Bethany Williams

Work History

Certara

06.2023 - 06.2024

Served as a client lead, assessing studies of diverse phases, status, and investigator location against international disclosure laws and guidances and educating clients on the information to be disclosed dependent on the registry
Processed ClinicalTrials.gov and EudraCT registrations and results postings following international disclosure laws and client policy, under agreed timelines, and within agreed quality standards
Conducted quality-control review of registrations and results postings
Created and managed project plans, timelines and budgets.
Conducted thorough research to identify trends and inform decision-making for business growth initiatives.
Obtained a functional knowledge of redaction practices and tools and aided with multiple dossiers.

Certara

04.2020 - 06.2023

Collaborated with cross-functional teams to ensure timely completion of document-related tasks, enhancing overall project efficiency.
Took ownership of aspects of large and complex regulatory submission projects, using project management skills to deliver the project on time and within budget
Provided technical specialization skills in document formatting, regulatory operations, and project management while fully understanding their impact on a submission
Served as point of contact, consulting directly with clients
Served as SME for business development in regulatory operations
Oversaw performance of team of submission publishers, assigned resources and updated management on projects
Kept abreast of industry trends and best practices in regulatory submissions, continuously improving processes for maximum efficiency and compliance.
Authored a blog, 'Fixing Q-Submission Errors that Prevent FDA Acceptance of Medical Device Submissions', highlighting common errors that cause the failure of Q-Submissions to load to FDA's repository or cause an eCopy Hold, and identified means of avoiding these failures.

Certara

04.2019 - 03.2020

Consulted with clients to manage maintenance, milestone, and special request submissions
Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
Supported clients and mentored colleagues with submission and software-related questions
Supported regulatory submissions to the FDA and Health Canada
Published documents and tracked publishing progress for eCTD submissions according to company, industry, and client policies
Performed quality control review per company procedures to ensure documents have been prepared for submission in a compliant fashion
Transmitted electronic submissions via ESG to FDA and Health Canada.

Certara

12.2017 - 03.2019

Prepared and supported regulatory submissions to the FDA
Followed all company policies and procedures to deliver quality work.
Published documents by establishing navigation in submission files following company, industry, and client policies
Performed quality control review per company procedures, identifying, documenting, and remediating any findings
Transmitted electronic submissions via ESG to the FDA
Tracked document publishing progress for eCTD submissions by using company tracking tools.

G&W Laboratories

03.2015 - 12.2017

Coordinated documents (specifications, methods, protocols, reports, etc.) utilizing MS Word and Master Control/QUMAS (EDMS) in conjunction with change requests generated in Trackwise system
Assisted with migration of QC documents from Wisdom EDMS to Master Control EDMS and from Master Control EDMS to QUMAS EDMS
Coordinated standards in the LIMS/Labvantage system for use in QC Laboratory

Teva Pharmaceuticals

09.2002 - 03.2015

Managed USP and PF compliance projects and generated supporting documentation (protocols/reports)
Harmonized the format of Specifications and Analytical Procedures utilized in the QC laboratory and generated and revised documentation, respectively
Supported the resolution of EDMS issues and EDMS dictionary changes
Conducted analysis utilizing various instrumentation for technical projects in a cGMP and cGLP-compliant manner