Director Medical Writing & Clinical Development

Job Title

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).

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).

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