Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit Convatec.At Convatec, we're transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We're aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Senior Medical Affairs Specialist, Infusion Care you'll do the same.The Role:Our successful Senior Medical Affairs Specialist, Infusion Care will co-ordinate clinical development and medical affairs activities on a project basis. This may include medical and clinical representation on New Product Development (NPD) Core Teams, Medical/Clinical input and expertise will also be provided for product change control activities, risk management activities (e.g., Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical perspective and providing ad hoc medical advice to support other functions. Additional activities may include supporting medical information requests, medical training, support to the local commercial business unit teams, support for organizing advisory boards, aligned with the Senior Director for Medical Affairs.Duties & Responsibilities:Represent medical / clinical on core/project teams for new product development and change control including risk assessments and IFU (Instructions for Use) development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, and product risk reviews.Review and approve documents from a medical perspective which include, but are not limited to: Clinical Research Protocols, Clinical Study Reports, and Clinical Evaluation Reports.Provide medical input into Health Hazard analyses.Provide medical review support for Medical/Regulatory/Legal (MRL) approval for advertising and promotional material. Working closely with core/project team members to ensure claims and intended use are accurately represented.Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required.Consulted for input on the following activities including but not limited to country and site selection, investigator meetings for clinical studies.Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of medical affairs documents for Regulatory filings and medical responses to health authorities.Represents Convatec and provides medical expertise to relevant teams and External Collaborations: medical information, medical training.Represent the organization in scientific and professional meetings where appropriate.About you:Minimum of a bachelor's degree in Nursing / Medical Degree / Allied Health or equivalent Life Sciences Degree with at least 3 years post qualification experience in diabetes management and/or infusion care.Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.Shows consistency among principles, values and behaviours.Effective use of oral and written communication skills to influence, inform or guide others.Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components.A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delay.Solid understanding of project planning and project management methods and the ability to apply them.Great communication and interpersonal skills.Working ConditionsThis role will predominantly be working from home with occasional travel where needed for team meetings/events.Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.This is stepping outside of your comfort zone.This is work that'll move you.Equal opportunitiesConvatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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