For The Candidates

(847) Area Code         Chicago area             

Submissions Operations Publisher / Senior

PRIMARY FUNCTION:
Work with US and/or ex-US Global Pharmaceutical Regulatory Affairs (GPRA) areas and Global Project Teams in the creation of compliant regulatory submissions. Submissions are usually medium to high impact with respect to internal visibility, risk, complexity, and criticality.

MAJOR RESPONSIBILITIES:
• Create regulatory compliant submissions to be used in global regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency.
• Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions.
• Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness.
• Represent Regulatory Operations Publishing on Global Project Teams or Submission teams as necessary, elevate timeline issues.
• Act as publishing representative on cross-functional teams such as process improvement teams.
• Create and finalize internal process and standards documents relating to publishing and publishing deliverables.
• Assist in the implementation, testing, validation of software updates or enhancements.
• Track metrics associated with submission publishing and rework.
• Identify the possible impact of changes in regulations to the software and the business processes that support global submissions.
• Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.
• Remain current with Publisher University curriculum, based on individual plan developed by supervisor.

ACCOUNTABILITY / SCOPE:
• Negotiate project outcomes and deliverables to meet the conflicting demands of time and deadlines.
• Responsible for compliant regulatory submissions that impact the global Abbott business. Submissions are complex and involve multiple country formats needed for simultaneous global submissions.
• Assess software releases for new functionality and impact to the business process.
• Make recommendations regarding process improvements.
• Work independently with little direct supervision.

PROBLEM SOLVING:
• Translate management or customer needs into design input. Define the nature of the stated business or technical problem.
• Anticipate future problems, resolve current issues, learn and adjust based on prior results.
• Recognize the broader implications of actions and proposals on the final project outcome. 

 

Pharmaceutical Products Group

• 3-6 years submission experience and/or publishing experience.
• 3+ years in creation of global regulatory submissions that involved working with customers in planning and compilation of submissions.
• Expert in the use of publishing-related software tools including Documentum, eCTDXPress, ISI Toolbox, Adobe Acrobat. Thorough understanding of MS Word. Experience in working with multiple systems.
• Project Management skills including good communication, negotiation and impact assessment.