Meagan Eldridge Email and Phone Number
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.
Eldridge Writing & Consulting Llc
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PresidentEldridge Writing & Consulting Llc Jun 2023 - PresentNorth Carolina, United StatesAuthor 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. -
Senior Director, Regulatory Medical WritingPliant Therapeutics Feb 2023 - Jun 2023Led 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 -
Director, Regulatory Medical WritingPliant Therapeutics Sep 2021 - Feb 2023North Carolina, United States -
Senior Medical WriterWebbwrites, Llc Dec 2018 - Sep 2021Durham, North CarolinaDeveloped 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. -
Medical WriterWebbwrites, Llc Apr 2016 - Dec 2018Raleigh-Durham, North Carolina Area -
Assistant Medical WriterWebbwrites, Llc Apr 2015 - Apr 2016Raleigh-Durham, North Carolina Area -
Medical Writing InternWebbwrites, Llc Dec 2014 - Mar 2015Raleigh-Durham, North Carolina Area -
Graduate Research AssistantUniversity Of North Carolina At Chapel Hill Aug 2012 - Dec 2014Chapel Hill, North CarolinaPrepared 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
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Pharmacology -
Summa Cum Laude With University Honors In Biology
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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