Chris Jennings

Chris Jennings Email and Phone Number

Contract Regulatory and Medical Writer @ Chris Jennings
Boston, MA, US
Chris Jennings's Location
Greater Boston, United States
About Chris Jennings

I excel at helping small companies overcome their chaos to generate precise text for regulatory documents. Available for 100% remote contract regulatory medical writing. Highly experienced in working independently, engaging team members, and driving the project to completion. I offer 20+ years of providing clear regulatory, clinical and scientific text to biotechnological, pharmaceutical, and medical product companies.NDA/IND/BLA documents include protocols, clinical study reports (CSR), meeting/briefing packages, orphan drug designation, periodic safety reports, Module 2, informed consent forms (ICFs), narratives, investigators brochures (IBs), and publications, monographs, posters, abstracts, as sole author. Collaboratively worked on safety reports (DSUR, PSUR) and integrated safety study (ISS) and a handful of other documents.Indications included oncology, novel genetic (DNA-reading) diagnostics, gene therapy, in vitro diagnostics (IVD), immunology, HIV/AIDS, ophthalmology, antibiotics, monoclonal antibodies, etc.

Chris Jennings's Current Company Details
Chris Jennings

Chris Jennings

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Contract Regulatory and Medical Writer
Boston, MA, US
Website:
chrisnmaddy.com
Chris Jennings Work Experience Details
  • Chris Jennings
    Contract Regulatory And Medical Writer
    Chris Jennings
    Boston, Ma, Us
    View
  • Chris Jennings
    Contract Regulatory & Medical Writer
    Chris Jennings Jan 2000 - Present
    *** ONLY SELECT CLIENTELE LISTED BELOW ***Providing clear regulatory, clinical, and scientific text to pharmaceutical, biotechnological, diagnostic, and medical product companies.
  • Telix Pharmaceuticals Limited
    Contract Regulatory Writer
    Telix Pharmaceuticals Limited Nov 2023 - Present
    North Melbourne, Australia.
    To date, have composed regulatory documents for 5 investigational and 1 approved radiopharmaceuticals, including 7 Module 2 sections, 8 protocols, 3 CSR revisions (including SOCs and a corrigendum), and a complete Investigator’s Brochure under extreme deadline pressures (see Recommendations).
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  • Biomx Inc
    Contract Regulatory Writer
    Biomx Inc Sep 2022 - Present
    Completed 6 clinical study reports (CSRs) for 6 cosmetic indications to clear out the backlog. Assisted with 3 protocol amendments, and a blinding/unblinding plan. Performed "sanity check" on variety of clinical documents generated in-house.
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  • Micurx Pharmaceuticals, Inc.
    Contract Medical Writer
    Micurx Pharmaceuticals, Inc. Oct 2023 - Nov 2023
    Foster City, Ca; Shanghai, China
    Prior to submission to the International Journal of Antimicrobial Agents, the final version of the manuscript composed by a team of Chinese scientists residing in China underwent editorial revision by Chris Jennings to improve the presentation of our data in English; funding provided by MicuRx Pharmaceuticals, Inc.
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  • Remegen荣昌生物
    Contract Regulatory Writer
    Remegen荣昌生物 Apr 2022 - Jan 2023
    Aided client with 3 meeting packages, revisions of Modules 2.4 and 2.6 for two investigational agents, an Orphan Drug Designation (ODD) Application, a protocol amendment and revision of ICFs
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  • Synchrogenix, A Certara Company
    Senior Regulatory Writer
    Synchrogenix, A Certara Company Nov 2020 - Dec 2021
    Worked solely or collaboratively on dozens of familiar regulatory documents plus DSURs, PSURs, ISSs, ISEs, and a handful of other documents
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  • Advyzom
    Contract Regulatory Writer
    Advyzom Sep 2017 - Apr 2020
    Primarily performed Module 2.7.3 and Module 2.7.4 rescues and composed 500 narratives while editing and QC hundreds of others as part of an 8-month team project involving 4 ongoing clinical trials comprising thousands of subjects
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  • Ora, Inc.
    Contract Regulatory Writer
    Ora, Inc. Mar 2014 - Jul 2018
    As sole author, completed a series of 16 clinical study reports (CSRs) and 3 manuscripts for peer-to-peer journal submission
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  • Illumina
    Contract Regulatory Writer
    Illumina Feb 2012 - Jun 2012
    As sole author, completed two CSRs for 510(k) submission of first-of-kind diagnostic assay to detect cytogenetic abnormalities
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  • Regenerx Biopharmaceuticals, Inc.
    Contract Regulatory Writer
    Regenerx Biopharmaceuticals, Inc. 2007 - Dec 2009
    A series of 10 or so protocol amendments, clinical study reports (CSRs) plus I.B. amendments, abstracts, and posters.
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  • Bayer
    Contract Medical Writer
    Bayer Mar 2006 - Feb 2009
    Served a 3-year contract as a Preferred Vendor for Bayer HealthCare LLC, Diagnostics Division, Tarrytown NY; composing trade journal articles, manuscripts for submission peer-to-peer journals, and spec sheets.
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Chris Jennings Education Details

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Chris Jennings's current role is Contract Regulatory and Medical Writer.

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Chris Jennings attended Harvard College.

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