Associate Scientific Director, Rheumatology, International Medical Affairs

The Associate Director provides medical and scientific strategic and operational input into core medical affairs activities including but not limited to: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); internal and external educational initiatives (medical education, scientific communications, training, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). This position works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. Develops and maintains professional and credible relationships with key opinion leaders. Leads and coordinates appropriate internal facing scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory etc) including but not limited to evidence gap workshops, scientific platform and narrative, external expert engagement mapping, medical education projects, and planning ahead of key scientific meetings/congresses aligned to the Medical Functional Plan. Provides scientific/medical education to investigators, clinical monitors, and Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy Leadership of external Medical Affairs activities such as, but not limited to, advisory boards, congress support, medical education programs, training and symposia. Assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of medical affairs sponsored or supported clinical research activities. Ensures budgets, timelines, compliance requirements are factored into medical affairs programs and scientific activities. Participation in the design, analyses, interpretation, and reporting of scientific content related to protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. Participates in the design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements