Director Medical Writing & Clinical Development

Philips; München; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading health technology company in Munich is seeking a Director of Medical Writing & Clinical Development. This role involves guiding a skilled team to deliver high-quality clinical documents and ensuring compliance with EU FDA standards. Candidates should have over 10 years of experience in medical writing within regulated environments and possess a Master's in life sciences. The position requires collaboration across various teams and a passion for optimizing processes.

Leistungen

Opportunity for career development

Work in an inspiring environment

Qualifikationen

• 10+ years experience in FDA regulated medical device environments.
• Detailed knowledge of medical device regulations for FDA and EU.
• Proven experience in managing and developing teams.

Aufgaben

• Lead the medical writing team in compliant document delivery.
• Compile and analyze clinical data for medical devices.
• Translate complex scientific data into clear narratives.

Kenntnisse

Clinical evidence development

Regulatory compliance

Team management

Data analysis

Process automation

Project management

Ausbildung

Master’s degree in life sciences or equivalent

Tools

Azure Dev Ops

Jira

Tableau

PowerBI

Jobbeschreibung

Job TitleDirector Medical Writing & Clinical Development

Job Description

The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert, mentor, and strategic guide that integrates multiple data and evidence streams (published literature, society guidelines, Philips’ clinical studies, Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification, evidence generation, and surveillance/safety).Please apply in English. Applications submitted in any other language won't be considered.

Your role:

• Leads the medical writing team in planning and delivering high-quality, compliant documents through effective resources, budget, and timeline management.
• Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation).
• Author and maintain clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports, Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities.
• Drives collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research & Development, and Regulatory Affairs.
• Develops clinical evidence strategies for New Product Introductions, including performance claims and coordination on usability and non-clinical evidence.
• Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy.
• Optimizes medical writing processes by identifying and implementing automation, standardization, and workflow efficiencies.
• Translates complex scientific data into clear, impactful narratives for regulatory bodies, clinicians, and stakeholders to support product development and commercialization

You're the right fit if:

• You’ve acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development of clinical evidence/documents (manuscripts, scientific abstracts, conference presentations/posters, reports based on clinical studies, and data/analytics).
• You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products.
• You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile), mentoring, training, performance management and development of team members.
• You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions.
• You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, compliance, and reduce time to market.
• You have a minimum of a Master’s degree in life sciences or equivalent discipline (REQUIRED).
• Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology, Health Services Research, Health Economics or Medicine) and healthcare quality improvement.Project management background and familiarity with agile tools (Azure Dev Ops/Jira), information management (Confluence, Distiller, Endnote) or dashboarding/visualization (Tableau, PowerBI).
• Near-native level of English

How we work together
We believe that we are better together than apart. For this role it means working in-person at least 3 days per week.

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.

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