Peter J. Conroy, PhD, JD
Director, Regulatory Medical Writing @ Rocket Pharmaceuticals
About
Peter J. Conroy is a regulatory medical writer with more than 15 years experience. He also has 15+ years of clinical development experience, 5 years of preclinical toxicology, and is a board-certified patent attorney. Peter has proven team leadership ability and significant clinical management experience. Peter's medical writing experience includes multiple therapeutic areas: biosimilars, immunology, auto-immune diseases, oncology, anti-infectives, anti-inflammatory, anti-allergy, ophthalmic, and otic drugs. Career accomplishments include FDA approval of 7 NDAs, 2 BLAs, 3 MAAs and 3 PMAs. He has written more than 70 scientific publications (papers and abstracts) as either principal author or co-author. As medical writer, he has written or prepared 250+ regulatory documents including clinical protocols, CSRs, Investigator Brochures, Informed Consents, DSURs, PSURs, IMPDs, INDs, CTXs, ISS/ISE sections, Clinical Overviews, NDA and BLA modules 2 and 5, and responses to FDA and EU Regulatory Questions.
United States
Denver
Pharmaceuticals
Site Management, Cross-functional Coordination, Ophthalmic drug development, CTAs, Ophthalmic drugs, Topical adminstration, Allergy and Immunology, Infection, Anti-Infective agents, Phase 1 to 3 clinical trials, Director level, Supervision of CRAs, CRA Management, NDAs, MSAs, Work Orders, Contracts, Outsourcing Management, Project Management, Clinical Development Consulting
Experience
Director, Regulatory Medical Writing
Rocket Pharmaceuticals
Cranbury, NJ, United States
Director of Medical Writing
Rocket Pharmaceuticals
Denver, Colorado, United States
Led medical writing team for FDA and EMA regulatory submissions to support innovative gene therapy cures of rare pediatric diseases.
Director of Medical Writing
Rocket Pharmaceuticals
Denver, Colorado, United States
Led medical writing team for FDA and EMA regulatory submissions to support innovative gene therapy cures of rare pediatric diseases.
Director, Regulatory Medical Writing
Invivyd
Director of Medical Writing
Invivyd
Colorado Springs, Colorado, United States
Directs and supervises medical writing team for eCTD regulatory submissions to support monoclonal antibodies for prevention and treatment of COVID-19.
Director of Medical Writing
Invivyd
Colorado Springs, CO.
Directed and supervised medical writing team for eCTD regulatory submissions to support monoclonal antibodies for prevention and treatment of COVID-19.
Director, Head of Medical and Scientific Writing
Mallinckrodt Pharmaceuticals
Director, Head of Medical Writing
Mallinckrodt Pharmaceuticals
Colorado Springs, Colorado, United States
Directed medical writing team for regulatory submissions of products for treatment of rare diseases. Responsibilities include briefing packages, eCTD sections, NDA/BLAs, Protocols, CSRs, IBs, and responses to questions from regulatory agencies (FDA/EMEA).
Director, Regulatory Medical Writing
Kite Pharma
Santa Monica, California, United States
Director of Medical Writing
Kite Pharmaceutical
Colorado Springs, Colorado, United States
Led and supervised medical writing team for regulatory submissions of CAR T cell products. Responsibilities included briefing packages, eCTD Module 2 and 5 sections, IND/BLA sections, CSRs, IBs, and coordination of responses to questions from regulatory agencies.
Director of Medical Writing
Cardinal Health
Colorado Springs, Colorado, United States
Led and supervised medical writing team for late phase regulatory submissions of oncology, anti-inflammation biosimilars, immunology and biopharmaceutics
Director, Regulatory Medical Writing
Cardinal Health
Colorado Springs, CO (Home-Based)
Principal Medical Writer
Worldwide Clinical Trials
Colorado Springs, CO (Home-Based)
Principal Medical Writer
Worldwide Clinical Trials
Colorado Springs, Colorado, United States
Built and led team of 6 Medical Writers. Team Leader for late phase regulatory documents, including IND/NDA/BLA sections, responses to regulatory agencies.
Senior Medical Writer
INC Research
Fort Worth, Texas (Home-Based)
Sr. Medical Writer
INC Research
Fort Worth. TX
Led Medical Writer for key CSRs, IND and NDA Sections, CTX and CTDs, Protocols, CSRs, IBs, DRMPs, DSURs and PSURs for Phase II-IV studies.
Owner and Principal
Clinical Outsource Consulting, LLC
Fort Worth, Texas (Home-Based)
Principal Owner
Clinical Outsource Consulting, LLC
Fort Worth. TX
Provided Medical Writing and Clinical Outsourcing services to pharmaceutical companies.
Clinical Outsourcing Head
Alcon
Fort Worth, Texas
Associate Director, Contracts & Finance, Clinical Operations
Alcon
Fort Worth, Texas
Associate Director, Clinical Unit Head
Alcon
Fort Worth, Texas
Assistant Director, Clinical Development
Alcon
Fort Worth, Texas
Manager, Clinical Development
Alcon
Fort Worth, Texas
Manager, International Clinical Development
Alcon
Fort Worth, Texas
Education
Brunel University of London
Biochemistry
Texas A&M University School of Law
Contracts, Intellectual Property, Patent Law
Brunel University of London
Applied Biology
Texas A&M University School of Law
Contracts, Intellectual Property, Patent Law
Peter J. Conroy, PhD, JD's Contact Information
Phone
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