Clinical Development Scientist & Medical Writer

Clinical Development Scientist & Medical Writer (Contract)

Location: High Tech Campus Eindhoven

Duration: 12 months

Hours/week: 40

Budget range: €3.500- 4.900 per month

Key education/ experience that is needed for the job:

PhD, MD degree with experience on writing Clinical Evaluation Reports (CERs) This should be visible in your CV. First screening will be done on terms as Clinical Evaluation Reports (CERs)!

In this role, you will have the opportunity to:

Impact through the development and testing of quality Philips’s products and solutions that help countless people worldwide.

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.

You will be responsible for:

• Collect, appraise, and analyse clinical data pertaining to a (medical) product.

• Write documentation, such as Clinical Evaluation Reports (CERs), and Post-Market clinical Follow-up reports (PMCF) supporting regulatory submission.

• Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, Marketing, legal, etc.) and external (clinical consultants, subject matter experts, regulatory agencies, etc.) 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.

• Provide support for the operation of clinical trials and product approvals in the USA, EU and ROW

• Lead clinical risk assessment throughout – from ideation through Market introduction

• Development of evidence generation & dissemination strategies to support innovation projects

• Delivery of Clinical Development Plans requirements (i.e., EU, China)

To succeed in this role, you should have the following skills and experience:

• Preferable Masters or PhD degree in biomedical Science or Health-related field or M.D. with 3-5 years of experience in the medical device or Pharma industry

• Trained and experienced in medical writing; systematic review, and clinical data appraisal: MDR compliant CERs and PMCFs is a plus.

• A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations and EU regulations

• Experience with research methodology (including clinical investigations design and biostatistics)

• Experience with clinical budgeting

• Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPS and regulations

• Ability to collaborate effectively with various teams – clinical operations, engineering, cross-functional team members, as well as external partners

• Professional and proficient in reading, writing, and speaking English

You are a part of

Building up the clinical expertise within Philips. You will serve 2 Business Groups in Philips (Grooming & Beauty and Mother and Childcare). Work closely together with several teams including regulatory, Marketing, product development and legal.

The team consists of 5 people – responsible for developing studies.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of YACHT (a Randstad company). As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional. And as a YACHT employee, you can expect to receive ongoing support with your personal development and future prospects. 

YACHT provides all employees with a range of benefits, including pension, social security payments and potential to earn a quarterly bonus as well as a mobile and travel allowance.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.