Rosemary Richter Mph, Jd

Rosemary Richter Mph, Jd Email and Phone Number

Regulatory Medical and Pharmacovigilance Writer and Manager @ Meddybemps, ME, US
Meddybemps, ME, US
Rosemary Richter Mph, Jd's Location
New York City Metropolitan Area, United States, United States
Rosemary Richter Mph, Jd's Contact Details

Rosemary Richter Mph, Jd work email

Rosemary Richter Mph, Jd personal email

n/a
About Rosemary Richter Mph, Jd

+ 25 years of experience with managing, planning, writing documentation used in global regulatory and pharmacovigilance submissions over the entire clinical regulatory life-cycle of drugs, biologics and medical devices for start-up through Fortune 500 companies and CROs; including but not limited to: • oncology [mAbs, VEGF-Trap, small molecules] • cardiovascular, • anti-infectives, • immunosuppressants, • vaccines, • neurology/psychiatric, • Class I-III medical devices, • RX-OTC switchesMPH Epidemiology & Biostatistics (focus on oncology)JD +6 years of litigation experience involving Federal Law and Agencies for toxic torts, wrongful death, and medical products liability claims Specialties:Team Management, Writing, QC and Timeline creation forLiterature Review, IND, IDE, IMPD, CTA, Protocol, CSR, IB, Annual Reports, ISS, ISE, eCTD Modules 2.5, 2.7.1, 2.7.2, 2.7.3, 2.7.4 & 5Briefing Packages for regulatory authoritiesPSUR, Bridging Reports and related Aggregated Safety pharmacovigilance reportsLabeling, CCDS/CCSI, USPSOPs, eCTD templates, electronic document management systemsInteractions with regulatory agencies, co-developers, external & internal project management

Rosemary Richter Mph, Jd's Current Company Details
PRN Clinical Services, Inc.

Prn Clinical Services, Inc.

Regulatory Medical and Pharmacovigilance Writer and Manager
Meddybemps, ME, US
Rosemary Richter Mph, Jd Work Experience Details
  • Prn Clinical Services, Inc.
    Regulatory Medical And Pharmacovigilance Writer And Manager
    Prn Clinical Services, Inc.
    Meddybemps, Me, Us
  • Prn Clinical Services, Inc.
    Regulatory Medical & Pharmacovigilance Writer & Manager
    Prn Clinical Services, Inc. Jan 1995 - Present
    Plan, write, edit and manage the preparation and production of clinical documentation (Protocol, IB, CSR, Narrative, IND, IDE, IMPD, CTA, Labeling, Annual Updates, Efficacy & Safety Integrated Summaries,eCTD Modules 2.5, 2.7, & 5) for: NDA, PMA, BLA, MAA, PSUR
  • Interpore International (A Subsidiary Of Biomet)
    Manager Of Clinical Research & Medical Writing
    Interpore International (A Subsidiary Of Biomet) 1982 - 1986
    Class I & III porous hydroxyapatite bone graft substitues for orthopaedic, spinal, cranio-facial, oral surgical indications
  • J&J Products Inc.
    Clinical Research Associate & Medical Writer
    J&J Products Inc. 1979 - 1982
    Class I-III medical devices: porous hydroxyapatite bone graft substitutes, artificial ligament, synthetic external fracture immobilization, adsorbable collagen hemostat, wound and burn dressings, post-surgical wound drainage system, tampons, and OTC consumer products.
  • Bristol-Myers Squibb
    Clinical Information Scientist
    Bristol-Myers Squibb 1977 - 1979
    Lawrence Township, Nj, Us
    Reviewed and cleaned clinical data, wrote queries, participated in the preparation of Phase 1-3 case report forms, protocols and CSRs for the captroril and nadolol NDAs and anti-fungal studies
    View

Rosemary Richter Mph, Jd Skills

Regulatory Submissions Pharmacovigilance Medical Writing Oncology Clinical Research Biologics Pharmaceutical Industry Vaccines Ind Clinical Trials Clinical Development Biotechnology Life Sciences Regulatory Medical Writing Management Of Medical Writers And Submission And Dossier Clinical Teams Labeling Drugs Sop Protocol Medical Devices Cro Regulatory Affairs Gcp Drug Development

Rosemary Richter Mph, Jd Education Details

  • Columbia University Mailman School Of Public Health
    Columbia University Mailman School Of Public Health
    Epidemiology
  • Seton Hall University School Of Law
    Seton Hall University School Of Law
    Doctor Of Laws
  • Fordham University
    Fordham University
    Biological Sciences
  • Columbia University Mailman School Of Public Health
    Columbia University Mailman School Of Public Health
    Epidemiology

Frequently Asked Questions about Rosemary Richter Mph, Jd

What company does Rosemary Richter Mph, Jd work for?

Rosemary Richter Mph, Jd works for Prn Clinical Services, Inc.

What is Rosemary Richter Mph, Jd's role at the current company?

Rosemary Richter Mph, Jd's current role is Regulatory Medical and Pharmacovigilance Writer and Manager.

What is Rosemary Richter Mph, Jd's email address?

Rosemary Richter Mph, Jd's email address is rr****@****att.net

What schools did Rosemary Richter Mph, Jd attend?

Rosemary Richter Mph, Jd attended Columbia University Mailman School Of Public Health, Seton Hall University School Of Law, Fordham University, Columbia University Mailman School Of Public Health.

What skills is Rosemary Richter Mph, Jd known for?

Rosemary Richter Mph, Jd has skills like Regulatory Submissions, Pharmacovigilance, Medical Writing, Oncology, Clinical Research, Biologics, Pharmaceutical Industry, Vaccines, Ind, Clinical Trials, Clinical Development, Biotechnology.

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