Manager Clinical Affairs

Job Title: Manager Clinical Affairsu00A0(Medical Office)- DXRu00A0

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Job Responsibilities:u00A0

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- Leads the team of Medical Writersu00A0andu00A0supports in writingu00A0comprehensive and compliant Clinical Evaluationu00A0Documentsu00A0(CEP, CER, State of the Art, PMCF Plan and Reports),u00A0and clinical sections of regulatory submissions, employing expert-levelu00A0medical writing skills andu00A0adhering to internal procedures, templates, and external standards, regulations, and guidance.u00A0

- Hasu00A0deep levelu00A0knowledge ofu00A0EU MDR (Regulation (EU) 2017/745)u00A0

-u00A0Analyzesu00A0clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategicu00A0objectives, providing recommendations for protocol optimization and enhancement.u00A0

-u00A0Collaborates with multidisciplinary teamsu00A0to develop robust clinical developmentu00A0strategiesu00A0for 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 Safetyu00A0and Post Market Surveillance.u00A0

-u00A0Troubleshoots complex issues related tou00A0clinical data collection, analysis, and reporting,u00A0leveragingu00A0advanced analytical skills to ensure data integrity, accuracy, and consistency across studies.u00A0

-u00A0Supports clinical engagement with regulatory authorities, including Notified Bodies and the FDAu00A0

-u00A0Providesu00A0proactive 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.u00A0u00A0Disseminates 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.u00A0

-u00A0Communicates effectivelyu00A0with internal and external stakeholders, ensuring clarity and alignment on projectu00A0objectives, milestones, and timelines,u00A0facilitatingu00A0informedu00A0decision-makingu00A0and fostering collaborative relationships.u00A0

-u00A0Facilitatesu00A0interactionsu00A0with colleagues tou00A0determineu00A0and implementu00A0optimalu00A0approaches for evidence generation and clinical study design, fostering a culture of innovation and excellence within the clinical development team.u00A0

-u00A0Presents findingsu00A0from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions.u00A0

-u00A0Builds relationships with Key Opinion Leaders (KOLs) and Investigators,u00A0facilitatingu00A0the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs.u00A0
-u00A0Facilitatesu00A0ongoing collaborationu00A0and interaction between internal teams, fostering a culture of cross-functional teamwork and knowledge sharing to drive project success.u00A0

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Minimum required Education:u00A0
Master's Degreeu00A0in Life Science or equivalent.u00A0
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Minimum required Experience:u00A0

Minimum 15-17 years of experience with Masters in areas such as Clinical Research, MedTech, Healthcare Administration or equivalent.u00A0

Experience writing Clinical Evaluation Documents (CEP, CER,u00A0State of the Art, PMCF) in compliance with Regulation (EU) 2017/745 is mandatoryu00A0u00A0

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Preferred Education:u00A0
MD/PhD or equivalent.u00A0
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Preferred Experience:u00A0

15-17 years of experience with Bachelor's/Master's in areas such as clinical research or equivalent.u00A0

Experience in MedTech and understanding of Health Care Administration or equivalent.u00A0

2+ years of experience in leading teams oru00A0demonstratedu00A0subject matter expert in technology/therapeutic domainu00A0expertiseu00A0or equivalent.u00A0

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Preferred Skills:u00A0
u2022 Regulatory Complianceu00A0
u2022 Data Analysis & Interpretationu00A0
u2022 Continuous Improvementu00A0
u2022 Business Acumenu00A0
u2022 Project Managementu00A0
u2022 Strategic Planningu00A0
u2022 KPI Managementu00A0
u2022 Document Auditingu00A0
u2022 Medical Terminologyu00A0
u2022 Medical Writingu00A0
u2022 Regulatory Requirementsu00A0
u2022 Clinical Evaluation Methodologiesu00A0
u2022 Clinical Evidence Generation Strategyu00A0
u2022 Report Writingu00A0

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How we work togetheru00A0
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.u00A0
Onsite roles require full-time presence in the companyu2019s facilities.u00A0
Field roles are most effectively done outside of the companyu2019s main facilities,u00A0generally atu00A0the customersu2019 or suppliersu2019 locations.u00A0
Indicate if this role is an office/field/onsite role.u00A0

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About Philipsu00A0
We are a health technology company. We built our entire company around the belief that every human matters, and weu00A0won'tu00A0stop until everybody everywhere has access to theu00A0qualityu00A0healthcare that we all deserve. Do the work of your life to help the lives of others.u00A0
u2022 Learn more aboutu00A0.u00A0
u2022 Discoveru00A0.u00A0
u2022 Learn more aboutu00A0.u00A0
Ifu00A0youu2019reu00A0interested 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 careu00A0.u00A0