Associate Director, International Medical

Associate Director, International Medical Review and Medical InformationLocation: Barcelona, Spain This is what you will do: The Associated Director of International Medical Review and Medical Information is responsible for supporting above country, International level medical review as part of the Medical, Legal, Regulatory (MLR) Review Committee and perform Medical Information activities pertinent to the International region. Service functions within assigned therapeutic area(s) (TAs), including but not limited to the medical review of promotional and nonpromotional scientific materials, and implementation of medical information deliverables within set timelines via crossfunctional collaboration. This role is responsible for developing and maintaining current, broad, and indepth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease areas, ensuring high quality standards are applied for end deliverables to fulfil internal and external regulations. As necessary, this individual may support broader activities in the department of Global Medical Communications.

This may include development of scientific content, training materials, presentations and other documents, and participation in other activities (e.g. congresses). The employee carries out this role in accordance with departmental SOPs, corporate policies and other legal and regulatory requirements. You will be responsible for: Medical Review support may include but is not limited to: Representing medical function in the MLR Review Committee and ensuring scientific / medical / clinical accuracy, relevance and completeness of data, appropriateness of references cited and that promotional claims within materials are adequately supported by data.This would require developing and maintaining current, broad, and indepth knowledge of pathophysiology, diagnosis, drug therapy, standards of care, competitive landscape, desired patient outcomes, and clinical outcomes associated with assigned Alexion products and disease states.Providing medical / scientific expertise to crossfunctional stakeholders (e.g.

commercial, medical, patient experience etc. teams) for appropriate disease and product material development. Collaborating with Medical Affairs Directors/Team leads to ensure promotional and nonpromotional materials are aligned to medical strategyCollaborate with the other reviewers, process coordinator, and project owners to ensure appropriate support and timely reviewsIdeally, familiarity with the ABPI code of practice Medical Information support may include but is not limited to: Understanding and effectively applying/complying with appropriate ethical, legal and regulatory standards, including those for responding to unsolicited requests for information, on / off label inquiries, and product promotion. Serving as the scientific expert in the given therapeutic area(s) (TA) and as the escalation point for triage of complex inquiries from the contact center; Help with inquiries requiring escalation or customization; maintaining uptodate medical information and knowledge management systems / repositories, as appropriateEnsures compliance with workflow procedures and standardsParticipating in medical information booth activities both during preparation for and during professional scientific meetings / medical congresses.This may include staffing the medical information booth and responding/documenting HCP inquiries, ensuring medical information resources are indate, crossfunctional colleagues are trained and postcongress reports are completed within a timely manner.Collection and analysis of area metrics and analytics; maintains indepth understanding of historic trends and insights of inquiries received.Contributes to developing a strategy and tactical execution of development / maintenance and review / approval for global medical information response documents, where required.

12 years of relevant experience in reviewing and approving promotional and/or nonpromotional materialsProven record of medical review support, and experience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstractsExperience with/understanding of drug development life cycle, health authority regulations and reporting requirementsProficient in collaboration, negotiating and influencing skillsExcellent written and verbal communication skills Highly proficient in literature searching and medical writing skillsHighly detailoriented in review of diverse materials, and in the development of medical information and other documentsSelfmotivated to drive for results, with strong organizational and planning skillsHighly proficient with Microsoft Office SuiteAbility to travel to meetings / conferences (domestic and international) approximately 10% of the time The duties of this role are generally conduc