Danielle Murray Email & Phone Number

Philadelphia, Pa, Us

Philadelphia, Pa, Us

Rahway, New Jersey, Us

Rahway, New Jersey, Us

Rahway, New Jersey, Us

Rahway, New Jersey, Us

Rahway, New Jersey, Us

•Regulatory liaison responsible for diabetes investigational drug clinical trial submissions worldwide. Supported both internal and outsources studies. Provide global regulatory support for clinical trial application activity, including Phase 1 through Phase 3 clinical trials. This includes managing agency questions and responses, providing regulatory strategy and participating in cross functional teams to ensure information is communicated appropriately. • Support emerging market/secondary market filings, providing global regulatory support and strategy for the coordination, release, and approval of new product registrations, and modification of existing registrations for Merck products worldwide. • Provide regulatory input for safety label changes, risk management plans, PSUR’s and DSUR’s and clinical evaluation reports for medical devices.• Support lifecycle management phase of assigned products and assume responsibility of all regulatory issues for in-line (mature) products. • Collaborate and communicate cross-functionally with Clinical, CMC, labeling, global clinical supplies, worldwide product labeling and international subsidiary personnel on a regular basis to ensure robust and timely communication and for issue escalation.

Rahway, New Jersey, Us

Hepatitis B Vaccine Support• Support multiple assay investigations. • Partnered with statisticcal group to design experiments to support method changes. Performed all assay development work, authored developmental report, authored and executed assay validation and concordance study. Critically analyzed data. Authored the assay validation report and provided analytical support to regulatory team in support of notification of the change.• Managed direct report to support the assay development, validation and concordance for three Hepatitis B intermediate assays.• Analytical representative on cross functional team. • Established strategy for mouse potency testing for Hepatits B vaccine.• Support analytical issues worldwide for alum containing vaccines as single point of contact including Japan, Haarlem, South Korea and Elkton. Multivalent Vaccine Support• Led the efforts to quickly develop and validate a new method (Content Uniformity) in support filing in Japan. Provided guidance to direct report for feasibility experiments, authoring pre and formal validation protocols and reports. Reviewed and approved all data from experiments. • Led weekly teleconference with Japan in support of two new methods. This included quickly resolving analytical issues, shipping samples and instruments internationally as well as critical reagents.•Provided analytical support to regulatory team by drafting the assay validation sections for the license, and answering technical questions in preparation for PMDA visit.Multivalent Bacterial Vaccine Support•In response to a regulatory commitment, managed the transfer of the phenol assay worldwide (approximately 5 countries).•Provided analytical support to regulatory team to support the update.

Rahway, New Jersey, Us

• Managed the validation and implementation of all release methods required for multi valent vaccine•Technical lead for release assay transfers worldwide in support vaccine registration as well as shipping and logistics to all markets.• Analytical sub-team lead for release assay transfers to Merck satellite sites for multi valent vaccine process validation. Authored 15 transfer protocols, coordinated all testing, performed statistical analysis, provided troubleshooting assistance as needed and authored reports.• Experienced in troubleshooting multiple analytical methods across Merck satellite sites.• Lead the concordance study for the manual and automated (Tecan) immunoassays for multivalent vaccine. • Coordinated the immunoassay transfer to Merck sattelite site (ex-US) including technical support, troubleshooting and sample distribution. •Co-lead for the analytical sub-team to track all analytical issues related to the program.

Rahway, New Jersey, Us

Analytical Automation and Implementation Project• Coordinated the arrival and set-up of the automated system, which was new technology the division, as well as the renovations to the laboratory.• Coordinated and finalized the IQ/OQ documents and obtained alignment between all functional areas for approval.• Successfully executed the IQ/OQ/PQ on two automated systems.• Successfully trained multiple analysts on the instrument. • Generated a working timeline for the method transfer from from research to manufacturing.