Study Responsible Physician

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The Study Responsible Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program. The Study Responsible Physician provides an active medical and scientific contributions to a cross-functional clinical team. The Study Responsible Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business-related disciplines. The Study Responsible Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area. ESSENTIAL FUNCTIONS: Participates in the preparation of clinical development plans, trial protocols, has direct responsibility for trial set up and monitoring, and takes responsibility for completion of clinical study reports Evaluates adverse events for the relationship to treatment and is responsible for medical monitoring. Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting May act as a medical contact at the company for health authorities concerning clinical/medical issues Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions Close interactions with Project Scientists and Physicians across programs OTHER RESPONSIBILITIES / DETAILED DUTIES: Assists Regulatory Affairs in the development of drug regulatory strategies Support general Clinical/Medical Affairs activities involving product evaluation, labeling, and surveillance Reviews medical literature and related new technologies May be asked to assess medical publications emerging from the Team and its affiliates This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. PRINCIPAL RELATIONSHIPS: Contacts Inside the Company: Members of the Clinical and Compound Development Teams, including project planning, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology, and other scientific and business-related disciplines Staff from departments of business development, strategic marketing, legal, and the Global Service Organizations, therapeutic area, and franchise Contacts Outside the Company: May act, in concert with senior clinical personnel, as a company spokesperson regarding the publication of clinical research findings and presentations to relevant Health Authority advisory committees and review meetings (e.g. global health authority meeting related to NDA/MAA/BLA). May be asked to assess external clinical research proposals involving Company products relevant to the company’s mission The Study Responsible Physician acts, in concert with medical staff, as a liaison between the company and clinical investigators The Study Responsible Physician develops, in concert with senior clinical staff, credible relationships with scientific leaders, medical directors, and key regulatory officials Supervision: Clinical Franchise Leader, Medical Leader, or other as appropriate Qualifications SUPPLEMENTAL INFORMATION Education: MD (or equivalent) in relevant area with appropriate post-doctoral training and certification Required Technical Knowledge and Skills: Fluent in written and spoken English Working knowledge of the use of Microsoft suite of software products including Excel and Word Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings Primary Location Belgium-Antwerp-Beerse- Organization Janssen Cilag N.V./S.A. (7025) Job Function R&D Requisition ID 2105912911W