Danielle Phillips

Position Department(s): Regulatory Procedures & Processes (RPP): Digital Innovation & Systems (DIS)

Generalized duties:

• Oversaw various tools and systems used by the RPP.
• Understand the tools utilized by RPP, use the Global Regulatory Affairs and Clinical Safety (GRACS) Digital Strategy, including the new tools, and work towards more cohesive, timely data.
• Work closely with the DIS Associate Directors, Innovation & Information Management (IIM), and Information Technology (IT) Project Leads for various projects.
• Assist with tool development and/or modifications.
• Led training sessions to enhance team understanding of regulatory requirements. cross-tool, business process connections. and best practices.
• Serve a key role in ensuring that change management, including communications and training, is available to the RPP team as each aspect of the Digital Strategy is rolled out.
• Assist in maintaining RPP Digital Tools, such as SharePoint, Sync Page, and Data Entry Request forms, in platforms such as Power BI.
• Mentor and coach RPP personnel impacted by tool or business process changes on the concepts, methods, and nuances of the changes.
• Utilize the company-wide network, appropriate methodologies, and tools at the appropriate level of rigor to solve problems.
• Implemented process improvements that reduced turnaround time for data reporting tasks.
• Facilitated cross-functional meetings to align project objectives with organizational goals.
• Maximized efficiency within teams by establishing clear procedures for task delegation and progress tracking related to data initiatives.
• Ensured timely completion of projects by efficiently coordinating cross-functional teams involved in data management activities.
• Facilitated communication between departments, ensuring alignment of data-related objectives and strategies.
• Ensured compliance with industry standards and regulations regarding sensitive information handling protocols, maintaining strict confidentiality where necessary.
• Developed comprehensive documentation to facilitate a seamless transfer of knowledge among team members and stakeholders.
• Utilized established methods for data processing and analysis for consistency and accuracy.
• Identified data errors and discrepancies and implemented swift corrections.
• Assisted and monitored the development of data entry procedures to streamline data processing.
• Generated detailed reports from collected data to inform stakeholders.
• Collaborated with other departments to enforce data accuracy and enhance productivity.
• Analyzed changes in regulations and communicated updates to relevant stakeholders effectively.
• Conducted thorough risk assessments to identify potential compliance issues in product development processes.
• Enhanced regulatory compliance by developing and implementing robust policies and procedures.
• Conducted thorough risk assessments to identify potential compliance issues and develop effective mitigation strategies.
• Coordinated responses to inquiries from regulators, demonstrating commitment to transparency and cooperation.
• Provided expert guidance on regulatory requirements, supporting the development of compliant products and services.
• Optimized internal audit processes, identifying areas for improvement in regulatory adherence.
• Strengthened relationships with regulatory authorities through transparent communication and proactive engagement.
• Established a strong culture of compliance throughout the organization by promoting awareness and accountability at all levels.
• Managed complex regulatory projects, ensuring timely completion and optimal outcomes.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Recommended improvements to processes.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Worked with governance committees to make and evaluate plans.
• Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
• Developed or tracked quality metrics.
• Authored or updated standard operating procedures, work instructions or policies.
• Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

Article 46 monitoring duties:

• Responsible for Article 46 compliance monitoring, which entailed systematic oversight of indicator fields within the registration management system. Duties included tracking submission due dates, issuing timely reminders to designated personnel, and collecting compliance metrics for reporting to the compliance council.
• Generated and analyzed monthly reports from the registration management system to identify protocols with missing field entries, and those with imminent submission deadlines. Responsible contacts were identified, and all queries to central and regional planners were reconciled, with any necessary updates applied within the system.
• Proactively provided submission reminders to planners at 30 and 60 days prior to due dates, ensuring that all parties involved were informed and prepared for timely submission.
• Maintained a record of 100% on-time compliance with submission due dates throughout my tenure in this role.

Health Authority Commitment duties:

• Managed Health Authority (HA) commitments within the Health Management System (HMS) from creation to closeout.
• Oversaw compliance with regulatory requirements in data management practices and documentation.
• Utilized the Food and Drug Administration (FDA) website to quality-check against HMS.
• Posted post marketing requirements to the Transparency page for public consumption.
• Prepared quarterly metrics for the Commitment space for approval by Therapeutic Leads and Heads of Quality Compliance groups.
• Authored multiple execution resources for the Commitment space, as well as working guidelines for all data entry into the HMS.
• Maintained a record of 100% quality compliance with the FDA against the HMS.

Study Site Document Retention Request Duties:

• Managed data entry processes to ensure accuracy and efficiency across multiple projects.
• Determined registration approval or withdrawal dates for studies conducted in International Council for Harmonization (ICH) countries, and assessed the status of investigative applications to ensure compliance with regulatory requirements prior to authorizing document disposition.
• Respond to retention requests submitted by study sites regarding document destruction approval by retrieving and verifying relevant data from the registration management and submission archive systems.
• Coordinated interdepartmental communication to streamline data flow and enhance collaboration.
• Developed and maintained data management systems, improving accessibility for team members.
• Led training sessions for new staff on data handling procedures and best practices.
• Analyzed data trends to support strategic decision-making within research initiatives.

