AbbVie

Specialist, Regulatory Operations

Employer
AbbVie
Location
Sunnyvale, CA, United States
Posted
Sep 27, 2020
Ref
2007093
Required Education
High School or equivalent
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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.

Responsibilities :
  • 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

Qualifications
  • 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

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.