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  • TMF Consultant

    Jessica Green

    11 years of experience 0 projects USA Research & Development
    TMF system (VV and TI) training development and process improvements AdministrationClinical OperationsRegulatorySafety & Pharmacovigilance Change controlComplianceConfigurationContent ManagementData migrationDocument QCEDMSImplementationMS OfficeMS WordPatient narrativesPharmacovigilanceProcess developmentProgram ManagementProject managementRecords ManagementSafety Case ProcessingSafety Patient NarrativesSOP development and writingTemplatesTMF Reference ModelTrackwiseTraining developmentTraining execution/managementTraining plansTransperfect Trial InteractiveTrial Master File ProcessingTrial Master File remediationVeeva Quality VaultVeeva TMF VaultVeeva VaultVendor ManagementVendor oversight and management
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    Hello,

    I am Jessica Green. Owner of Crystalline Pharmacare, LLC. I am just starting my journey of independent consulting. I have 5 years experience in Safety and 10 years experience in TMF. In Safety I was a case processor and then moved on to write narratives. During my time in Safety I found my love of improving processes. In TMF, I started as a TMF Lead, managing projects and TMF Health. I spent my last 5 years creating and implementing…

  • Assistant Professor

    Charles Williams

    20 years of experience 0 projects USA Research & Development
    Pre-INDZebrafish Pharmbio Start Up Academic experienceAssay developmentAssay validationBiochemistryBiopharm Start UpCardiovascularCell BiologyCollaboration technologiesData scienceDiscoveryDrugDrugDevEHR/EMRFeasibilityGenetic diseaseGrant Writingliterature searchesManuscriptsMicrosoft WordMolecular BiologyMS OfficeMS WordOrganoidsOrganoids/TumoridsPre-INDPublicationsRare diseaseResearchTraining developmentTraining execution/managementTraining plans
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    Assistant professor with multiple patients well versed in tech transfer and business management and pre-IND drug discovery/development.  Phenotype Evangelist,

  • LifeSciHub, LLC

    0 years of experience 0 projects USA Research & Development
    Administration Administrative
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    help for bookkeeping and quickbooks

  • Jeanette Towles

    0 years of experience 0 projects Research & Development
  • Communications Project Manager

    Carrie Leonard

    10 years of experience 0 projects USA Market Research, Research & Development
    Project management Project management
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    General Manager and Visionary Pace-Setter with progressive experience delivering incredible growth results for companies ranging from entrepreneurial start-ups to global Fortune 500 enterprises. Careerlong record of success launching new products, crafting compelling brand stories, building best-inclass business development functions, innovating new marketing and sales vehicles, and facilitating multimillion-dollar M&A transitions and exits. Incredibly diverse career includes both senior marketing and sales experience at life sciences, technology, financial services, luxury, and major media companies.

  • Researcher, Writer, Expert

    Bharathi Hattiangady, Ph.D

    19 years of experience 0 projects USA Research & Development
    CNSPublicationsRegulatory & Medical WritingToxicology
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    §  A team player with ability to perform a deep literature search and understand complex scientific topics, enthusiastic collaborator experienced in setting strategies, meeting deadlines and milestones to reach ambitious goals as evidenced by successful completion and delivery of NIH, DOD and VA funded projects and multiple collaborative projects.

    §  Expertise in writing manuscripts, study reports, IACUC and IRB protocols and driving the document review process from start to…

  • Science, Business and Patient Outcomes Expert

    Chirag Kariya, PhD

    15 years of experience 0 projects USA Market Research, Research & Development
    Clinical OperationsCommercialMarket StrategyMedical AffairsModerating / interviewingPharmbio Start UpProject managementRecruiting AdministrativeAlliance ManagementBiopharm Start UpBudget planning & managementBusiness IntelligenceClinicalClinical contractsClinical development planClinical OperationsClinical Program ManagementClinical Trial ManagementCorporateDue DilligenceKOL LiaisonMarket researchMedical AffairsNonclinicalOncologyPre-INDShared Investigator PlatformSmall pharma experienceToxicologyVendor oversight and managementWomen's health
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    Life sciences professional with an entrepreneurial mindset and experience in supporting scientific and business needs. Experience in managing preclinical and clinical drug development programs. Demonstrated strength in proactively identifying business opportunities and facilitating strategic partnerships and collaborations with stakeholders in the industry, academia, and government. Adept at implementing business strategies, conducting due diligence, and developing solutions to resolve challenges. Passionate about working at the intersection of science and business to improve patient outcomes.

