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Purcelloleary is recruiting for the role of Clinical Publisher Associate – eCTD. The Clinical Publisher Associate – eCTD collaborates with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines
Primary Responsibilities: Clinical Publisher Associate – eCTD
Functional and Technical Expertise
- Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
- Demonstrate in-depth understanding of ICH CTD format/style requirements and evolving US/OUS agency standards/trends. Apply knowledge to manage a variety of complex submissions
- Provide publishing to influence strategies of upstream contributors/vendors to enable successful implementation with minimal impact to resources and supply chain.
- Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labeling to deliver the submission.
- Understand, log, and manage Incoming Correspondence from and all Records of Contact with the FDA to enable rapid and accurate updates to RAPT and RCTT impacting project timelines and pending approvals.
- Accountable as process owner of a specific process. (e.g., ROCs/IC, RAPT eFiles, Publisher Qualification, CRF/CRT, OUS Submissions, etc.) to technically evaluate, drive improvements and contribute to RQS procedures.
- Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway, and Net [SharePoint]) to ensure compliance. Stay up to date on system and tool upgrades.
- Demonstrate in-depth understanding of complex multiple FDA forms and apply project knowledge to ensure accurate submissions.
- Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission.
- Coordinate with RACMC Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct.
- Leverages internal and external forums to continue to develop and share regulatory and drug development expertise around electronic submission structure and content.
- Educate and influence cross-functional DCoE, Sci Com, and Labeling consultants on submission requirements for CRFs, datasets, literature references, and labeling, to ensure alignment and reduce potential technical issues impacting submission timelines.
- Lead the coordination with other publishing centers and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy.
- Drive improvement in SME area with registration process owner and management and incorporates changes to job aids, Publisher Qualification program, and RQS procedures.
- Influence Regulatory Scientists and/or Directors to complete and sign cover letters and forms in critical timelines to ensure on time submissions.
- Drive process and influence Regulatory Associates and cross-functional partners (CMC Director) to review RAPT reports and update status of US applications per required timelines.
- Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.
- Identify gaps and define needs to optimize publishing processes/tools that meet agency preferred specifications and CRR submission work.
- Identify molecule specific eCTDXpress publishing errors/issues and influence Regulatory Associates/authors/vendors/consultants to correct errors and coach to build capability for future submissions.
- Trouble shoot compile issues and proactively collaborate cross-functionally to resolve.
- Test new software updates and identify/report issues impacting publishing.
- Partner with quality to help determine root cause analysis of deviations.
- Facilitate efficient review of the registration by the regulatory agency.
- Ensure compliance submissions are delivered on time.
- Positively impact regulatory cross-functional initiatives through active participation in process improvement projects, drafting/reviewing RQS documents.
- Develop procedures and Job Aids for SME area.
- Initiates consultation with Regulatory Associates and Regulatory Scientists to share best practices and move towards more efficient/effective work processes.
- Perform quality review of peer’s submissions to ensure accuracy/compliance and coach to improve.
- Train new Submission Publishers.
- Conduct submission planning for assigned portfolio by identifying publishing milestone requirements for upcoming submissions and planning/managing workload to ensure on time submissions, proactively seeking resources when needed.
- Lead troubleshooting investigations for compile issues for assigned molecules.
- Coordinate and communicates with Regulatory Associates to prepare for unique requirements for the molecules and plan for upcoming submissions.
- Proactively review multiple document sites to assess timing of document readiness from upstream authors and work ahead to publish documents.
- Serve as a single point of contact for customers (e.g., Regulatory Associates, Regulatory Scientists, authors, cross functional stakeholders) for managing the submissions in eCTDXpress backbone.
- Identify, escalate, and resolve issues that may impact submissions.
- Collaborate with Regulatory Associate for submission bundling opportunities.
- Partner with other geographies to identify, understand, and incorporate EU and OUS agency regulations and county specific requirements to effectively influence the electronic registration plan.
- Develop collaborative relationships with personnel in other Lilly functional areas (e.g. DCoE/medical, RACMC, GOLD, Quality etc.).
- Manage numerous templates and working folders to keep accurate and up to date to maintain efficiency and accuracy
Minimum Qualification Requirements, Clinical Publisher Associate – eCTD:
The following skills and abilities are directly related to the essential functions of the job.
- Degree qualified in a related field
- Three years’ experience publishing submissions using eCTDXpress.
- Demonstrated project management and time management skills.
- Demonstrated organization and priority setting skills: must be able to manage diverse tasks and processes.
- Flexibility, ability to handle time pressures
- Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and customers.
- Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability
- High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
- Proficiency in SharePoint technology.
- Proven ability to take initiative and identify issues and solutions.
- General knowledge of scientific literature and library retrieval.
- Ability to work well independently and as part of a team, and ability to assertively marshal the efforts of multiple contributors to projects.