Job Description

QUALITY CONTROL & TECHNICAL EDITING

• Perform quality control (QC) reviews of documents for clinical trials across multiple therapeutic areas and at various stages of development (including, but not limited to, clinical protocols, investigator brochures, clinical study reports, patient narratives, informed consent forms, assents, and patient diaries) within established timelines
• Verify clinical data against multiple sources (e.g., biostatistical data listings, protocols, investigational brochures)
• Verify accurate use of grammar, punctuation, and spelling
• Verify accurate layout and formatting (numbering, headers, footers, and other MS Word style settings)
• Verify functionality and accuracy of intra-document links (e.g., bookmarks, citations, cross-references, hyperlinks) in Word and in Adobe Acrobat
• Adhere to the specifications outlined in SOPs, working instructions, style guides, document templates, and document samples
• Ensure documents comply with appropriate International Council on Harmonisation (ICH) standards and regulatory guidance
• Perform other tasks such as tracking documents throughout the development process and document publishing, when needed
• Mentor and provide guidance/training to less senior QC staff as applicable

NOTE: JOB TITLE INTERNALLY KNOWN AS QUALITY CONTROL ASSOCIATE, MEDICAL WRITING

NOTE: THIS IS NOT A QUALITY ASSURANCE (QA) LABORATORY POSITION.

Qualifications

EDUCATION

• Relevant educational background, such as a Bachelor’s degree, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities
• Equivalency is defined as a minimum of a 2-year Associate’s degree in addition to 2 years of experience in QC of medical, scientific, and/or technical documents

SKILLS AND EXPERIENCE

• Minimum 2 years of experience in Quality Control of medical, scientific, and or technical document required 
• Excellent written English
• Demonstrate strong attention to detail and a high level of quality, consistency, and accuracy in work products
• High degree of organization, flexibility, and ability to manage multiple projects at any given time
•  Demonstrated success working both solely and collaboratively with teams in a self-directed, remote working environment from a dedicated home office workspace (online availability between core hours of 9:00am – 4:00pm)
• Excellent communication skills and the ability to maintain a positive attitude under pressure
• Intermediate experience with Microsoft applications and Adobe PDF
• Document formatting and/or correction using Microsoft Word styles and templates is preferred

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.