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CER Writer

Employer
MSI Pharma
Location
Europe
Salary
Negotiable
Start date
10 Jun 2024
Closing date
10 Jul 2024

View more

Discipline
Clinical Research, Medical Communications, Medical Writing
Hours
Full Time
Contract Type
Contract
Experience Level
Entry level

Job Details

Urgent Job Opening: Clinical Evaluation Report (CER) Writer

Location: Europe - Italy, Spain, UK, Belgium, Switzerland, Poland, Germany, France

About the Role: We are urgently seeking a skilled Clinical Evaluation Report (CER) Writer to join our dynamic team. This role is critical for writing, maintaining, and revising technical documents for Class II and Class III medical devices. While you'll be working primarily on Cardiovascular and Neurology devices, your previous experience in any medical device area is highly valued. This position is available across various European locations, including Italy, Spain, UK, Belgium, Switzerland, Poland, Germany, and France.

Key Responsibilities:

  • Technical Documentation: Write, maintain, and revise Clinical Evaluation Reports (CERs) for Class II and Class III medical devices, ensuring compliance with EU MDR and other relevant regulations.
  • Data Analysis: Analyze clinical data, literature, and post-market surveillance data to support CERs.
  • Collaboration: Work closely with cross-functional teams, including R&D, Regulatory Affairs, and Quality Assurance, to gather and interpret clinical data.
  • Regulatory Compliance: Ensure all documentation meets the necessary regulatory standards and guidelines.
  • Continuous Improvement: Stay updated with the latest regulations and industry standards to continually improve the quality of CERs.
  • Project Management: Manage timelines and deliverables for multiple projects simultaneously, ensuring timely completion of high-quality reports.

Skills and Qualifications:

  • Experience: Minimum of 3 years working as a Clinical Evaluation Writer at a medical device company.
  • Technical Expertise: Strong experience writing technical documents for Class II and Class III medical devices.
  • Industry Knowledge: Familiarity with cardiovascular and neurology devices is preferred, but experience with any medical devices is acceptable.
  • Regulatory Knowledge: In-depth knowledge of EU MDR and other relevant regulations and guidelines.
  • Analytical Skills: Strong analytical and data interpretation skills.
  • Communication Skills: Excellent written and verbal communication skills, with the ability to clearly present complex data.
  • Detail-Oriented: High attention to detail and accuracy in documentation.
  • Team Player: Ability to work effectively within cross-functional teams.
  • Language Skills: Proficiency in English is required; additional European languages are a plus.

Benefits:

  • Flexible Location: Opportunities available in multiple European countries.
  • Professional Growth: Continuous learning and development opportunities.
  • Collaborative Environment: Work with a supportive and dynamic team.
  • Competitive Compensation: Attractive salary and benefits package.

Apply Now! If you are a dedicated professional with the required skills and experience, and you are ready to take on a challenging and rewarding role, we want to hear from you! Please submit your CV and cover letter outlining your relevant experience and why you are the ideal candidate for this role.

Company

Founded in 2011, MSI Pharma specialises in recruitment and talent acquisition for pharmaceutical, biotech and life sciences staff on a permanent and interim basis.

We work in partnership with leading global brands and have a presence in the UK, DACH region, and North America.

Company info
Website
Location
2nd Floor, Goat Yard
Albion House
20 Queen Elizabeth Street
London
SE1 2RJ
United Kingdom

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