NJ Employer Team Lead (Publishing/ Regulatory Affairs) in Bridgewater, New Jersey

Responsibilities:Develops and mentors associates by providing expertise in all clinical electronic publishing submission types applicable to their region of responsibility.Leads team of publishers (Sr. and Jr. Levels), manages people.Coordinates and triages all submission publishing work activity to teamProvides input into client processes and software to Delivery manager for communication back to client.Communicates issues and concerns to Delivery Lead proactively.QCs work through spot checks on a regular basis.Understands client expectations.Main point of contact for client LRAs.Skills Required:Regulatory Affairs knowledgeElectronic Submission Publishing tools a must (eCTD, Insight) at least 5-7 years experience in eCTD submission publishing.Different submission procedures (US, Caribbean, South America & Canada )Good Clinical Practice (GCP)21 CFR part 11Excellent verbal & written communicationPeople Management experience, 3-5 years preferredAbility to prioritize workExcellent people management skills.Qualifications:Diploma/ Bachelor degree in Pharmacy, Life-ScienceMinimum of 5 - 7 years in Regulatory Operations and Electronic Clinical Submission PublishingPerformance Standards:MeasurableEstablish work practices and procedures in the team.Compliance with KPIsCustomer satisfaction indexNon-MeasurableSelf-motivationAchievement building orientationRelationship building abilityInclination towards being process drivenGoing out of way to satisfy the externalVEVRAA Federal ContractorRequest Priority Protected Veteran ReferralsEOE -Veteran /Disabled/Minority/AA/F/M/SO