The Publisher III works with US and/or ex-US RA colleagues, and Global Project Teams to publish and quality check low to medium impact (with respect to internal visibility, risk, complexity, and criticality) submissions. Coordinates publishing with offsite publishers. Creates cover letters and forms for IND amendment submissions. Manages IND safety report and 30-day investigator submissions. Manages departmental routine submission schedules. Works with minimal supervision. Suggests and may assist in the implementation of process improvements. Key Responsibilities Include:
- Publishes low - medium impact (with respect to internal visibility, risk, complexity and criticality) submissions, creating compliant submissions to be used in global regulatory submissions. Submissions are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency.
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances. Includes verification of bookmarks, hypertext links and tables of content in global submissions.
- Prepares, Quality checks (QCs), ships and archives AdPromo submissions.
- Coordinates submissions with offsite publishers.
- Transmits submission to FDA, archives submission and sends submission notifications.
- Creates cover letters and forms for Investigational New Drug (IND) submissions and independently manages IND 30-day investigator update and safety report timelines.
- Manages routine submission schedules. Expedites, manages and coordinates a multitude of interrelated activities for teams in the development of published submissions within the required timelines.
- Represents Publishing on teams as necessary, elevates timeline issues. Acts as publishing representative on cross-functional teams such as process improvement teams.
- Drafts and or/edits internal process and standards documents relating to publishing and publishing deliverables. Assists in the testing and validation of software updates or enhancements.
- Tracks departmental metrics and metrics associated with submission publishing and rework.
- Required Education: High School diploma or equivalent
- Preferred Education: Bachelor's Degree
- Required Experience: Three years pharmaceutical or industry related experience
- Experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher/DocuBridge/Insight platform, ISI Toolbox, Adobe Acrobat. Thorough understanding of MS Word and authoring templates/tools e.g. ISIWriter and DocX Checker
- Preferred Experience: 2-4 years submission and/or publishing experience. 3+ years creating reports and/or regulatory submissions, working with customers in planning and complication of reports on submissions
- Experience with technical capabilities in the areas of scanning and bookmarking.
- NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education