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The Patient Reported Outcomes Specialist will set and lead PRO strategies and direct delivery of such plans to ensure high quality evidence supporting products' regulatory approval, reimbursement and commercialisation.
The successful candidate will be responsible for driving high quality evidence claims by working with assigned therapeutic areas across the development cycle to:
* Determine and deliver guidance on which disease/therapy areas and early projects will need a PRO as a clinical endpoint;
* Investigate to what extent PRO and Clinical Outcome Assessment (COA) endpoints are developed, fit-for-purpose and approved by Regulatory Authorities and also how well they will meet the organisations project needs, to provide the most appropriate PRO strategic recommendation;
* Ensure, when relevant, that new instruments are developed and fit-for-purpose;
* Provide PRO and COA strategic advice on the planning, use and promotion of new or existing instruments for the organisations products to ensure consistency, coordination and quality within and across projects.
The PRO specialist will interact with regulatory authorities and key opinion leaders, as well as with relevant the organisations cross-functional teams (eg, CPTs, DIWGs, Payer Teams), to provide PRO related leadership to assigned projects, and will be accountable for TA PRO standards, the input to dTPPs/TPPs/TPC and clinical plans developed in the DIWG. The role holder will ensure that fit-for-purpose PRO recommendations and documentation have been completed and assembled for PRO dossier discussions and submissions.
To be successful, applicants must have relevant experience of PRO scientific work, preferably quantitative as well as qualitative (including work within the pharmaceutical industry or related). In addition candidates must have previous project management or personnel management preferred and significant previous project leadership experience in the generation of PRO evidence and strategic work
On offer is a competitive salary plus benefits and the opportunity to develop your career within a leading global pharmaceutical organisation.For further information and a detailed job specification please contact Immanuel Ross at Real Staffing.com on 0207 758 7311 or send an email
To find out more about Real Staffing please visit www.realstaffing.com