Publishing Associate II

Profile

Publishing Associate II, Regulatory Affairs Job Summary: The candidate will be expected to independently prepare and review many types of regulatory submissions including IND, NDA, ANDA and BLA filings according to FDA format & submission regulations and guidances.  The applicant will be responsible for authoring publishing work instructions & guidance documents. The Publishing Associate II will be expected to share their knowledge and experience and provide guidance to other associates and coworkers. Additional types of assignments may be given, as needed.Responsibilities:The applicant may assist in cross-functional projects with the IT department and RA management for, but not limited to, the following:FDA Electronic Submission Gateway (ESG) AccountElectronic Signatures and certificates for the RA departmentAll publishing software applicationsThe candidate must have the ability to work independently and manage/prioritize projects to ensure targeted publishing timelines are met. Excellent communication and personal skills are necessary.Independently assemble and submit:Original IND/NDAs/ANDAs/BLAsAmendmentsSupplementsAnnual ReportsPADER ReportsControlled CorrespondenceFDA Meeting RequestsOther as requiredEvaluate documents for submission readiness, correct as neededAuthor and Review Best Practices/Work InstructionsRevise established Publishing Procedures based on Company Needs or FDA RequirementsRepresent Regulatory Affairs in MeetingsProvide mentorship to coworkersEducation/Qualifications: A minimum of 2 years’ experience in regulatory submission publishingA Bachelor’s degree, preferably in a scientific or other technical discipline is preferredExperience with the FDA Electronic Submission Gateway (ESG) is requiredExperience with electronic submission software requiredKnowledge of all current FDA submission regulations and requirements is requiredExperience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required

Company info

Lannett Company, Inc.
Website : http://www.lannett.com