lead a team of Submission specialists to ensure all submission tasks are executed efficiently and effectively. Through strong leadership and communication skills, I ensure that my team is motivated and equipped with the necessary resources to achieve project goals on time.Furthermore, I am also responsible for overseeing all aspects of submission content planning and management. This includes establishing and maintaining submission content planners and associated timelines, facilitating… Show more lead a team of Submission specialists to ensure all submission tasks are executed efficiently and effectively. Through strong leadership and communication skills, I ensure that my team is motivated and equipped with the necessary resources to achieve project goals on time.Furthermore, I am also responsible for overseeing all aspects of submission content planning and management. This includes establishing and maintaining submission content planners and associated timelines, facilitating tactical submission team meetings, and preparing content planners for publishing. Additionally, I interface with publishing vendors and fulfill Submission Management functions on Project Teams to support Development, Marketing, and post-marketing regulatory authority applications. Show less

As a Senior Specialist, manages medium to high impact (with respect to internal visibility, risk, complexity, and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Acts as Submission Operations interface with project teams providing guidance and communication of established submission processes and standards… Show more As a Senior Specialist, manages medium to high impact (with respect to internal visibility, risk, complexity, and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Acts as Submission Operations interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.Plans and conducts Kick off submission meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.Coordinates submission publishing with offsite publishers/provides notification to ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issuesPerforms detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’s including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.Trains, and mentors less experienced staff. Show less

As an individual contributor, to work with Submission Management, Area & Affiliate, and product submission teams in the creation of compliant regulatory submissions.Publish regulatory-compliant submissions in paper, NeeS or eCTD and ACTD format using regulatory publishing software tools.Perform detailed quality reviews of published submissions to ensure compliance with AbbVie standards and agency guidance’s. This includes verification of bookmarks, hypertext links and tables of… Show more As an individual contributor, to work with Submission Management, Area & Affiliate, and product submission teams in the creation of compliant regulatory submissions.Publish regulatory-compliant submissions in paper, NeeS or eCTD and ACTD format using regulatory publishing software tools.Perform detailed quality reviews of published submissions to ensure compliance with AbbVie standards and agency guidance’s. This includes verification of bookmarks, hypertext links and tables of content in electronic submissions.Perform post-publishing phases of regulatory submission production including submission dispatch to regulatory agencies or Area & Affiliate staff, submission archiving and Registration Management tasks, where applicableExpedite, manage and coordinate a multitude of concurrent interrelated activities for submission teams and/or multiple products in the development of published Global submissions within the required timelines. Assist with co-ordination of work performed by contracted outsourcing publishers to enable them to complete the necessary tasks.Represent Submission Publishing on submission teams as necessary elevating timeline issues to Submission Management or Functional Manager.Participate on Submission Operations Lessons Learned activities for major submissions.Track metrics associated with submission publishing. Show less

Client: Novartis HealthcareA individual contributor position in Drug Regulatory Affairs Operations including Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, life cycle management, post approval change management) in e-CTD, NeeS and Paper format to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM and ROW).Support the rest of the global publishing team and other temporarily assigned staff in… Show more Client: Novartis HealthcareA individual contributor position in Drug Regulatory Affairs Operations including Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, life cycle management, post approval change management) in e-CTD, NeeS and Paper format to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM and ROW).Support the rest of the global publishing team and other temporarily assigned staff in preparation, quality review, and timely dispatch of drug dossiers.Electronic Submission Tools Handled: ISI eCTDXPress, ISI ToolBox, Lorenz Validator, EURS validator and Rosetta Phoenix. Show less

Preparation of Various Electronic and Paper Submissions for US and EU and ROW Countries.Expertise in Handling Submission like NDA, IND, ANDA and DMF for US FDA. and Different types of eCTD and Nees submission(Electronic and Paper) for Procedures like (CP, DCP, MRP, NP) for EMEA.Expertise in handling tools like “ISI Publisher, eCTD Express, RADARS, Lorenz Validator” and various country specific Validation Tools.

1. Prepares patient narratives, CTRDs, CTDs, literature review, abstracts, manuscripts (simple) working from various data sources including clinical study reports, patient profiles, protocols etc.2. Performs quality control (QC) checking / proof reading of narratives, CTRDs, CTDs, literature review, abstracts to meet customer expectations.