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Lab Assistant Manager Marketing Associate Junior Project Manager Resume Example

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JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Summary

Self-motivated Regulatory Affairs Associate with leadership experience and a drive to constantly increase efficiency and effectiveness of procedures. Equips teammates to meet goals by working to build a collaborative and skill-based culture. Focused on delivering decisive, forward-thinking and positive leadership to enable success while maintaining strict quality standards.

Skills

Leadership

  • Experience managing and motivating teams of 15+ people as well as directing more focused project teams.
  • Experienced in providing feedback on performance and creating action plans for improvement or development.

Process Automation/Efficiency

  • Proficient in automating basic business processes using Microsoft Automation, Sharepoint, and Teams to improve team efficiency.

Time Management

  • Experienced in maintaining timelines for multiple projects in different subject areas while sustaining the quality of daily work.

Communication

  • Able to translate complex text and ideas into easily readable material matched for a target audience.

Data Analysis

  • Data gathering and processing. Skills in some advanced data organization and use of formulas connecting multiple spreadsheets in Excel.

German

  • Conversational spoken. Limited working proficiency. Some skills in reading and writing.
Experience
03/2016 to 03/2017 Lab Assistant/Manager, Marketing Associate, Junior Project Manager Tapestry, Inc. | Nanuet, NY,
  • As lab manager, maintained stock and organization of multiple laboratory areas and ensured proper calibration and maintenance of all equipment.
  • Assisted marketing team in preparing for conferences and events, as well as in reviewing literature and compiling contact databases for future use.
  • Served as junior project manager for new product launches and oversaw the development and implementation of a new quality control document system.
  • Assisted work with pharmaceutical division, including placing orders and receiving import and export permits for shipments.
  • Assisted in research projects and lab work as required by multiple research teams.
03/2017 to 01/2019 Quality Complaints Specialist I-II West Pharmaceutical Services | Remote, OR,
  • Reviewed and evaluated complaints according to standard operating procedures and submitted corresponding medical device reports to relevant authorities.
  • Assisted with documentation and maintenance of records of all complaint investigations in accordance with domestic and international regulations
  • Designed and completed projects with a focus on increasing processing efficiencies and maintaining consistency in Medical Device Reports.
  • Joined the Customer Advocacy Sharepoint team. Helped to create and maintain content covering system efficiencies, international reporting resources, and general department news.
  • Lead effort to increase communication with FFA lab to improve consistency of complaint investigations on audio related issues.
  • Actively worked with the focus group dedicated to the improvement of the new complaint handling system, including gathering input from individual specialists and researching all known system issues. Helped create the System Errors and Workarounds notebook and assign severity values to current issues based on feedback.
  • Assisted with management of international writing team and running of daily and weekly reports to ensure on time reporting
01/2019 to 06/2019 Interim Supervisor Dexcom Inc | City, STATE,
  • Managed a diverse group of 15 specialists working on a variety of complaint categories relating to multiple product lines.
    Ensured on-time and accurate reporting of complaints to regulatory authorities.
  • Created day-to-day and long term strategies for the team to ensure all projects were completed in a timely manner. Maintained close communication with team to address issues and redistribute work quickly when necessary.
  • Worked to promote individual development opportunities for specialists both within and outside of the department.
    Performed one on one reviews with specialists on a monthly basis to assess progress on goals and identify areas for improvement.
  • Worked as an effective liaison between the field failure analysis lab and customer advocacy to expand product knowledge and increase the consistency of product investigations on any returned product.
  • Trained specialists in new processes in two separate complaint handling systems and reviewed work to ensure accurate reporting.
  • Led project to redesign the Medical Device Report template to reduce the potential for error and increase consistency between specialists.
    Designed and presented a training program to allow for an effective roll-out of the new writing process.
  • Took up a position as a subject matter expert and fielded emails regarding edge-case complaint processing scenarios and requests for verbiage approval in FDA submissions.
  • Assisted with the interview and review of potential new specialists.
06/2019 to Current Associate Specialist, Regulatory Affairs Dexcom Inc. | City, STATE,
  • Coordinated and prepared document packages for regulatory submissions for new and mature products to ensure compliance with domestic and international regulations.
  • Compiled materials required for international license renewal and annual registrations.
  • Distributed change orders requiring regulatory approval or assessment and followed up to ensure timely completion.
  • Implemented new automated methods for tracking of regulatory operations tasks and for the control of regulatory submissions and internal documents.
  • Tracked and reported monthly metrics for the regulatory affairs department. Assisted in developing new methods of data gathering and metrics presentation to improve the completion time of data requests.
  • Organized budget documentation and tracked expenses across multiple teams. Created new purchase orders based on department needs and ensured on-time payment of invoices to suppliers and regulatory authorities.
  • Participated in the review and development of promotional and labeling material from a Regulatory perspective.
  • Kept up-to-date with changes in regulatory legislation and guidelines and distributed updated guidance documents to teams as necessary.
Education and Training
Expected in 2016 Bachelor Of Science | Microbiology University of California - San Diego, La Jolla, CA GPA:

Coursework in Microbiology, Cell Biology, Molecular Biology, Marine Microbiology, and some Physiology. Practical coursework introducing laboratory skills including Western Blotting, Protein Purification, Cell Culture, Tissue
Culture, ELISA, Binding Assays, DNA extraction Polymerase Chain Reaction (PCR), Pipetting. Elective coursework including German language study and German Literature.

  • Member of Alpha Chi Omega
  • Member of Equestrian Team 2009-2011
Certifications
  • Certified Notary of the State of California

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Resume Overview

School Attended
  • University of California - San Diego
Job Titles Held:
  • Lab Assistant/Manager, Marketing Associate, Junior Project Manager
  • Quality Complaints Specialist I-II
  • Interim Supervisor
  • Associate Specialist, Regulatory Affairs
Degrees
  • Bachelor Of Science