Manager Clinical Affairs

Job Title Manager Clinical Affairs Job Description Job Title: Manager Clinical Affairs (Medical Office)- DXR Job Responsibilities: - Leads the team of Medical Writers and supports in writing comprehensive and compliant Clinical Evaluation Documents (CEP, CER, State of the Art, PMCF Plan and Reports), and clinical sections of regulatory submissions, employing expert-level medical writing skills and adhering to internal procedures, templates, and external standards, regulations, and guidance. - Has deep level knowledge of EU MDR (Regulation (EU) 2017/745) - Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement. - Collaborates with multidisciplinary teams to develop robust clinical development strategies for New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from stakeholders such as Marketing/ Regulatory/ Concept Development/ Clinical Science/ Risk Management, Quality, Medical Safety and Post Market Surveillance. - Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging advanced analytical skills to ensure data integrity, accuracy, and consistency across studies. - Supports clinical engagement with regulatory authorities, including Notified Bodies and the FDA - Provides proactive support in claim substantiation and development of scientific materials to disseminate knowledge on the DXR product portfolio; assesses and critically analyzes clinical study data within the clinical study report, synthesizing findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications, contributing to the advancement of scientific knowledge. Disseminates evidence derived from clinical studies, effectively communicating the impact and significance of findings to internal teams and external stakeholders, contributing to the broader scientific community and market understanding. - Communicates effectively with internal and external stakeholders, ensuring clarity and alignment on project objectives, milestones, and timelines, facilitating informed decision-making and fostering collaborative relationships. - Facilitates interactions with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, fostering a culture of innovation and excellence within the clinical development team. - Presents findings from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions. - Builds relationships with Key Opinion Leaders (KOLs) and Investigators, facilitating the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs. - Facilitates ongoing collaboration and interaction between internal teams, fostering a culture of cross-functional teamwork and knowledge sharing to drive project success. Minimum required Education: Master's Degree in Life Science or equivalent. Minimum required Experience: Minimum 15-17 years of experience with Masters in areas such as Clinical Research, MedTech, Healthcare Administration or equivalent. Experience writing Clinical Evaluation Documents (CEP, CER, State of the Art, PMCF) in compliance with Regulation (EU) 2017/745 is mandatory Preferred Education: MD/PhD or equivalent. Preferred Experience: 15-17 years of experience with Bachelor's/Master's in areas such as clinical research or equivalent. Experience in MedTech and understanding of Health Care Administration or equivalent. 2+ years of experience in leading teams or demonstrated subject matter expert in technology/therapeutic domain expertise or equivalent. Preferred Skills: • Regulatory Compliance • Data Analysis & Interpretation • Continuous Improvement • Business Acumen • Project Management • Strategic Planning • KPI Management • Document Auditing • Medical Terminology • Medical Writing • Regulatory Requirements • Clinical Evaluation Methodologies • Clinical Evidence Generation Strategy • Report Writing How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. 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