Regulatory/Publishing Professional

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Assemble and Compile electronic and paper submissions including Annual Reports for ANDA/NDA/BLAs and DMFs. Types of submissions also include those for IND support and Periodic Adverse Drug Events. Coordinate reviews of submissions by Product Managers. Responsible for coordination of workload, managing and conducting related training, assuring full coverage of teams duties, assist in SOP creation/maintenance as needed.Qualifications
BS/BA science, healthcare, or technology - or equivalent requiredAbility to provide teams with direction on the regulatory guidances, regulations, and standards as well as the internal processes associated with compliant electronic regulatory submissions. Direct experience with Core Dossier and ISI Toolbox publishing tools required. Experience with eCTD publishing tools desired. Problem solving skills needed for conflicting priorities and goals. Excellent interpersonal and negotiation skills are essential. Organizational and time-management skills, in addition to strong attention to detail are critical. At least 2-4 years in an FDA regulated work environment. Must be proficient in the use of Microsoft Word and PowerPoint. Experience in the use of electronic document management systems and tracking databases required.

${abbott.description.certifications}Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click on the Apply Now buttonTo learn more about Abbott and view other opportunities, please visit: http://www.abbott.com/career/career_center.cfm
REQUIREMENTS
Please see Job Description