Director Medical Writing & Clinical Development

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 Us

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.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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