Index global regulatory submissions and health authority communications, according to established Standard Operating Procedure and standards, ensuring integrity and quality of the metadata.
Responsibilities include but are not limited to the technical preparation of submission documents (individual documents and compound documents). Meets internal document standards with regards to formatting, timeliness, and submission readiness, with some direct guidance.
Provide advanced publishing services of complex documents using industry standard publishing tools, including submission ready formatting, hyper-linking, and bookmarking.
Provide document management services including electronic document secure storage in the submissions document repository, indexing, and archiving of approved documents in accordance with quality standards.
Perform technical quality check of works of another Specialist.
Recognize how to best interpret and coordinate department specific standard operating procedures, work practices and, health authority guidance on preparing electronic submissions.