Associate Director, Clinical Editing and Publishing

SHARON A. RAUSCH

*** ******** *****, ************, ** 19460

Mobile: 610-***-**** *************@*******.***

PROFESSIONAL Submissions management SUMMARY professional with proven record of accomplishing and delivering optimal results in high-growth environments through initiatives that exceed operational performance targets and yield measurable outcomes.

CORE QUALIFICATIONS Training and leadership development

Project planning and execution

Project management

Productivity and efficiency improvement

Quality control leadership

Multi-site operations

Problem solving

Communication and negotiations

Customer satisfaction

Team building coordination/training

EXPERIENCE Associate Director/Clinical Editing & Publishing, Shire Pharmaceuticals, Wayne, PA 2011 - Present Technical Editing Manager

Senior Technical Editor

Build and harmonize a clinical editing and publishing team to support clinical submissions for medical writing.

Develop and lead multi-site medical writing efforts to establish a cohesive streamlined process for editors, publishers, and medical writers.

Work closely with authors to develop timelines, resources, and submission deliverables.

Evaluate trends to identify, develop, and implement technology improvements for quality and efficiency.

Lead harmonization of standards between sites to increase efficiency.

Reduce timeline deliveries by 50% on clinical quality control (QC) and editing within the department.

Reduce manual clinical publishing tasks by incorporating steps for clinical editing submission-ready standards.

Redesign a scheduling system for ongoing and fluctuating timelines for clinical editors and clinical publishers.

Manage the clinical editing and publishing assignments, timelines, and resource requirements for clinical documents and regulatory submissions within medical writing.

Manage, mentor, and provide direction to clinical editing and publishing direct reports and contractors.

Ensure resources (e.g., headcount, funding, time) are appropriately represented to relevant teams and management.

Identify and recruit high-level candidates for open positions in medical writing, clinical editing, and clinical publishing.

Oversee external third party vendors as necessary.

Provide high quality QC content review of clinical documents (e.g., clinical study reports, investigator’s brochures, submission summaries, and protocols) maintaining tight timelines.

Ensure production of documents comply with company SOPs/styles and regulatory guidances.

Provide submission management expertise for electronic document management, submission compilation, publishing, and management of approval information.

Lead regulatory submission-ready standards task force for cross-functional consistency.

Increase efficiencies within the electronic document management system.

Lead working group members for preparing, testing, and rollout of company system upgrades.

Identify needs and execute supplemental training for clinical editing and publishing.

Oversee tracking and delivery of quality document reviews to authors.

Prepare and maintain clinical editing metrics for year-end reporting. Regulatory Submission Specialist/

Senior Technical Editor, Synchrogenix Information Strategies, Malvern, PA 2010 – 2011

Edited and performed QC checks of pre-clinical and clinical documents intended for submission to regulatory agencies

(protocols, amendments, clinical study reports, investigator brochures, clinical submission summaries). SHARON A. RAUSCH

Provided submission management expertise for electronic document management, submission compilation, publishing, and management of approval information.

Increased profitability by offering regulatory publishing services to multiple clients.

Reduced project timelines by training document specialists in regulatory publishing.

Identified potential risks and provided strategies to manage risks.

Communicated to the global regulatory project leader and global regulatory project team requirements and issues to be considered and contribute to achieving realistic timelines.

Collected necessary information from the project team and planned all submission management-related activities.

Identified resource needs for assigned submissions and liaise with management to secure the required resources.

Assisted in eCTD/eNDA/eIND submission publishing.

Managed timelines for publishing activities to ensure reviews of submissions were completed in a timely manner.

Managed project staffing across multiple submissions and clients.

Managed vendors and tools.

Identified and recruited high-level candidates for open positions.

Provided expert support for publishing tools, ISIToolbox, and Adobe Acrobat.

Communicated timelines and specifications to clients and interacted with all functional areas to ensure regulatory compliant submissions and adherence to business critical processes and procedures.

Trained and developed personnel within regulatory affairs across all functions to produce electronic submission-compliant deliverables.

Managed regulatory operations/information management initiatives including data standards implementation, electronic document management, publishing software and ISIToolbox upgrades, Acrobat upgrades, and other projects based on the information management roadmap.

Senior Technical Editor/Medical Writing, sanofi-aventis, Malvern, PA 2000 – 2010

Managed technical editors, document specialists, and contract personnel.

Ensured high-quality editing, QC, formatting, proofreading, bookmarking, and hypertext linking of documents for electronic submission to FDA within a documentum environment.

Managed and delivered Module 2 and Module 5 summary documents for regulatory submissions.

Coordinated, edited, and reviewed regulatory submission documents from creation to approval on strict deadlines.

Led clinical publishing efforts for document-level publishing and full study report publishing within Documentum and using Core Dossier.

Collaborated with Regulatory Operations for publishing activities, including participation in process improvements for publishing efforts between Clinical and Regulatory.

Reduced publishing timelines by initiating new processes for faster deliverables.

Developed initial drafts for Clinical Study Reports, tabular formats, and summary documents.

Participated in regulatory project teams to prepare electronic table of contents (eTOC) for eCTD submission.

Provided planning support to regulatory operations in delivery of high-level submission documents.

Optimized the process for preparing electronic navigation more efficiently.

Achieved shorter delivery times with process improvement.

Identified and recruited high-level candidates for open positions.

Directed departmental “help desk” for troubleshooting electronic files.

Coordinated company-wide presentations for introduction of new training programs.

Trained clinical employees on document templates, documentum, and company process.

Actively participated in company-wide software and template updates.

Developed and implemented training manuals departmentally and worldwide, assisted in development of SOPs, process improvement, and infrastructure improvements.

Ensured training to stay current with changes and improvements to documentation system.

Received ISI Toolbox certification for publishing activities.

Received excellence awards for outstanding performance. OTHER Drug Information Association (DIA) member

American Medical Writers Association (AMWA) member Good Clinical Practice (GCP) certified – CITI program

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