About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, medical writing, pharmacovigilance, medical affairs, and toxicology to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our customers.

ClinChoice was established in the US in 1995 and has grown to more than 2,000 employees worldwide, with key offices and deliver centers in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

Duties and Responsibilities

The Clinical Technical Editor (CTE) is a member of the medical writing team who is accountable for quality control of clinical documents intended for submission to regulatory agencies.

Key Responsibilities:

• Coordinate and preform our Company’s Quality Control (QC) process for clinical documentation that includes but is not limited to, clinical evaluation reports, clinical study reports, patient narratives, and clinical modules for the common technical document.
• Ensure documents comply with Customer templates and style guides
• Work collaboratively with internal and external medical writers, regulatory publishers and project team members to deliver high-quality clinical documentation in a timely manner.
• Promote the development, implementation, and periodic review of editorial management procedures.
• Support medical writers on the use of tools and technologies to facilitate efficient and compliant document delivery.
• Work within the document management system, as applicable, to ensure security and version control are maintained.
• Review and edit regulatory documents in multiple therapeutic areas to verify:
  • Completeness and accuracy of information.
  • Accurate use of grammar and style.
  • Consistency of text with internal document data displays as well as external reference sources.
  • Application of format standards for electronic documents.
  • Compliance with submission-ready standards.
  • Ensure consistent QC and good document practices are followed across internal authors.

Qualification / Skills / Experience

• BA/BS or higher.
• At least 2 years of editing and/or quality control of technical documentation in a pharmaceutical, biotech, clinical research, or related environment with specific experience in the pharmaceutical industry preferred.
• Excellent written English skills.
• High degree of organization and ability to manage multiple projects.
• Ability to work independently.
• Attention to detail.
• Excellent communication and interactive skills.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity