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Work Background
BioclinicaDirector, Medical Communications
Mar. 2020 - Jul. 2021Princeton, New Jersey, United States
BioClinica, Inc.Senior Manager, Medical Communications
Mar. 2013 - Mar. 2020Princeton, NJSee CoreLab Partners, Senior Manager, Medical Communications
CoreLab Partners, Inc. (Formerly RadPharm, Inc.)Senior Manager, Medical Communications
Oct. 2010 - Mar. 2013Princeton, NJAs Senior Manager, continued to manage the Medical Communications department while maintaining full-time writer duties. Reviewed Charters and Imaging Manuals prepared by other Medical Writers. Chaired the Charter Standards Committee, an interdepartmental group committed to preserving language and processes consistent with regulatory and company guidelines. Participated in Pharmaceutical Imaging Group discussions with various Independent Review Facilities, Sponsors and the FDA, and drafted a journal article on the creation of Imaging Charters. Reviewed and edited journal articles and poster presentations. Participated in FDA audits as a scribe. Continued to maintain other responsibilities as detailed below (see Manager, Medical Communications).
RadPharmManager, Medical Communications
Jul. 2008 - Oct. 2010Princeton, NJAssumed the responsibility of managing a team of medical writers (MWs). During my tenure as Manager, the Medical Communications department assumed responsibility over multiple document types to ensure consistency with the Independent Review Charters as well as to guarantee professional and corporate document standards. Continued to author Charters, Imaging Manuals, Clinical Data Transfer Plans (CDTPs), Image Quality Assurance (IQA) Summaries, Charter-related Deviation Reports and other imaging- and Protocol-related documents. Responsible for the creation and maintenance of Sponsor- and criteria-specific templates. Supervised, trained and mentored other Medical Communications staff. Continued maintenance over Medical Communications database and web pages (including the creation of additional web pages for Imaging Manuals, CDTPs, and Charter training slides). Participated in the Clinical Operations Project Manager training program by developing four Medical Communications training modules. Other responsibilities as detailed below (see Senior Medical Writer).
RadPharmSenior Medical Writer
Jan. 2008 - Jul. 2008Princeton, NJAssumed the responsibility of managing three MWs. Continued to author Charters and Imaging Manuals. Reviewed Charters and manuals created by other MWs. Prepared Sponsor- and criteria-specific (e.g., RECIST, Cheson, Macdonald, EORTC, WHO, etc.) Charter templates for use by Medical Communications staff. Involved in the creation of the Imaging Manual template. Developed a 6-week intensive Medical Writing training plan for new MWs, specific to RadPharm. Responsible for providing Charter status/project updates to Clinical Operations upper management, as well as monthly Finance reports for Medical Communications billable documents. Established MW metrics based on Charter turnaround times, MW writing statistics and study-to-writer ratios to support additional staffing requirements. Continued maintenance over Medical Communications database and web pages. Liaised with Sponsors and internal RadPharm physicians and Project Team members during study start-up activities (e.g., Charter and manual creation, kick-off meetings). Trained and mentored new/other MWs. Continued other responsibilities as detailed below (see Medical Writer).
RadPharmMedical Writer
Aug. 2006 - Dec. 2007Princeton, NJResponsible for authoring Independent Review Charters focused on oncology studies. Established the MW database using Microsoft Access, which tracks all awarded studies, as well as study-related, document and MW information. Developed web pages for RadPharm personnel, which directed them to all internally published Charters, Protocols and IQA Summaries. Participated in the DIA-sponsored FDA/Medical Imaging group and actively took part in the creation of a Medical Imaging template designed for Charter harmonization across all imaging core labs. Created RadPharmโs Medical Imaging RECIST Charter template based on the FDA-recommended imaging template. Improved Charter development processes by decreasing Charter turnaround times, standardizing language and improving Charter quality. Prepared weekly spreadsheets for Clinical Operations upper management detailing Charter status and project updates. Assisted in formatting journal article submissions to conform to JAMA, ICMJE and AMA guidelines. Stayed current with FDA requirements related to Medical Imaging Charters.
