Manager Clinical Affairs

Job Title: Manager Clinical Affairs(Medical Office)- DXR

Job Responsibilities:

- Leads the team of Medical Writersandsupports in writingcomprehensive and compliant Clinical EvaluationDocuments(CEP, CER, State of the Art, PMCF Plan and Reports),and clinical sections of regulatory submissions, employing expert-levelmedical writing skills andadhering to internal procedures, templates, and external standards, regulations, and guidance.

- Hasdeep levelknowledge ofEU MDR (Regulation (EU) 2017/745)

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

-Collaborates with multidisciplinary teamsto develop robust clinical developmentstrategiesfor 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 Safetyand Post Market Surveillance.

-Troubleshoots complex issues related toclinical data collection, analysis, and reporting,leveragingadvanced analytical skills to ensure data integrity, accuracy, and consistency across studies.

-Supports clinical engagement with regulatory authorities, including Notified Bodies and the FDA

-Providesproactive 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 effectivelywith internal and external stakeholders, ensuring clarity and alignment on projectobjectives, milestones, and timelines,facilitatinginformeddecision-makingand fostering collaborative relationships.

-Facilitatesinteractionswith colleagues todetermineand implementoptimalapproaches for evidence generation and clinical study design, fostering a culture of innovation and excellence within the clinical development team.

-Presents findingsfrom 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,facilitatingthe execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs.
-Facilitatesongoing collaborationand interaction between internal teams, fostering a culture of cross-functional teamwork and knowledge sharing to drive project success.

Minimum required Education:
Master's Degreein 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 ordemonstratedsubject matter expert in technology/therapeutic domainexpertiseor 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 atthe 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 wewon'tstop until everybody everywhere has access to thequalityhealthcare that we all deserve. Do the work of your life to help the lives of others.
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Ifyou'reinterested 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.