SCIENTIFIC MEDICAL ADVISOR (OBS&GYN)

Exeltis is an organization that develops innovative treatments and targets the unmet medical needs of individuals, families and healthcare professionals. It has nearly 4,000 professionals in over 40 countries. A company born from innovation and the desire to offer the highest quality to everyone.Exeltis is a leader in the field of Women's Health. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world.Exeltis has one overarching goal: to offer women support and care throughout every single stage of their lives.General Responsibility: Define, develop and control execution of the clinical drug development strategy and the clinical evaluation strategy, together with the scientific leadership of the area.Specific ResponsibilitiesContribute to the clinical strategic global development plans through the execution and management of the clinical trials.Act as a medical resource to the company as a whole and particularly to the clinical operations department as for example: project plan, protocol and CRF writing, conduct a medical review of the SAP, tables and listings, adverse events, discussions with investigators, medical monitoring, internal meetings, review/resolve medical issues/questions supporting clinical operations team with recruitment/operational issues, and the Integrated Clinical Study. Also this task also includes: the medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues.Provide medical expertise in the review of adverse experiences, together with PV department when appropriated, and discuss patient management issues with investigators. Review laboratory alerts, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan.Coordinate and oversee the interim analysis and final analysis/final clinical study report of the clinical trials, and preparation for manuscript preparation and submission.Engage Medical Experts and investigators in new clinical trialsand interact with all Exeltis affiliates on clinical / medical activities.Contribute for Exeltis to be recognized as a company expert in the nominated therapeutic areas and provide input into all related product development teams.Provide advice across the company on medical, regulatory and clinical matters and activities related to the assigned product portfolio.Develop and maintain up-to-date knowledge of the therapy areas by reviewing the literature, discussions with Key Opinion Leaders and key stakeholders, participating in cross functional interactions, attending scientific congresses, etc.Prepare the medical and scientific evidence together with a sound business case to communicate the benefits of product portfolio to the market and manage advisory boards effectively.Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.Collaborate in the development of clinical documentation of registration dossiers.Provide valid and timely interpretations of medical data from medical research in the assigned Therapeutic Area and identify appropriate communication strategy for external and internal stakeholders.Manage publications related to the brands. Prepare manuscripts, abstracts, posters as well as other scientific documents.Work within any given legal framework, Exeltis and/or Compliance policies, and ensure those around do the same.Requirements and personal skills:Education:MD with specialization in Gynecology (Obs&Gyn) is mandatory.PhD in a relevant field is mandatory.Languages: Fluent English and Spanish.Experience (years/area): +2 years of experience demonstrating a career of increasing responsibility in clinical drug development or medical affairs, specifically in the area of obstetrics or gynecology.Specific Knowledge: Deep practical knowledge of Good Clinical Practices and regulatory requirements, with the ability to work through complex regulatory requirements. Medical leadership in the field women’s health with an understanding of the current practices in wome’s health will be an asset. Ability to direct clinical programs in fields other than women’s health preferably in the field of neglected diseases. Basic knowledge and appropriate application of biostatistics and health economics and outcomes research principles.