Job Summary

A Pharmaceutical company has an open position for a Remote Medical Writing QC Manager.

Candidates will be responsible for the following:

• Completing of quality control activities for documents created by medical writing
• Providing QC support for a wide range of documents, including investigator’s brochures, clinical study protocols and reports, integrated summaries, and health authority responses
• Ensuring that documents comply with International Conference on Harmonization guidelines, Jazz Pharmaceuticals SOPs, and Good Clinical Practices

Qualifications Include:

• BA/BS with 3+ years (or advanced degree with 1.5+ years) experience with technical documents in the pharmaceutical industry
• Clear understanding of the clinical development process and documents needed at each stage
• A solid understanding of the ICH and regulatory guidelines for clinical documents
• Excellent written and oral communication skills and demonstrated problem-solving abilities
• Ability to effectively communicate in a matrix environment
• Ability to work cooperatively with colleagues in a wide range of disciplines