes Director Job Description
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Patient Reported Outcomes Director, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
The Patient Reported Outcomes Director will set and lead TA-level (and underlying project-level) PRO and Patient experience strategies and direct delivery of such plans to ensure high quality evidence supporting products' regulatory approval, reimbursement and commercialization.
Accountabilities/Responsibilities
* Deliver robust TA and project PRO regulatory recommendations globally to meet regulatory, payer and patient needs
* Deliver expert input on PRO needs to TPPs, TPCs and secure PRO dossier and briefing document evidence within the clinical plans and regulatory submissions
* Increase PRO knowledge and effectiveness to drive sustainable patient-centered approaches and PRO input to the drug development value chain.
* Develop relationships with appropriate AZ teams as well as with KEEs and collaborative groups (within the relevant disease area) to enhance AZ's reputation of PRO measurement in the external scientific/regulatory community
* Interact with cross-functional team members at a project level
* Supports GPT and CPT in the design
* Management responsibilities for applicable vendors within or in adjacent projects (e.g. budget planning and record keeping, contract management) in collaboration with procurement
* Supervise vendors and/or study team personnel and associates in PRO/COA instrument development and/or administration.
* Prepares vendor proposal requests for PRO/COA work projects
* Budgeting responsibility for assigned subprojects within the development projects
* Responsible for project management in collaboration with academic researchers and clinical research organizations to time, budget, and quality. Participates in preparation for investigator meetings including work materials & presentations
* Prepares technical presentations
* Prepares PRO/COA data as background materials and registration pack for discussion with regulatory authorities.
* Interaction with regulatory personnel and HTA authorities to prepare background materials; instrument development and validation research for consideration by eg, NICE, EMA, FDA
Minimum Requirements -Education and Experience
* Bachelor's degree in clinical, biological, or social sciences
* Master's degree in relevant field
* Doctoral degree in relevant field preferred
* Minimum of 5 years' experience in the biopharmaceutical industry
* Relevant experience of PRO scientific work
* Excellent knowledge in clinical development and research study designs and interpretation.
* Good understanding of qualitative and quantitative analyses applicable to patient insights, feeling and functioning
* Effectiveness in a scientific advisory role involving both strategic and tactical elements
* Knowledge of AZ's prioritized disease and therapeutic areas
* Experience in partnering and collaborating with external vendors/agencies
* Open to periods of extensive travel
Skills and Capabilities
* Expert knowledge of PRO/COA to pharmaceutical development at an international level
* Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages.
* Knowledge of international healthcare systems and their changing needs for PRO/COA information
* Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims
* Provide innovative scientific knowledge and leadership in patient centered evidence work teams
* Leadership skills and problem-solving capability
* Well-developed conceptual thinking with capability to access internal and external resources for advice
* Proactive application of therapeutic area and disease treatment knowledge.
* Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
* Excellent written and verbal communication skills
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-11-09ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-11-28
Ange följande referens när du ansöker: R-038887
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4449158
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