Clinical Medical Writer (CER) (EU MDR)
Clinical Medical Writer (CER) (EU MDR)
We welcome you to join Philips as a Medical Writer CERs supporting our Ultrasound product line in our Bothell, WA location.
In this role, you have the opportunity to
The Medical Writer CERs is responsible for the preparation of processes, templates, and documents that support the creation of Clinical Evaluation Reports (CERs) and other presentations, publications, and regulatory writing needs of the Philips Clinical Affairs department:
- Collect, appraise and analyze clinical data pertaining to a medical device.
- Write documentation, such as Clinical Evaluation Reports (CERs) supporting regulatory submission.
- Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, etc.) and external (clinical consultants, subject matter experts, regulatory agencies) stakeholders to ensure comprehensive analysis of clinical evidence.
- Ensure appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), and supporting the timely publication of study results.
- Create procedures and workflows related to the Clinical Development department. Review, assess, and revise document preparation procedures and SOPs as to their efficiency, workflow, and implementation.
You are responsible for
- Design, implement and train on clinical processes and procedures that ensure appropriate clinical evaluation is performed
- Write study reports and assist with preparing submissions to applicable regulatory authorities.
- Write Clinical Evaluation Reports summarizing available clinical evidence.
- Proactive and flexible attitude with strong work ethic.
- Able to quickly assess and understand stakeholder needs.
- Ability to set priorities, work independently without direct supervision as well as part of a team.
- Conscientious and precise delivery of work, even when under time pressure.
- Open and clear communicator.
- Proven track record of delivering clinical results, on time, within budget and in compliance to SOPs and regulations.
- Comprehensive understanding of clinical trial regulations across multiple regions and work precisely according to procedures, rules and regulations and able to keep oversight on processes.
You are a part of
This position offers the opportunity to impact lives through the development and testing of quality Philips products and solutions that help countless people all over the world. We have a fantastic work environment and culture that is respectful and rewarding, and offers opportunities to develop and grow both personally and professionally
To succeed in this role, you should have the following skills and experience
- Scientific or medical education (preferably Masters or PhD degree preferred in Biomedical Science or Health related field, or MD).
- Experience with research methodology (including clinical investigation design and biostatistics).
- Experience with relevant medical and scientific literature databases.
- Experience with medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
- Strong writing skills to produce quality clinical documents.
- A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations and EU regulations.
- >5 years of experience in a similar role in the Medical Device or Pharma industry.
- Excellent verbal and written communication skills (English); multiple languages is a plus.
- Ability to collaborate effectively with various teams - clinical operations, engineering, cross-functional team members, as well as external partners.
- Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment.
- Proficient computer skills across multiple applications, proven ability to apply statistics into method development and sample analysis; experience with statistical software is a plus.
- Experience writing MEDDEV 2.7.1 rev 4 and MDR compliant CERs is a plus
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.
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