  • Rong Wang

    0 years of experience 0 projects Research & Development
    Regulatory Regulatory Affairs and Strategy
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    A small, Arizona based sponsor currently in Phase II with a leading candidate in oncology, among others, looking to explore with FDA their Phase II as a transformational trial, protocol amendment/s, etc. as they move towards study start up.

  • Preclinical and Clinical Pharmacology Drug Development Expert

    Howard Ball, PhD

    32 years of experience 0 projects USA Research & Development
    Clinical Pharmacology DMPKNonclinicalPharmacologyRegulatory Affairs and Strategy
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    Clinical Pharmacologist working in the Pharma industry since 1989, in oncology, cardiovascular and respiratory therapeutic areas. An excellent communicator, writer and problem solver with broad experience in leading cross-functional project teams (preclinical pharmacology and pharmacokinetics, DMPK, safety, toxicology) for early compound selection and due-diligence activities, from IND through Phases I-III and BLA/NDA submission with regulatory agency experience. In-depth understanding of PKPD, pharmacometrics, population PK and translational medicine

  • Study Start Up Expert

    Swadesh Sharma

    25 years of experience 0 projects USA Market Research, Research & Development
    Clinical OperationsLife Sciences IT Clinical OperationsClinical Trial ManagementFeasibilityLife Sciences ITMonitoringRegulatoryScreeningStudy start up
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    A proven operational leader who offers a record of success in introducing strategies that drive growth, define short-and  long-term  strategic  vision,  and  create  a  positive  company image.  Builds productive internal and external relationships to advance corporate revenue  achievements,  while delivering significant time  and cost savings. Hires, trains, mentors, and leads teams across multiple disciplines.

  • Medical editing and content

    Lyra Fiske

    19 years of experience 0 projects USA Research & Development
    Scientific content editing CommercialMedical Affairs EditingMedical Affairs
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    Medical editing and content management system experience

  • Senior Medical Science Liaison

    Carl Clay, MO

    18 years of experience 0 projects USA Research & Development
    Medical Affairs Medical Affairs
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    Having helped launch Brilinta (ticagrelor tablets), Onglyza (saxagliptin), Farxiga (dapagliflozin), NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid / ezetimibe) and supported the post-launch activities of VASCEPA (icosapent ethyl) and Feraheme (ferumoxytol), I have become an accomplished Executive Medical Science Liaison and a tireless and passionate teammate, mentor, and leader in support of medical affairs activities.

    I have covered multiple territories including the Atlantic States and Midwest (when I lived in Wilmington, DE), the Southwest and Northeast, Texas, and…

  • Sr. Medical Monitor/Advisor

    Marina Lewis, MD PhD

    20 years of experience 0 projects USA Research & Development
    Oncology Medical Affairs Medical Affairs Medical AffairsMedical monitoringPharmacovigilance
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    Marina Lewis, MD, PhD. Experienced Medical Director with a demonstrated history of working in the pharmaceuticals industry and Medical Device industry. Extensive experience in research in Academic setting. Experience in medical fields including Oncology, Hematology, Pulmonology, Pediatrics and Cardiovascular surgery. Twenty-plus years in research: Pathology, Microbiology, Histology, Cell Therapy, Immunotherapy, Molecular Biology and Immunology.Graduated from the Medical Academy of Sciences, Institute of Pediatrics, Moscow, Russia.

