Medical Director Camcar
hace 7 días
**OBJECTIVE**
Manage and lead the Medical Affairs team ensuring full medical-scientific and nominated signatory support to all processes and areas of the organization, so as to achieve scientific leadership and contribution to the fulfillment of the Company's BSC.
Responsible for strategic medical direction, ensuring the development of medical competencies in accordance with the corporation's standards, resource planning and execution, as well as the development of the members of his/her area.
Responsible for Regulatory Affairs and Quality, scientific and strategic aspects of the portfolio products, including strategic responsibilities for Medical Affairs, Patient Safety, Market Access, Corporate Affairs and External Affairs. In addition, he performs Compliance support functions as a Nominated Signatory.
**RESPONSABILITIES**
- Management of the Medical Affairs area at the Company.
- Responsible for the role of Chief Nominated Signatory.
- Contribute to establishing the Company's vision and direction for the development of the organization in accordance with global, GMD policies and strategies of the International Region and Area
- Ensure the implementation of strategic initiatives within the regulatory, legal and Compliance framework.
- Propose, execute and control the budget of the area, guaranteeing optimal use of resources.
- Responsible for supporting the development of evidence generation within the Marketing Company, including real world evidence and pharmaco-economic analysis of portfolio products, as well as liasing with above-country responsibles of evidence generation initiative to support participation in global or regional projects if feasible.
- Ensure synergies of work between the Medical Affairs and MS&M (ClinOps) teams to optimize the results of local implementation of global clinical trials.
- Ensure the development of a succession plan for the Medical director role, through the corresponding development of competencies in the team.
- Ensure that business critical positions within Medical Affairs have an appropriate succession plan.
- Attract, hire, develop and retain the best talent.
- Evaluate the performance of the area and implement improvement initiatives.
- Ensure the construction of a network of high reputation and scientific leadership relationships with key opinion leaders and the relevant medical and scientific community in the country.
- Positively represent AZ before the guild, government forums, medical symposiums and advisory boards to enrich AZ's medical image and reputation.
- Ensure organization tables, work descriptions, resumes, and training records are up to date and available to staff in the area.
- As a member of the SMT, contribute extensively in decision-making in the face of local market circumstances and brand strategies.
- Ensure that internal and external medical information and management of publications in accordance with relevant standards and policies.
- Work cross-functionally with Market Access to strengthen institutional working alliances and the presence of AZ portfolio products in them.
- Responsible for approving the procedures (SOPs) of the medical area, in order to ensure their maintenance and updating throughout the year.
- Responsible for identifying the risks associated with the medical area that affect the fulfillment of business objectives each year:
- Identify risks at the beginning of the year.
- Establish an action plan, date of implementation of improvement plan and responsible for each risk.
- Update risk and action plan according to changes in the environment and business.
- Present to the Compliance Committee the progress of the risk action plans associated with the department.
- Comply with the proposed actions for risk mitigation.
- Responsible for continuous monitoring of the activities associated with the Medical Area, in order to ensure compliance with corporate policies, codes and procedures.
- Responsible for complying with AstraZeneca's Code of Conduct, Corporate/Local Policies, Standards, Procedures, Regulations and Other Guidelines, by Members of the Medical Area and for reporting any breach thereof.
GXP
- Approve local procedures associated with your area
- Ensure the training of your team in the corporate GxP and local regulatory requirements applicable to the role they perform
- Identify and report any complaints, deviations and/or adverse events that you are aware of within the established time
- Provide support and recommendations during quality research including audit and reporting processes
- Participate in regular GxP reviews to identify risks and deviations and develop the corresponding actions to ensure GxP compliance
- Ensure adequate allocation of resources for the appropriate performance of all GMP/GDP/GRP/GVP/GCP
- Know and meet the GxP requirements associated with your charge
SHE
- Support and contribute to the fulfilment of the objectives of the SHE Occupational Safety and Health Management System to encou
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