The College of New JerseyGraduate Assistant/Graduate Student
Aug. 2004 - Mar. 2006Ewing, NJEnglish Department graduate assistant. Performed literature searches for English comprehensive exams; proofread, edited and citation-checked manuscripts in preparation for publication; proctored examinations; designed, created, and prepared pamphlets, brochures and posters for various English Department sponsored symposiums; modified EndNote libraries to be project specific for various faculty members; and created user-guides and technical manuals on the use of EndNote and WordPerfect.
RJ StaffingScientist/Document Control Consultant for Barr Laboratories
Apr. 2004 - Sep. 2004Plainsboro, NJConsulted for Barr Research. Wrote development reports, research protocols and IQ/OQ protocols for transvaginal rings and drug-loaded controlled release silicone devices. Reviewed SOPs, test methods, specifications, master formulas and batch records. Provided guidance, technical assistance and historical background for the continuation of the development, clinical manufacturing and optimization processes for transvaginal ring devices and other drug-loaded controlled release silicone devices. Trained a Barr QA Associate on the R&D document control system and database; prepared a comprehensive project progress report of all historical FEI/Enhance and Barr transvaginal/silicone-based projects.
Barr Research (a Division of Barr Laboratories)Research Scientist/Document Controller
Jun. 2002 - Apr. 2004Plainsboro, NJAs a scientist, main responsibilities involved formulating, developing and preparing pre-clinical and Phase I or Phase I/II clinical supplies for transvaginal rings and devices. Performed informal audits of contract labs and vendors prior to Phase I/Phase II contract manufacturing. Prepared the CMC section of several pre-INDs and INDs. Knowledgeable in cGMPs, cGLPs, CFR 21. Performed regular SOP and OJT training for Research/Process Development scientists and technicians. Qualified trainer for laboratory notebook formatting and review. Other responsibilities as detailed below (see Scientist roles under Enhance Pharmaceuticals). As a document controller, responsibilities included creating, implementing and maintaining an R&D-specific SOP and documentation control system, designed to take into account a more accommodating approach designed for research while still maintaining cGMPs. R&D SOPs were comprehensive, covering global and research-specific procedures, document review and approval, health and safety, equipment procedures, specification and test method preparation, IQ/OQs, controlled environment activities, and manufacturing experimental, pre-clinical and clinical batches. The document control system was available in both paper and electronic formats. Primary coordinator between R&D and QA/RA regarding manufacturing and document control activities. Prepared, reviewed and approved SOPs, specifications, test methods, master formulas and batch records, feasibility proposals and studies, IQ/OQ protocols and reports, poster presentations, journal articles and patent draft applications. Handled inventory, control and dispensing of restricted materials.
Enhance Pharmaceuticals, Inc.Senior Research Scientist, Formulations and Clinical Research
Dec. 2001 - Jun. 2002Plainsboro, NJMain responsibilities involved formulating, developing and preparing pre-clinical and Phase I or Phase I/II clinical supplies for transvaginal rings and drug-loaded controlled release silicone devices. Oversaw animal studies (pre-clinical) using prepared ring products and ensured GLPs were followed during animal testing. Prepared research and development protocols focused on the pharmacokinetics, pharmacodynamics, chemistry, manufacturing and stability of drugs and drug products under study. Performed informal audits of contract labs and vendors prior to Phase I and Phase II manufacturing. Prepared the CMC section of several pre-INDs and INDs. Knowledgeable in cGMPs, CFR 21. Performed regular SOP and OJT training for Research/Process Development scientists and technicians. Qualified trainer for notebook formatting and review.
Enhance PharmaceuticalsSenior Research Scientist, Formulations and Clinical Research
Jan. 2001 - Nov. 2001Plainsboro, NJResponsibilities included feasibility and pre-formulation studies, formulation development, pre-clinical and clinical manufacturing of transvaginal, intrauterine and implantable drug delivery devices. In charge of the preparation of patent draft applications and presenting journal articles or poster presentations at different industry conferences. Prepared the CMC section of pre-IND packages for several projects. Prepared numerous SOPs, master formulas, test methods and specifications as well as IQ/OQ protocols and reports. Developed databases for lab inventory and R&D purchasing. Purchased lab equipment (i.e., UVs, HPLCs, dissolution baths) and supplies. Directly supervised technicians, lab assistants and summer interns. Comprehensive experience as lead scientist on various controlled release (CR) and immediate release (IR) vaginal ring and drug delivery projects.
