Experience

Facet Life Sciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Strategic Program Champion

  • Oct 2021 - Present

  Explore aggressive and innovative regulatory strategies and contingencies for investigational, new, or modified medical products to maximize the potential success of clients' medical product development programs. Provide expert scientific and regulatory guidance to clients throughout the development lifecycle of their products from pre-clinical through marketed product stages. Provide senior level review and oversight in the preparation of INDs, marketing applications (NDA/BLA), and… Show more Explore aggressive and innovative regulatory strategies and contingencies for investigational, new, or modified medical products to maximize the potential success of clients' medical product development programs. Provide expert scientific and regulatory guidance to clients throughout the development lifecycle of their products from pre-clinical through marketed product stages. Provide senior level review and oversight in the preparation of INDs, marketing applications (NDA/BLA), and other regulatory communications (e.g. FDA meetings, responses to information requests, etc.).

• Product Development Champion

  • Apr 2017 - Oct 2021

  Raleigh-Durham, North Carolina Area



Mercer Regulatory LLC

• Owner

  • Feb 2017 - Apr 2017

  Raleigh-Durham, North Carolina Area I provide strategic regulatory and medical writing service to the pharmaceutical industry. You can leverage my experience in pharmaceutical regulatory strategy and medical/regulatory writing to ensure success for your next FDA submission. I have in-depth experience developing regulatory strategy, organizing major submissions, and authoring a regulatory submission documents. Some areas of specialized experience that I draw on are: • 505(b)(2) submissions • Authoring IND and… Show more I provide strategic regulatory and medical writing service to the pharmaceutical industry. You can leverage my experience in pharmaceutical regulatory strategy and medical/regulatory writing to ensure success for your next FDA submission. I have in-depth experience developing regulatory strategy, organizing major submissions, and authoring a regulatory submission documents. Some areas of specialized experience that I draw on are: • 505(b)(2) submissions • Authoring IND and NDA submission documents, including CTD summaries (Modules 2.5 and 2.7), Clinical Study Reports, and Investigator Brochures • Authoring draft Prescribing Information (USPI) for NDA submission • Communication with FDA including preparation and authoring of briefing documents and responses to Agency questions • Preparation of routine IND and NDA maintenance documents (e.g. Annual reports, DSURs, etc.) • Organization and project management for large submissions • Abuse-deterrent opioid strategy • Pediatric submissions, including Written Request responses and PREA studies Contact me to discuss how I can help you succeed with your next FDA submission. jmercer21@att.net Show less



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Aug 2013 - Sep 2016

  Provide regulatory strategy and support for the development of branded drug products primarily within the pain management therapeutic area, including both oral and intravenous doasge forms. Key responsibilities include interaction with the US FDA, participation in cross-functional teams for design of clinical studies and preparation of regulatory documentation for INDs and NDAs with a focus on strategic content communication for optimum outcome. Specialized areas of interest… Show more Provide regulatory strategy and support for the development of branded drug products primarily within the pain management therapeutic area, including both oral and intravenous doasge forms. Key responsibilities include interaction with the US FDA, participation in cross-functional teams for design of clinical studies and preparation of regulatory documentation for INDs and NDAs with a focus on strategic content communication for optimum outcome. Specialized areas of interest include: 505(b)(2) strategy Pediatric commitments (PREA and BPCA requirements) Integration management Abuse deterrent opioids Show less



Merz Aesthetics

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Jun 2009 - Aug 2013

  Contribute to international project teams and provide US regulatory support for development programs. Lead planning, management, and execution of regulatory submissions: FDA liason for projects spanning the product development spectrum from pre-IND through NDA/BLA approval. Coordinate project team preparation for FDA meetings Preparation of regulatory submissions including IND amendments, and marketing applications (NDA and BLA) Provide regulatory intelligence to company… Show more Contribute to international project teams and provide US regulatory support for development programs. Lead planning, management, and execution of regulatory submissions: FDA liason for projects spanning the product development spectrum from pre-IND through NDA/BLA approval. Coordinate project team preparation for FDA meetings Preparation of regulatory submissions including IND amendments, and marketing applications (NDA and BLA) Provide regulatory intelligence to company management to help shape product development strategy. Show less



National Institute of Environmental Health Sciences (NIEHS)

• United States
• Research Services
• 500 - 600 Employee

• IRTA Postdoctoral Fellow

  • Apr 2005 - Jun 2009

  Postdoctoral research examining store-operated calcium entry. I am primarily interested in the role and regulation of store-operated calcium entry in neutrophils. In this position, I have been instrumental in the characterization of two new proteins involved in the store-operated calcium entry pathway. (see Mercer et.al J. Biol. Chem.(2006) vol.281, 24979-90). Recently I have developed lentiviral vectors to deliver shRNA or cDNA into HL-60 promyelocytic leukemia cells in order to… Show more Postdoctoral research examining store-operated calcium entry. I am primarily interested in the role and regulation of store-operated calcium entry in neutrophils. In this position, I have been instrumental in the characterization of two new proteins involved in the store-operated calcium entry pathway. (see Mercer et.al J. Biol. Chem.(2006) vol.281, 24979-90). Recently I have developed lentiviral vectors to deliver shRNA or cDNA into HL-60 promyelocytic leukemia cells in order to study the role of the store-operated calcium entry pathway in neutrophil function. Show less



Campbell University

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Instructor - Biology

  • 2007 - 2009

  Responsible for intitial science program setup at Campbell's RTP satellite campus. Planned for necessary equipment orders, suggested possible course offerings, and taught courses in introductory biology, cell biology, and forensic science.



Penn State University

• United States
• Higher Education
• 700 & Above Employee

• Graduate student

  • Aug 2000 - Apr 2005

  PhD student in the Biochemistry and Molecular Biology department. My doctoral dissertation work was performed under the supervision of Dr. Avery August. My primary project involved the characterization of an immuno-suppressive compound known as BTP2. As a graduate student I participated in studies examining the cell signaling events that are activated following T cell receptor stimulation of CD4+ T helper cells. In this role I became proficient at many cell signaling assays such as… Show more PhD student in the Biochemistry and Molecular Biology department. My doctoral dissertation work was performed under the supervision of Dr. Avery August. My primary project involved the characterization of an immuno-suppressive compound known as BTP2. As a graduate student I participated in studies examining the cell signaling events that are activated following T cell receptor stimulation of CD4+ T helper cells. In this role I became proficient at many cell signaling assays such as western blot, in vitro kinase assay, and luciferase transcriptional assays. My primary thesis project characterized the target of a small-molecule immunosuppressive drug known as BTP2. In collaboration with a group in the department of Chemistry at Penn State, I utilized a derivative of BTP2 to affinity purify potential protein binding targets of BTP2. Show less