  • Sr. Pharmacovigilance Consultant

    Sajan Varughese

    24 years of experience 0 projects USA Research & Development
    EndocrinologyGIHematologyOncologyRare DiseaseRenal Safety & Pharmacovigilance AE/SAE ReportingArgus/OracleDrug SafetyDue DilligenceEndocrinologyGVPHealth CanadaHematologyInvestigational/pre-marketInvestigators BrochureMedDRAMedical codingMedical DeviceMedical surveillancePainPatient narrativesPDMAPharmacovigilanceRisk Based MonitoringRisk ManagementRisk Management PlanningSAE reconciliationSafety AnalyticsSafety due dilligenceSafety Management PlanSignal DetectionVendor oversight and managementVendor selection
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    Twenty-four years of experience in the Pharmaceutical Industry mostly in Global Pharmacovigilance and Risk Management department. Very deep understanding of functions within Research & Development (such as Clinical Development, Regulatory Affairs, and Medical Affairs) and outside of R&D (QA, Supply Chain, and Commercial). Within Pharmacovigilance, expert in Clinical Trial and Postmarketing Safety; Aggregate reports; global Risk Management Plans; PV Operations; Outsourcing (medical information and pharmacovigilance); and Vendor management. Longstanding expertise in risk management issues associated with drugs…

  • Physical Therapist Pain Neuroscience Specialist

    Paul Leverson

    15 years of experience 0 projects USA Market Research, Research & Development
    Neuroscience of Pain and Performance Clinical OperationsMarket StrategyMedical Affairs ClinicalClinical OperationsClinical Project ManagementPainPain managementPatient engagementPatient Experience
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    My name is Paul Leverson. 

    I am a practicing physical therapist with 27+ years of experience serving general outpatient orthopedic clients. In addition, I am certified in pain science through EIM since 2015.

    My training in pain science allows me a particular perspective as to the biology of pain, neuroplasticity and neurosensitivity, specifically, actions and reactions.  This is valuable information to understand not only in the effective treatment of pain, but also in understanding how environmental stimuli   – from…

  • Clinical Development Expert, MD PhD

    Andrew Shenker

    30 years of experience 0 projects USA Research & Development
    Clinical development plangene therapyRare disease
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    Physician-scientist with expertise in rare diseases and gene therapy and over 25years of leadership and management experience in academic, biotech and pharmaceutical industry settings.

    •Led teams responsible for key aspects of the clinical development of 4marketed drugs:•Eliquis® (apixaban) Factor Xa inhibitor for thromboembolic disease

    •Galafold™ (migalastat) chaperone for Fabry disease

    •Tegsedi™(inotersen)antisense oligonucleotide for the polyneuropathic form of transthyretin amyloidosis

    •Libmeldy™autologous hematopoietic stem cell (HSC)lentiviral gene therapy for metachromatic leukodystrophy(MLD)

    •Expertise in clinical pharmacology, biomarker strategy, and clinical development of novel…

  • NA

    Adeline Crinier

    5 years of experience 0 projects France Market Research, Research & Development
    Life Sciences Business Intelligence
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    NA

  • Senior Director, Regulatory Operations

    Kiyoung Hong

    22 years of experience 0 projects USA Research & Development
    Regulatory eCTDEDMSExtedo eCTDManagerLiquent-Parexel InsightLornez DocubridgeVeeva Vault
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    Technical and operation oriented Regulatory professional with 21+ years of Regulatory Operations experience

    Extensive experience in Regulatory Submission Management and strong background in eCTD and NeeS based submission formats

    Well versed in Regulatory Systems/Applications selection and implementation process (Electronic Document Management Systems, Submission Document Authoring, eCTD Publishing, Submission Viewing and Submission Validation)

    Experienced in building and re-organizing Regulatory Operation organization based on business needs

    Experienced in aligning systems and processes between Regulatory and cross-function touch points (Adpromo, Quality, eTMF, PV…

  • Administration Expert

    Cel Rona

    15 years of experience 1 project Philippines Research & Development
    Administrative
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    Hi There, I am an Admin Expert.

  • Elizabeth Venafro

    0 years of experience 0 projects Research & Development
    Safety & Pharmacovigilance Business Intelligence
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    Looking for a pharma R&D  SME to help us develop use cases, gain traction with early adopters and refine our offerings to be in further alignment with the life sciences R&D space.

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