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Re: ChrisMissing post# 357124

Tuesday, 04/12/2022 2:35:49 PM

Tuesday, April 12, 2022 2:35:49 PM

Post# of 458278
Blarcasamine

[In speaking with a friend of mine who is in the biotech world he told me this is the most important of positions that were listed on their website. A key responsibility of this person is to provide insurance companies with the necessary comparisons of our products vs the competitor products (SOC). Overall a very important job.

Thanks very much for your high value added note : I would also emphasize w/my bolded We might also agree on the high skill shown by the text choice of language and emphasis. Who ever wrote this knows what they are doing. IMO.

Senior/Executive Director, Clinical Development and Medical Evidence

Key Responsibilities
Provide integrated epidemiology expertise through contributions to preclinical programs, clinical development, post-approval studies, and commercialization activities.

Support clinical and safety objectives of development programs, and work with commercial teams to maximize the potential of Anavex products and ensure support for appropriate target claims and messages.

Lead the design and execution and provide oversight for delivery and effective communication of high-quality epidemiology/RWE studies to support internal and external decision making, and to deliver clinical development programs.

Responsible for developing the epidemiology/RWE sections of regulatory documents and submissions including RMPs, breakthrough or orphan designations.

Support abstract and manuscript preparation for dissemination including for scientific communication, regulatory submissions, and payor dossiers and value packs.

Provide guidance and direction to project teams, leaders, and other co-workers to ensure efficient management of project opportunities and potential risks at all stages of pharmaceutical development.

Maintain oversight of RWE/RWD studies including negotiating appropriate timeframes and appropriate delivery of agreed study goals and effective presentation of results.

Participate in development of new processes, SOPs, trainings, and working documents relevant for the implementation of Epidemiology/RWE./quote]

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