Position Department(s): RPP

• Process/Resolve data/system issues for Global Product Registration Management database used for tracking pharmaceutical, biological, and vaccine registration information and supplemental variations with regulatory agencies worldwide to facilitate release of product to all markets.
• Assist in the development, planning, implementation, and execution of day-to-day operations.
• Provide assistance and direct support of the implementation and continual assessment of an optimized submission manufacturing strategy.
• Perform duties in a fast-paced environment on the critical path to timely Worldwide Marketing Applications.
• Review, process, and approve system users' requests for data addition/deletion/modifications; respond to users' e-mail inquiries regarding business processes, data, and systems.
• Manage MS SharePoint team site, use MS Office.
• Utilize RCAM electronic document system to find supporting documents.
• Maintain GMP change control documentation.
• Use professional oral and written communication skills.
• Strong analytical and customer service skills with the ability to work with varying grade levels, educational backgrounds, and departments in a team environment.
• Excellent communication skills.
• Demonstrated ability to work under tight and changing deadlines.
• Proven attention to detail and an ability to work with a variety of technical applications.
• Mentored junior marketing staff, fostering professional development and enhancing team performance.
• Established key performance indicators to measure campaign effectiveness, continuously improving strategies based on data analysis.
• Managed a team of marketing professionals, resulting in increased productivity and project success rates.
• Streamlined internal communication processes within the department, improving overall efficiency and project completion times.
• Maintained documentation, detailing assignments, in-progress work and completed project milestones.

Position Department(s): Chemistry, Manufacturing and Control (CMC)

• Process and resolve data and system issues for the Global Product Registration Management database, which is used for tracking pharmaceutical, biological, and vaccine registration information, as well as supplemental variations with regulatory agencies worldwide, to facilitate the release of products to all markets.
• Assist in the development, planning, implementation, and execution of day-to-day operations.
• Provide assistance and direct support for the implementation and continual assessment of an optimized submission manufacturing strategy.
• Perform duties in a fast-paced environment on the critical path to timely, Worldwide Marketing Applications.
• System administrator for the ORION database (Liquent INSIGHT) at Merck.
• Review, process, and approve system users' requests for data addition, deletion, and modifications; respond to users' email inquiries regarding business processes, data, and systems.
• Manage MS SharePoint Team Site and use MS Office.
• Utilize the Documentum electronic document system to maintain GMP documents.
• Support teams working on migration-related activities for the harmonization of multiple regulatory databases.
• Maintain GMP change control documentation.
• Use professional oral and written communication skills.
• Strong analytical and customer service skills, with the ability to work with varying grade levels, educational backgrounds, and departments in a team environment.
• Excellent communication skills.
• Demonstrated ability to work under tight, changing deadlines.
• Proven attention to detail, and an ability to work with a variety of technical applications.
• Gathered, organized and input information into digital database.
• Streamlined operational processes, enhancing efficiency and reducing downtime across multiple departments.
• Collaborated with cross-functional teams to improve project outcomes, ensuring alignment with organizational goals.
• Oversaw day-to-day operations, delegating tasks appropriately to ensure smooth workflow and timely completion of projects.
• Collected, arranged, and input information into database system.
• Implemented necessary changes in response to shifting business needs, maintaining a proactive approach to problem-solving.
• Continuously sought opportunities for professional development in order to remain knowledgeable about industry best practices.
• Fostered culture of continuous improvement by encouraging feedback and innovative ideas from all team members.

Position Department(s): Quality Assurance (QA) Microbiology

• Process and resolve data and system issues for The Global Specification System, which is the official repository for technical specifications and procedures in the Johnson & Johnson Consumer organization.
• System Administrator for GSS Database.
• Manage MS SharePoint Team Site, and use MS Office.
• Utilize the GSS electronic document system to maintain GMP documents.
• Maintain a type of IT help desk for GSS.
• Use the Symphony ETQ database to log IT issues.
• Support the global document management processes and remediation activities for the Global Specification System (GSS).
• Review, process, and approve system users' requests for data addition, deletion, and modifications; respond to users' email inquiries regarding business processes, data, and systems.
• Support a web-based, database-driven software application used within the consumer sector of pharmaceuticals for the creation, modification, review, approval, and distribution of electronic specifications and procedural documents.
• Partner with a team comprised of members from the GSS Application Business Support group, the GSS Application IT Support group, and Computer System Validation Quality Assurance to drive the completion of the GMP investigations, identified corrections, corrective actions, preventive actions, audit commitments, and other system and process remediation activities.
• Communicate with GSS leadership regarding the status of the deliverables.
• Participate in the prioritization of remediation activities for GSS, and regularly communicate with GSS leadership on the status of these activities.
• Provide ongoing support to the existing regional Document Management Process within the Consumer Sector, and lead harmonization activities to implement a global process.
• Developed and maintained document control systems to ensure compliance with regulatory standards.
• Streamlined document workflows, improving retrieval times and reducing processing delays.

