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Clinical Trials, Medical Device, Quality/Risk Management, US Regulatory Affairs
Overview of Role
CACTUS is currently looking to add self-motivated, entrepreneurial members to its medical communications team in the US and UK. This is an opportunity to grow your career and make a greater impact on the lives around you.
Roles & Responsibilities:
Function as a subject matter expert on all matters related to medical devices, including Clinical Evaluation Reports (MedDEV 2.7/1 Rev 4), clinical publications, regulatory writing, and medical communications projects
Review the work done by the in-house team of CER writers
Train new writers on writing CERs for medical devices
Responsible for continuous skill building for the in-house team of writers
Accountable for quality of documents delivered to the client
Participate in client pitches and in organic and new business development activities
Participate in thought leadership activities, including developing White Papers and facilitating advisory board/panel meetings at industry conferences
development/regulatory affairs for medical devices
Deep domain expertise in clinical evaluation of medical devices and thorough understanding of MDR and MedDEV 2.7.1 Rev 4 guidelines
4-5 years of experience in the development of Clinical Evaluation Reports for all classes of medical devices in a CRO or medical device company setting; experience of working with cross-functional CER review teams in sponsor company
Experience of working with Notified Body auditors and medical device regulators will be an added advantage
Excellent literature evaluation and summarization skills; familiar with literature search tools, literature databases, EndNote, etc.
People management experience
Wiling to travel to client meetings or to office locations globally when needed
Internal Number: 101
About Cactus Communications
Cactus Communications was founded in 2002 with the aim to help researchers through editing and translation services initially. We now aim to be the global organization that has helped increase the speed and impact of research publishing and dissemination by helping all researchers become more effective. We partner with researchers, universities, publishers,?academic?societies, and life science organizations?through innovative products and services developed under the brands Editage, Cactus Life Sciences, R, Impact Science, UNSILO, and Cactus Labs.
CACTUS has offices in 9 countries and has a global workforce of over 3000 experts with experts from over 190 countries. Our culture is built on inclusion, collaboration, high performance, and opportunity. This combination helps professionals at CACTUS make a difference individually and collectively.
CACTUS Life Sciences provides scientific writing services to the Top 10 global pharmaceutical, biotech, and medical device companies. The team comprises writers with advanced degrees in medicine or the life sciences.
Services we offer include:
Clinical trial publications
Medical Affairs educational content
Medical devices documentation