Meagan Eldridge

Meagan Eldridge Email and Phone Number

I write regulatory documents and lead clinical writing programs to advance development of life-saving and life-improving therapies. @ Eldridge Writing & Consulting LLC
Meagan Eldridge's Location
Rocky Mount-Wilson Area, United States
About Meagan Eldridge

I'm an agile, collaborative medical writing partner, specializing in development of strategic, efficient, and high-quality clinical and regulatory documents for small molecules and biologic programs.I’ve worked with biopharma companies, large and small, to:--Reliably and nimbly meet aggressive submission timelines for clinical modules of new drug applications (NDAs)/biologics license applications (BLAs)/marketing authorisation applications (MAAs), briefing packages, and responses to requests for information (RFIs).--Streamline writing & reviewing processes for documents like clinical study reports (CSRs), clinical study protocols (CSPs)/amendments, investigator's brochures/updates, using various platforms (eg, SharePoint, Veeva, PleaseReview).--Ensure deliverables and submission packages are accurate, well organized, and on message.----------------------------------Check out www.meaganeldridge.com for more information.

Meagan Eldridge's Current Company Details
Eldridge Writing & Consulting LLC

Eldridge Writing & Consulting Llc

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I write regulatory documents and lead clinical writing programs to advance development of life-saving and life-improving therapies.
Meagan Eldridge Work Experience Details
  • Eldridge Writing & Consulting Llc
    President
    Eldridge Writing & Consulting Llc Jun 2023 - Present
    North Carolina, United States
    Author high-quality regulatory documents (eg, CSRs, CSPs, IBs, briefing documents, clinical modules for NDAs/BLAs/MAAs) and lead clinical writing programs for small molecules and biologics.
  • Pliant Therapeutics
    Senior Director, Regulatory Medical Writing
    Pliant Therapeutics Feb 2023 - Jun 2023
    Led writing and cross-funtional review processes for briefing documents, INDs, fast track applications, orphan drug designation applications, breakthrough therapy designation applications, IBs, DSURs, and clinical study protocols; trained and mentored junior medical writers; identified and managed external resources; developed and maintained internal style guide; implemented use of ICH-standardized StartingPoint templates; incorporated QC checks; managed use of review platforms (ie, PleaseReview, SharePoint); strategically reviewed CSRs, SAPs, and TFLs
  • Pliant Therapeutics
    Director, Regulatory Medical Writing
    Pliant Therapeutics Sep 2021 - Feb 2023
    North Carolina, United States
  • Webbwrites, Llc
    Senior Medical Writer
    Webbwrites, Llc Dec 2018 - Sep 2021
    Durham, North Carolina
    Developed strategy for content and organization of clinical regulatory documents for NDAs, BLAs, and MAAs (eg, protocols, CSRs, narratives, ISS, SCE/Module 2.7.3, and SCS/Module 2.7.4, clinical overviews [Module 2.5], investigator's brochures, briefing documents) across various therapeutic areas.Collaborated with cross-functional Sponsor teams (eg, global clinical leads, statistics, regulatory, pharmacovigilance, clinical operations); managed project workflows and resources; led team roundtable meetings; performed QC review of documents, including 100% source verification; reviewed statistical tables, figures, and listings; developed and reviewed timelines; assisted with proposals, bids, and new client onboarding; ensured compliance with eCTD, ICH, and GCP guidelines.
  • Webbwrites, Llc
    Medical Writer
    Webbwrites, Llc Apr 2016 - Dec 2018
    Raleigh-Durham, North Carolina Area
  • Webbwrites, Llc
    Assistant Medical Writer
    Webbwrites, Llc Apr 2015 - Apr 2016
    Raleigh-Durham, North Carolina Area
  • Webbwrites, Llc
    Medical Writing Intern
    Webbwrites, Llc Dec 2014 - Mar 2015
    Raleigh-Durham, North Carolina Area
  • University Of North Carolina At Chapel Hill
    Graduate Research Assistant
    University Of North Carolina At Chapel Hill Aug 2012 - Dec 2014
    Chapel Hill, North Carolina
    Prepared protocols, comprehensive literature reviews, grant proposals, and abstracts; Reviewed and edited scientific documents written by peers;Managed and performed studies using pre-clinical mouse models of pancreatic cancer to assess efficacy of chemotherapeutic drugs;Analyzed and interpreted pre-clinical data;Worked with a team of individuals from various backgrounds, including statistics, computer science, epidemiology, biomedical engineering, and genetics;Performed specific laboratory techniques, including polymerase chain reaction (PCR), western blots, Southern blots, flow cytometry, and tissue culture.

Meagan Eldridge Education Details

Frequently Asked Questions about Meagan Eldridge

What company does Meagan Eldridge work for?

Meagan Eldridge works for Eldridge Writing & Consulting Llc

What is Meagan Eldridge's role at the current company?

Meagan Eldridge's current role is I write regulatory documents and lead clinical writing programs to advance development of life-saving and life-improving therapies..

What schools did Meagan Eldridge attend?

Meagan Eldridge attended University Of North Carolina At Chapel Hill, University Of North Carolina At Wilmington.

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