Author and edit lean high quality clinical regulatory documents companywide for sense, clarity, accuracy.
Assist in authoring of a wide range of documents, including investigator’s brochures, clinical study protocols and reports, integrated summaries, nonclinical summaries, and SOPs.
Create, manage and communicate the document timeline to ensure all reviews are completed in predetermined timeframe.
Lead cross functional review process for all documents being authored.
Lead comment resolution meetings to ensure internal alignment on documents being authored.
Ensure that documents comply with International Conference on Harmonization guidelines, Jazz Pharmaceuticals SOPs, and Good Clinical Practices.
Qualifications
Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Clear understanding of lean authoring for clinical regulatory documents
A solid understanding of the clinical development process, including the documents that are required at each stage
For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required
Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Experience with a variety of regulatory and clinical documents
Experience in a matrix environment
Excellent written and oral communication skills and demonstrated problem-solving abilities
Ability to handle multiple projects and short timelines
Ability to work cooperatively with colleagues in a wide range of disciplines
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Excellent organizational and time management skills and attention to detail
