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Clinical Development Scientist / Medical Writer
Job Description
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today, Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
You are responsible for
You are part of
The Medical Writing Team of the Clinical and Medical Affairs supports medical writing deliverables across Philips's Precision Diagnostic (PD) Cluster (Ultrasound). The technology involved includes CT, X-Ray, Ultrasound, MR and imaging software. In PD, we enable the pathway to sustainable, precise, and personalized therapies with predictable outcomes. You will be part of a friendly and open-minded team who always help each other.
To succeed in this role, you'll need a customer-first attitude and the following
In return, we offer you
To be part of a company committed to improving the lives of 3 billion people a year by 2030 through meaningful innovations in Healthcare. We are passionate about offering our employees the challenges, responsibilities, coaching, and learning opportunities needed for their personal and professional development.
We believe in ample reward and special recognition for a job well done, and we welcome the cultural awareness, mutual understanding, open minds, and out-of-the-box thinking that come from the international multidisciplinary
team working.
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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.
Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation.
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.
The salary range for this position is: $94,000-$160,000. The bonus target is 10%. Our benefits can be found here: https://www.careers.philips.com/na/en/best-employee-benefits.
*Montana employees are currently excluded from this requirement at this time.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.
The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.
We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
#LI-PH1
#LI-Remote
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Clinical Development Scientist / Medical Writer
Job Description
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today, Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
You are responsible for
- Collecting, appraising and analyzing clinical data pertaining to a medical device.
- Writing documentation, such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports, supporting regulatory submission.
- Collaborating 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) partners to ensure comprehensive analysis of clinical evidence.
- Ensuring 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.
- Creating procedures and workflows related to the Clinical Development department.
- Reviewing, assessing, and revising document preparation procedures and SOPs regarding their efficiency, workflow, and implementation.
You are part of
The Medical Writing Team of the Clinical and Medical Affairs supports medical writing deliverables across Philips's Precision Diagnostic (PD) Cluster (Ultrasound). The technology involved includes CT, X-Ray, Ultrasound, MR and imaging software. In PD, we enable the pathway to sustainable, precise, and personalized therapies with predictable outcomes. You will be part of a friendly and open-minded team who always help each other.
To succeed in this role, you'll need a customer-first attitude and the following
- Preferably 2+ years of experience in a similar role in the Medical Device or Pharma industry
- MSc or Ph.D. degree in Biomedical Science or Health-related field preferred, or M.D./Pharm.D
- Experience writing MEDDEV 2.7.1 rev 4 and MDR compliant CERs and PMCFs
- Demonstrated understanding of EU regulations, Good Clinical Practice and ICH guidelines
- Experience with research methodology (including clinical investigation design and biostatistics)
- Experience with relevant medical & scientific literature databases and strong medical writing skills to produce quality clinical documents
- Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPs and regulations
- Ability to apply statistics into method development and sample analysis; experience with statistical software is a plus
- Proficient in English; other languages a plus
- Proactive, flexible attitude with strong work ethic; ability to understand stakeholder needs and work independently
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
To be part of a company committed to improving the lives of 3 billion people a year by 2030 through meaningful innovations in Healthcare. We are passionate about offering our employees the challenges, responsibilities, coaching, and learning opportunities needed for their personal and professional development.
We believe in ample reward and special recognition for a job well done, and we welcome the cultural awareness, mutual understanding, open minds, and out-of-the-box thinking that come from the international multidisciplinary
team working.
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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.
Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation.
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.
The salary range for this position is: $94,000-$160,000. The bonus target is 10%. Our benefits can be found here: https://www.careers.philips.com/na/en/best-employee-benefits.
*Montana employees are currently excluded from this requirement at this time.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.
The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.
We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
#LI-PH1
#LI-Remote
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
