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Posted date: Mar. 20, 2019
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 inspired by the things that seem impossible. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them.
To lead, from a scientific /strategic perspective, the planning and execution of AstraZeneca-sponsored evidence generation studies and the review and support of Externally Sponsored Scientific Research studies (ESR), as well as the setup of Early Access Programs (EAP) and Foreign Medication programs (FMP) and their associated publications, within agreed time, budget (cost and resources) and quality, to increase patient’s quality of life.
• To provide methodological leadership and innovative thinking regarding the design of evidence generation studies
• To participate in Brand Teams; to lead strategic definition of medical evidence generation needs per product / disease / area and preparation of evidence plans.
• To support and advise External investigators in their preparation of ESR proposals.
• To participate in GREG and MEORT meetings to defend ESR and local AZ-sponsored study proposals, respectively.
• To cooperate closely with GMA and Europe Region for the conduct of evidence generation studies.
• To work actively towards achieving good personal relationships with applicable internal stakeholders such as Medical Managers, Medical Leads, Medical Director, MedEx, Pharmacovigilance, Compliance, Market Access, Quality, GMA, GREG and Global Publications teams.
• To work actively towards achieving good personal relationships with external key stakeholders such as principal investigators of AstraZeneca-sponsored or externally- sponsored evidence generation studies, to ensure their scientific robustness and strategic alignment.
• To work in close collaboration with the support team at MEDICLIN, ensuring a fluent and open communication during the whole governance process.
• To contribute to the planning of Evidence Generation programs with the Therapeutic Areas, GMA and Europe Region, from a scientific / strategic perspective.
• To act as the person of reference for all matters related to evidence generation studies assigned to them.
• To develop or adapt SDCs, protocols, informed consents, reports and other study documents or their amendments (or their review for ESRs), following AZ regulations.
• To collaborate with local MSLs in evidence generation study support.
• To coordinate all matters related to publications derived from evidence generation studies: authoring (when appropriate), accuracy (review of the data against source documents), consistency between sections, contribution to the preparation of the local publication plan included in the Medical Plans, keeping track of relevant congress deadlines, coordination of the publication approval process (local and global). In the case of ESRs, to discuss AZ reviewers’ comments with investigators / authors.
• To contribute to set-up of Early Access Programs (EAP) and Foreign Medication programs (FMP), defining appropriate tracking tools, workflow and distribution of responsibilities between different stakeholders.
• To ensure that all job-related activities comply with relevant applicable AZ Procedural Documents, international guidelines such as ICH/GCP and relevant local legislation.
• To ensure that evidence generation studies meet quality standards, follow internal SOPs for AZ-sponsored and ESR studies, are scientifically robust, consistent with the company strategy, and adhere to agreed timelines and productivity targets, including:
o Forecast and day-to-day management of study timelines.
o Ensuring that studies are registered in the appropriate systems (Evidence Connect, ESROS, InvestigAZ) and these are used and kept up to date.
o Planning and co-leading National Investigator meetings following local codes, as required.
• To ensure compliance with AZ Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• To act as the reference person for AZ-sponsored or ESR studies in case of local audits and regulatory inspections, in cooperation with QA and Medical Affairs teams.
Minimum Requirements – Education and Experience
• University degree in biological science or healthcare-related field.
• Excellent knowledge of spoken and written English (C1).
• Minimum 3 years of experience (not just operational) in Medical Affairs-led studies, Academic-led clinical studies or Epidemiological studies.
• Knowledge of the pharmal industry and especially of Medical Affairs departments and their responsibilities.
• Excellent project management skills, including budgetary and resource planning.
• Very good knowledge of clinical study and drug development processes, GCP/ICH guidelines and local applicable regulations.
• Appropriate understanding of at least 2 therapeutic areas or 2 main indications within one therapeutic area including familiarity with the latest research and KOL.
• Experience in studies of at least two phases (phase I-IV) of clinical development, or at least two types of study designs (e.g. interventional, non-interventional, prospective, retrospective, with databases).
• Proven ability to lead and motivate cross-functional teams to deliver evidence generation studies according to or ahead of time plan, budget and with required quality
• Excellent team building and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent organisational skills.
• Excellent attention to details.
• Good ability to learn and to adapt to work with IT systems.
• Open to periods of traveling, including national and international trips.
• Good understanding of the Drug Development Process.
• Good decision making and delegation skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.
• Good intercultural awareness.
• Good analytical skills.
• Good negotiation skills.
4. FUNCTIONAL RELATIONSHIPS
• Spain Medical Director and Therapeutic Area Leads.
• Line manager (Medical Evidence Generation Lead)
• Spain Medical Managers and Medical Scientific Liaisons.
• Market Access Managers.
• QA, Pharmacovigilance, MedEx, Nominated Signatory and Compliance teams.
• MEORT, GREG and publications teams.
• Spain MC Clinical Research representatives: Clinical Research Head, monitors (Sr CRAs, CRAs) and SDAs
• Clinical Research Leadership team.
• Regulatory Affairs Managers.
• Principal Investigators of AstraZeneca-sponsored evidence generation studies and ESR´s.
• Investigators and Study Site personnel as per need.
• IEC, IRBs
• CRO´s and other vendors.
- Communication with impact
- Cross-functional Collaboration
- Stakeholder engagement
Medical standards & quality:Compliance
- Managing Performance
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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