Careers at Criterion Edge

We’re looking for the best around. Are you interested?

CE is a provider of top-quality regulatory writing services looking for experienced writers/reviewers/MIS experts to join our team. Members of the CE team enjoy support from our project managers and support staff and ongoing training programs to keep them up-to-date on the latest regulatory guidelines.

careers@criterionedge.com

Current Openings

Clinical Evaluation Report Regulatory Writer

Please apply only if you have previous CER writing experience.

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed flexibility, and budget control. Be on the leading edge by applying your regulatory writing expertise to a variety of regulatory writing projects with top industry clients.

Criterion Edge (CE) is seeking a remote contractor for the Clinical Evaluation Report (CER) Regulatory Writer role. The position is responsible for providing regulatory writing expertise for the development of initial and annual update CERs that support the overall global regulatory submission requirements for the client’s portfolio of medical device products.

Please apply only if you have previous CER writing experience.

Specific Responsibilities Include:

  • Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
  • Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
  • Perform routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices
  • Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER
  • Serve as the regulatory writer on assigned CER projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines
  • Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates

Required Experience:

  • Previous experience writing CERs and related documents in accordance with MEDDEV 2.7/1 rev 3 and 4
  • Effective written, verbal and presentation skills in the area of technical/clinical applications
  • Strong command of medical and surgical terminology
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
  • Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
  • Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)

Email your resume/CV and a cover letter to: careers@criterionedge.com.

Scientific Regulatory Writer

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed flexibility, and budget control. Be on the leading edge by applying your regulatory writing expertise to a variety of projects with top industry clients.

Criterion Edge (CE) is seeking a remote contractor for the Scientific Regulatory Writer role. The position is responsible for providing writing expertise for a variety of regulatory documents that support the overall global regulatory submission requirements for the client’s portfolio of pharmaceutical, biotech or medical device products throughout the life-cycle.

Specific Responsibilities Include:

  • Write clinical documents (e.g., Investigator’s Brochure/ Instructions for Use, Clinical Study Reports, protocols, manuscripts, poster and slide presentations) for submission to US and global regulatory authorities
  • Serve as the medical writer on assigned projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines
  • Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates and document content adheres to FDA/EMA or other applicable regulatory guidelines

Required Experience:

  • Previous experience writing regulatory reports and related documents in accordance with applicable global regulatory guidelines
  • Effective written, verbal and presentation skills in the area of technical/clinical applications
  • Strong command of medical and surgical terminology
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
  • Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
  • Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics

Interested applicants, please send a resume/CV and a cover letter. For more open positions, please visit https://criterionedge.com/careers/

Job Types: Part-time, Contract

Scientific Technical Writer

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed flexibility, and budget control. Be on the leading edge by applying your regulatory writing expertise to a variety of projects with top industry clients.

Criterion Edge Inc (CEI) is seeking a remote contractor for the Scientific Technical Writer role. The position is responsible for providing writing expertise for a variety of CMC and technical reports, eCTD modules and related documents that support the overall global regulatory submission requirements for the client’s portfolio of pharmaceutical and biotech products throughout the life-cycle.

Specific Responsibilities Include:

  • Write technical and non-clinical documents (CMC and other relevant non-clinical and technical sections of eCTD Modules 1, 2, 3 and 4, i.e., Pharmaceutical Development Report, Quality Overall Summary, QbD summaries for annual reports, pharmacokinetics and toxicology reports, etc) for submission to US and global regulatory authorities
  • Serve as the medical writer on assigned projects, collaborating with the CEI Scientific Quality Manager to meet all project deliverable timelines
  • Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates and document content adheres to FDA/EMA or other applicable regulatory guidelines

Required Experience:

  • Previous experience writing technical reports and related documents in accordance with applicable global regulatory guidelines
  • Effective written, verbal and presentation skills in the area of technical and non-clinical applications
  • Strong command of medical and surgical terminology
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
  • Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
  • Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics

Interested applicants, please send a resume/CV and a cover letter. For more open positions, please visit https://criterionedge.com/careers/

Job Type: Contract