Posted on Oct 12th 2019

Medical Writer

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

415825

保存职位

Job Title

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

  • 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) partners 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.
     

You are a part of

The Medical Writing Team of the Clinical and Medical Affairs supports medical writing deliverables across Philips's Precision Diagnostic (PD) Cluster. 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 should have the following skills and experience

  • MSc or Ph.D. degree preferred in Biomedical Science or Health-related field or M.D. or Pharm.D.
  • Preferably 2+ years of experience in a similar role in the Medical Device or Pharma industry
  • Demonstrated solid 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
  • 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 English, other languages would be an advantage
  • Experience writing MEDDEV 2.7.1 rev 4 and MDR compliant CERs and PMCFs is a plus.

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.

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你不知道的飞利浦

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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