Regulatory InSight Publisher Job at Katalyst Healthcares & Life Sciences in Gain

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Summary:

• The Regulatory InSight Publisher, Publishing will be part of the Regulatory Operations Publishing Group and will coordinate the publishing process with Regulatory Affairs (RA) to ensure timely and accurate submissions to the FDA and other agencies.

Responsibilities:

• Coordinates publishing efforts for all submissions to FDA and other global health authorities.
• Creation of templates and profiles within InSight Publisher according to RA and FDA specifications; management of documents within Documentum; assembly of submissions through the use of established templates and guidelines; and XML backbone generation for electronic submissions.
• Use of the submission document management system and responsible for managing the quality of all eCTD submissions.
• Reviews work of RA Operations Associates and Specialists to ensure accuracy and compliance of work produced.
• Attends Publishing Group and RA meetings and interacts closely with department members.
• Assists RA in interpreting FDA and ICH guidance as it relates to the established CTD templates, in addition to numerous other submission types (e.g. NDA, ANDA, IND, DMF, PSUR, Annual Reports, Pre-Meeting Packages).
• Assesses impact of regulation changes to current work procedures and SOPs.
• With the Manager, updates procedures and SOPs as appropriate and trains personnel regarding all revisions.
• Anticipates Regulatory consequences to changes in application format, and works with RA to ensure all documentation both received and generated is accurate.

Education:

• Minimum of a Bachelor degree from an accredited college or university.

Experience:

• 5+ years’ experience with electronic submission software and/or other related industry specific software.
• Strong experience in Insight Publisher is a must.
• Knowledge of ICH and FDA guidance/regulations.