Enhance PharmaceuticalsResearch Scientist, Process Development and Engineering
Dec. 1999 - Jan. 2001Plainsboro, NJResponsibilities included qualification and process optimization of manufacturing processes for scale-up of transvaginal, intrauterine and implantable drug delivery devices. Wrote, reviewed and approved IQ/OQ and Process Qualification (PQ) protocols and reports. Prepared numerous manufacturing, equipment and process SOPs, test methods and device specifications.
FEI TechnologiesInterim Group Leader, Research and Process Engineering
Sep. 1999 - Dec. 1999Plainsboro, NJDuring the merging of the R&D and Process Development departments, acted as Interim Group Leader. Managed lab assistants, technicians and engineers. Provided operational support to the Process Development team while still maintaining scientist responsibilities for the continued development of transvaginal rings and other drug devices.
FEI TechnologiesResearch Scientist, Formulations R&D
Mar. 1999 - Sep. 1999Plainsboro, NJPrimary responsibilities include feasibility and pre-formulation studies, formulation development, pre-clinical and clinical manufacturing of transvaginal, intrauterine and implantable drug delivery devices. In charge of the preparation of patent draft applications and presenting journal articles or poster presentations to different industry conferences. Prepared the CMC section of an IND package for an FDA fast-tracked project. Coordinated activities between Formulations and Process Development as needed. Also performed process optimization and scale-up, technology transfer and manufacturing clinical supplies for Phase I and II studies. Responsible for purchasing lab equipment (i.e. UVs, HPLCs, dissolution baths) and supplies.
Secondary responsibilities included the preparation and review of SOPs, specifications, master formulas and batch records, feasibility proposals and studies, IQ/OQ protocols and reports. Knowledgeable in cGMPs and DOE. Skilled in manufacturing in cleanroom environments. Performed regular SOP and OJT training for Research/Process Development scientists and technicians. Qualified trainer for notebook formatting and review. Directly supervised technicians, lab assistants and summer interns.
FEI TechnologiesAssistant Research Scientist, Formulations R&D
Dec. 1997 - Mar. 1999Plainsboro, NJPrimary responsibilities include feasibility and pre-formulation studies, formulation development, pre-clinical and clinical manufacturing of transvaginal, intrauterine and implantable drug delivery devices. Prepared patent draft applications and poster presentations. Coordinated activities between Formulations and Process Development as needed. Responsible for setting up the new Formulations R&D lab.
Whitehall Robins Healthcare (Wyeth Consumer Products)Assistant Research Scientist
Aug. 1993 - Nov. 1997Hammonton, NJMain responsibilities included the research, formulation and product support of new and/or existing liquid and semi-solid drug products, for both monographal and new drug applications. Other duties included technical writing, method development and supervision of technicians/summer interns. Extensive computer skills, a familiarity with cGMP guidelines and a knowledge of Design of Experiments were required of the position. Comprehensive formulation experience on the following: Female Contraceptive Inserts/Sponge (Semicid, Today), Hemorrhoid ointments/creams (Preparation H), Oral Mucoadhesive Gels (Anbesol Long Lasting), Oral Anesthetics (Anbesol), Antacid Suspensions (Riopan), H2-antagonist syrup (Liquid Axid), Nasal Sprays/Solutions (Dristan), and Dandruff Shampoos (Denorex).
The College of New JerseyChemistry Research Assistant
Jan. 1989 - Dec. 1993Responsible for the testing, preparation and setting up of labs for both general and advanced chemistry courses. Developed new and practical experiments appropriate for advanced chemistry labs, created lab write-ups and assisted professors in lab. Oversaw the proper use and care of various analytical instruments and organic labware.
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