Position Department(s): CMC

• Process and resolve data and system issues for the Global Product Registration Management database, which is used for tracking pharmaceutical, biological, and vaccine registration information, as well as supplemental variations with regulatory agencies worldwide, to facilitate the release of products to all markets.
• Execute validation test scripts.
• System administrator for the ORION database (Liquent INSIGHT) at Merck.
• Review, process, and approve system users' requests for data addition, deletion, and modifications; respond to users' email inquiries regarding business processes, data, and systems.
• Manage MS SharePoint Team Site, and use MS Office.
• Utilize the Documentum electronic document system to maintain GMP documents.
• Support teams working on migration-related activities for the harmonization of multiple regulatory databases.
• Maintain GMP change control documentation.
• Use professional oral and written communication skills.
• Analyzed business processes to identify inefficiencies and recommend improvements.
• Collaborated with cross-functional teams to gather requirements for system enhancements.
• Actively participated in team meetings to share knowledge, exchange ideas, address challenges, and collaborate on potential solutions.
• Optimized workflow processes to enhance overall productivity and achieve operational excellence.
• Collaborated closely with stakeholders to identify opportunities for process improvements and drive continuous innovation in the organization.

Position Department(s): Data Management

• Assisted in preparing or updating departmental standard operating procedures (SOPs) related to data management.
• Trained associates in data management procedures and systems.
• Ensured study quality, provided document control, and oversaw data quality.
• Prepare and update clinical data management study-level documents, including but not limited to Data Management Plans, Data Entry Guidelines, Edit Check Specifications, Self-Evident Changes, notes to file, SAE Reconciliation Plans, and other documents.
• Tested new processes, databases, and systems for the management of clinical trials.
• Review and design case report forms in conjunction with the primary study statistical programmer and the study database administrator.
• Provided status reporting, issue and problem identification, and recommendations for resolution to IT management.
• Tested the database for validation and compliance with 21 CFR Part 11.
• Review statistical analysis plans.
• Assisted in preparing change controls, implementing their review, getting the proper approval for them, and closing them using the correct database.
• Ensured change controls were in compliance with documentation and guidelines, as well as implemented them with team member assistance, as needed.
• Ensured routine data management activities and deliverables were implemented and maintained, including data inflow, medical coding, external data coordination, and conversion, uploading, extraction, access, and data transfer.
• Provided responses, corrective actions, and audit reports, as well as other quality initiatives.
• Tracked data management, studied performance, and provided project tracking reports upon routine or ad hoc requests.
• Assisted in the contract, budget, and expense tracking related to data management at the study level.
• Created CRFs in appropriate design software that incorporates required data fields, as identified by the protocol, and/or by the Project team, and/or by the Sponsor.
• Created CRFs for Oracle Clinical (OC) studies with heightened attention to standardization for clinical, data management, and statistical implications, clarity (ease of completion), and legibility (aesthetics).
• Tracked all versions of the CRFs from the initial draft to the final. Save versions under the appropriate file-naming conventions within the study CRF directory.
• Understand protocols and provide feedback to the project team on design issues with regard to the protocol requirements, including translations, licenses, and validated tools.
• Maintained a historical library of CRFs.
• Oversaw data integrity and quality control processes across multiple databases.
• Developed and implemented data management strategies to enhance operational efficiency.
• Collaborated with cross-functional teams to align data practices with organizational goals.
• Led initiatives to automate data collection and reporting, reducing manual entry errors.
• Trained and mentored junior staff on data governance best practices and tools.
• Established protocols for data security compliance and risk management within the organization.
• Managed vendor relationships to optimize software systems used for data analytics and storage.
• Reviewed source documents and listings to compile resources for identifying and correcting data allocation issues.
• Trained team members in best practices for data handling, improving overall productivity and data integrity.
• Collaborated with cross-functional teams to identify data requirements and ensure proper integration within the system.
• Enhanced data accuracy by implementing robust data validation and quality control processes.
• Streamlined data management workflows for increased efficiency and reduced processing time.
• Partnered with subject matter experts in continuous improvement process, upgraded data quality and recommended innovative information management strategies.
• Provided expert guidance on regulatory compliance matters related to data storage, usage, and disposal.
• Spearheaded initiatives to automate repetitive tasks, freeing up staff time for more value-added activities.
• Troubleshot technical issues efficiently under pressure; provided prompt and knowledgeable support to end-users.
• Devised and implemented reliable data management procedures to enable usability and security of company data.
• Oversaw development of centralized data management platform, centralizing data access and enhancing collaboration.
• Reduced data retrieval times by implementing more efficient indexing strategies.