Linda Miranda

Assign projects for advertising and promotion submissions.

• Review completed submissions
• Respond to client inquiries
• Provide reports and data to the corresponding managers.
• Submitted project deliverables to clients, consistently adhering to quality standards.
• Collaborated with cross-functional teams to define requirements for new initiatives.
• Troubleshot and resolved non-technical issues using support documentation and training.
• Prioritized needs and delegated assignments to simultaneously handle multiple projects.
• Archive submissions.

• Provided support and guidance to colleagues to maintain a collaborative work environment.
• Assisted with customer requests and answered questions to improve satisfaction.
• Completed day-to-day duties accurately and efficiently.

• Provide formatting assistance, update cover letters, upload files to publisher
• Review formatted documents and published output

• Independently prepares and send submission filings to health agencies
• Provide project management mainly for NDA and IND submissions including Promotional Material and Canadian submissions
• Was the publishing lead for an IND
• Provides support for complex filings
• Responsible for up to 6 products consecutively, either in research stage or on market
• Support Regulatory Affairs with questions regarding eCTD, template support, formatting, technical assistance
• Attend meetings to support/answer questions related to publishing and formatting
• Generate guidelines and instructional information for the team and regulatory affairs
• Work with regulatory operations and regulatory affairs stakeholders to establish best practices
• Supports formatting team by formatting reports, protocols, meeting requests and meeting packages, investigator brochures, clinical documents by applying Emergent standards to MS Word documents and PDF’s
• Assist document authors

• Ensure the success of key biopharmaceutical commercialization documentation, providing operational management and execution across all documentation and submission processes
• Control the full suite of filing and submission for up to three products during research and market stages
• Designed and implemented a tickler-reminder system, securing noticeable improvements in project phase progression and timeline adherence
• Personally selected to participate in a key Health Canada submission project in collaboration with six other teammates on the basis of a proven ability to quickly obtain detailed, thorough expertise on new subject matter and processes
• Cultivated expertise in formatting, publishing, transmitting, and archiving all submission documents, fact- and error-checking documents to ensure precise accuracy
• Leverage thorough expertise on State and Federal filing requirements to monitor submission processes for procedural compliance
• Recruited from temporary position to permanent employee within one month of employment and trained by the company in paid eCTD software processes
• Earned numerous merit-based raises and bonuses, as well as high-praise supervisor reviews
• Nominated for and won more than 20 internal commendation awards Building the BioMarin Community, Integrity, Collaboration, and Going the Extra Mile, recognizing an exceptional dedication, performance, and willingness to rise to challenges and business/team needs

• Executed vital administrative functions to drive continuous operational success
• Received, processed, and prepared prequalification and insurance certificate information to produce competitive bids for projects
• Monitored and maintained accurate payroll operations
• Created in-document analysis and comparison of printing bond plots to optimize cost efficiency
• Leveraged robust documentation to negotiate in-house printing prices, securing notable cost reduction for key services

• Delivered critical administrative and operational support, leveraging robust knowledge of business needs and operations to maintain optimal function of Clinical Operations team and office
• Supported teamwide efforts across all administrative assistants and up to six clinical researchers
• Produced detailed meeting minutes, generated complex marketing-material tracking spreadsheets, and authored reports and communications, sharing documentation with relevant parties
• Maintained department library, ensuring easy accessibility in filing and tracking systems
• Coordinated team, office, and executive schedules, orchestrating staff events and meetings and arranging executive travel itineraries
• Received commendation for exceptional dedication and performance, including a recommendation for continuing employment following the end of the temporary position