THUSHARA CARLYON

Davie, FL ***** 973-***-**** adylyr@r.postjobfree.com

Professional Summary

Regulatory Medical Writer with 18 years of experience in writing regulatory clinical documents, managing and planning of US and European health authority submissions for new molecular entities

(NMEs) and biologic license applications (BLAs).

Skills

Motivational Leadership

Plan Projects

Team Leadership

Collaborate Cross-Functionally

Work History

Associate Director 01/2019 to 01/2021

Sarepta Therapeutics

Submission planning; created and managed MW timelines and dossier strategy for the NDA submission and report production

Managed medical writers (contract), and authored integrated summaries of safety, briefing packages for pre-NDA submission meetings, clinical study reports, high level summaries such as Safety (eCTD 2.7.4), and Clinical Overviews (eCTD 2.5) to completed NDA filings Authored protocol amendments

Reviewed and provided feedback on statistical analysis plans and prototype data displays for high level summaries and clinical study reports.

Independent Regulatory Medical Writer 01/2017 to 01/2018 Carlyon Writing LLC

Wrote briefing packages for pre-NDA submission meetings, Clinical Study Reports, Summaries for Clinical Efficacy (2.7.3), Safety (2.7.4), and clinical overviews (2.5) for NDA filings Wrote 3 Phase 1

Protocols.

Principal Medical Writer 01/2013 to 01/2017

Allergan Inc

Managed medical writers, created dossier strategy and authored integrated summaries of efficacy, safety, briefing packages for pre-NDA submission meetings, end of phase 2 meetings, clinical study reports (phase 1 and 3), high level summaries such as Summaries for Clinical Pharmacology, (eCTD 2.7.2)

Efficacy (eCTD 2.7.3), Safety (eCTD 2.7.4), Biopharmaceutics (eCTD 2.7.1) and Clinical Overviews

(eCTD 2.5) for completed NDA filings

Authored clinical sections of INDs including the general investigation plan, phase 3 protocols, abstracts, publications and posters for data resulting from clinical studies Submission planning; created and managed timelines for submissions and report production Reviewed and provided feedback on statistical analysis plans and prototype data displays for high level summaries and clinical study reports.

Independent Regulatory Medical Writer 01/2011 to 01/2013 Carlyon Writing LLC

Wrote briefing packages for pre-NDA submission meeting, advisory committee meetings, end of phase 2 meetings, CSRs, Summaries for Clinical Pharmacology, (2.7.2) Efficacy (2.7.3), Safety

(2.7.4),

Biopharmaceutics (2.7.1) and clinical overviews (2.5) for 3 completed NDA filings Therapeutic areas: oncology, dermatology, cardiovascular (anti-coagulation) and medical devices

Authored protocols for

Phase 1 studies in Alzheimer's and Schizophrenia.

International Document Manager 01/2008 to 01/2011

Roche Pharmaceuticals

Managed medical writers as the lead writer to provide strategy and mentoring in therapeutic areas of oncology, virology and metabolism

Submission planning; created and managed timelines for submissions and report production Created dossier strategy and authored high level summaries such as leCTD 2.7.3 and Safety

(eCTD 2.7.4), and clinical overviews (eCTD 2.5), briefing packages, clinical study reports (phase 1 to 3) for new biologics for FDA and Marketing Applications and Type II variations for EMA

Authored 4-month safety updates and the responses to health authority questions Reviewed and provided feedback on statistical analysis plans and prototype data displays for high level summaries and

CSRs.

Education

Ph.D: Animal Sciences/Protein Biochemistry

Rutgers University - New Brunswick, NJ

M.S: Animal Sciences/Parasitology

Rutgers University - New Brunswick, NJ

B.S: Agricultural Science

Rutgers University - New Brunswick, NJ

Accomplishments

Suresh Sikka, PhD, HCLD, CC (ABB), Thushara Carlyon PhD; Lara Cardinali MS; Vilma Sniukiene MD; Tina deVries, PhD

An evaluation of semen characteristics in men after daily dosing of Udenafil Sexual

Medicines Society of North America, November, 2014

(Poster)

David Portman, MD; Thushara Carlyon, PhD; Heather Thomas, PhD; Kathleen Reape, MD FACOG Efficacy and safety of a new low-dose estradiol vaginal cream administered twice a week for the treatment of vaginal dryness associated with menopause North American Menopause Society, October, 2014

(Poster)

Robin Kroll, MD; Thushara Carlyon, PhD; Heather Thomas, PhD; Kathleen Reape, MD FACOG Efficacy and

Safety of a New Low-Dose Estradiol Vaginal Cream Administered 3 Times a Week for the Treatment of

Dyspareunia Associated with Menopause

North American Menopause Society, October, 2014

(Poster)

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