The Publisher IV works with RA Area & Affiliate colleagues, and cross-functional submission teams to publish and quality check low to high impact (with respect to internal visibility, risk, complexity, and criticality) submissions Coordinates submission publishing with offsite publishers. Creates cover letters and forms for Investigational New Drug (IND), New Drug Application (NDA), Drug Master File (DMF) and Biologic License Application (BLA) submissions. Manages IND safety report, NDA/BLA/DMF annual reports, and 30-day investigator submissions independently. Drafts summary documents for annual reports. Manages departmental routine submission schedules. Works with minimal supervision. Suggests and may assist in the implementation of process improvements. Publishes low - high 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.
Key Responsibilities Include:
- 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, 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), New Drug Application (NDA), Biologic License Application (BLA), Drug Master File (DMF) submissions and independently manages IND 30-day investigator update, safety report and NDA, BLA and DMF annual reports. Drafts summary documents NDA, BLA, DMF annual reports.
- Lead submission publishing for large new NDA/BLA submission, assign tasks to other publishers and coordinate multitude of activities. Expedites, manages and coordinates a multitude of concurrent interrelated activities for teams and/or multiple products in the development of published Global submissions within the required timelines.
- Represents Publishing on submission teams as necessary, elevates timeline issues.
- Creates and finalizes internal process and standards documents relating to publishing and publishing deliverables. Assists in the implementation, testing, validation of software updates or enhancements. Tracks departmental metrics and metrics associated with submission publishing and rework.
- Trains, mentors and may supervise the work of less experienced staff.
- Publishes core package and country specific formatted submissions for Latin American countries. Acts as publishing representative on cross-functional teams such as process improvement teams.
- May also be assigned to work on Advertising and Promotion submissions for FDA OPDP.
- Required Education: High School diploma or equivalent
- Preferred Education: Bachelor's Degree
- Required Experience: Five years pharmaceutical or industry related experience
- Experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher/DocuBridge/Insight platform, ISI Toolbox, Adobe Acrobat
- Experience in a complex and matrix environment. Strong communication skills both oral and written
- Preferred Experience: Five years creating reports and/or regulatory submissions, working with customers in planning and compilation of reports or 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.
- Good organizational and time management skills.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled