Клинические исследования
  • Medical Affairs Manager   ( 1 Материал )

    Сведения о компании:

    Представительство крупной западной компании-производителя медицинского оборудования и расходных материалов

     

    Medical Affairs Manager

    Key Responsibilities:

    • Engage identified HCPs and KOLs to demonstrate the clinical outcome and benefits of company products, technologies and therapies; to exchange clinical, safety and comparative-effectiveness information; to explore clinical areas of need and to discuss corporate initiatives.
    • Develop relationships with HCPs and field personnel through scheduled meetings and other interactions. Make clinical presentations and high level pipeline presentations in key targeted accounts. Collaborate closely with Strategic Relations group to develop and execute KOL programs.
    • Participate in the process of identifying and selecting research projects. Develop a network of relationships with research leaders in EMEA through personal visits and interactions at scientific meetings.
    • Collaborate with Clinical department and EMEA marketing groups to build and execute clinical plans to support indication requirements and messaging for Company products.
    • Drive / contribute to content for EMEA specific clinical messaging and educational programs.
    • Responsible for good understanding of submitted concepts and proposals during the ISR review process to ensure that the scientific idea fits into the Company strategy.
    • Communicate with the investigator on all questions prior, during and after the review process.
    • After given approval, help in the contracting and budgeting process to assure correct, reasonable and clear milestones, full understanding of responsibilities and obligations as well as a smooth and timely contracting process.
    • Responsible for ensuring that project studies are well associated with obligatory regulatory processes, supporting procedures.
    • During the conduct of the project, stay in close contact with investigators, arranging technical help in relation to Company products if necessary, help to monitor the progress of the project in order to provide clear project status during quarterly reviews to the committee.
    • Inform relevant Company departments (e.g. R&D, Clinical, Marketing, Health Economics, local affiliates, etc.) who may benefit from results or publications from the supported project. An early link to these departments will also assure to define and track the right milestones for quarterly and annual reports.
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    Quality System Requirements

    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

    For those individuals that supervise others, the following statements are applicable:

     
     
    • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Company Quality Policy.
    • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

    Position Requirements

    Knowledge & Experience:

    • Degree in Life Sciences (or equivalent relevant qualification).
    • Specialised knowledge of clinical issues associated with division.
    • Thorough knowledge of clinical research, device/drug development process, regulatory requirements, laws and good clinical practices.
    • Experience in running clinical trials advantageous.
    • Demonstrated ability to develop and maintain relationships with Key Opinion Leaders.
    • Demonstrated strength in developing and delivering strong, storytelling presentations.
    • Proven ability to communicate complex data to diverse audience.
    • Demonstrated success in managing projects; particularly clinical research programmes.
    • Fluent in English.
    • Willing and able to travel as required by workload (50%).