Job TitleClinical Development Scientist
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
The Clinical Development Associate is responsible for the preparation of processes, templates, and documents that support the creation of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other presentations, publications, and regulatory writing needs of the Philips Clinical Affairs department:
You are responsible for
- Collect, appraise, and analyze clinical data pertaining to a medical device.
- Write documentation, such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports supporting regulatory submission.
- Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, 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), Post-Market Clinical Follow-Up (PMCF) Reports, 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 regarding their efficiency, workflow, and implementation.
- 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.
- Write Post-Market Clinical Follow-Up Reports summarizing available post-market evidence.
You are a part of
Philips has offerings spanning components, modules, systems, turnkey projects, and services, and is recognized as a pioneer and leader in the healthcare industry. We simplify healthcare by focusing on the people in the care cycle – patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system and providers. Philips delivers advanced solutions to health professionals to meet the needs of patients, and to empowered consumers for affordable healthcare whether in hospital or at home.
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 and PMCFs is a plus.
In return, we offer you
We believe that every growth period creates an exceptional career runway. In fact, the leadership team gets out of bed every morning with the sole focus of growing the business and growing the people who contribute to it. Luckily, you are the benefactor of this unique opportunity and leadership commitment- likely to experience an exciting high stakes, mobility-focused environment from which to create your own future – personally, professionally & financially.
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. Learn more by watching this video.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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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