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C Loch

@cloch

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Medical writer at ICON, plc authoring eCTD submissions for oncology and rare disease therapeutics.

United States

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At ICON, plc, I lead project teams developing regulatory submission documents, including eCTD Modules 2 and 5, clinical study reports, and agency responses. I author documents, facilitate reviews, and mentor junior medical writers.

Previously, I led clinical development and medical writing work at GlaxoSmithKline, including registration studies for a novel NSCLC treatment and regulatory documents supporting oncology submissions. I’ve also developed templates, style guides, and training materials to support regulatory writing and clinical study processes.

Experience

Work history, roles, and key accomplishments

Current

Principal MW

Current

ICON, plc

Feb 2017 - Present (9 years 9 months)

Lead project teams in the development and finalization of regulatory submission documents, including independent authoring, team review facilitation, and edit/update implementation. Mentor and develop training to support junior medical writers.

Regulatory Writing eCTD Clinical Study Report (CSR)Investigator Brochures Medical Writing Team Leadership Mentorship Training and Development

Clinical Program Manager

Advanced Clinical

Aug 2015 - Feb 2017 (1 year 6 months)

Managed the conduct of clinical studies and provided oversight of over 16 direct reports. Mentored and managed teams through risk identification and mitigation strategies, ensuring timelines and quality were not compromised.

Clinical Operations Team Management Risk Management Mentorship Sponsor Management

Senior MW Manager, Scientific Writing

Discovery Labs

May 2013 - Dec 2015 (2 years 7 months)

Authored clinical and preclinical INDs, IBs, study training documents, study protocols and supporting documents. Developed and conducted training on ICH-GCP-based SOPs and study processes to support first-in-human studies for a novel device and drug combination.

Medical Writing IND Investigator Brochures Protocols ICH GCP SOPs Training

Medical Writer Consultant

Daiichi-Sankyo Pharmaceutical Development

May 2012 - Dec 2012 (7 months)

Supported NDA submission for an investigational cardiovascular agent by developing and authoring documents outlining the conduct, challenges, and study governance of two pivotal Phase 3 studies. Assisted in overall submission planning.

Medical Writing NDA Submission Expertise Clinical Trials (Phase 3)Regulatory Documentation

Manager, Oncology MW Program Team

GlaxoSmithKline

Mar 2011 - Jan 2012 (10 months)

Global Lead for development and delivery of key regulatory documents for a marketed agent for the treatment of hemolytic malignancies. Led teams in the development and execution of timings and budgets for document deliverables to support NDA and sNDA submissions.

Medical Writing Regulatory Documentation NDA SNDA Team Leadership Budget Management

Manager, Oncology Development

GlaxoSmithKline

Apr 2008 - Mar 2011 (2 years 11 months)

Global Clinical Investigational Lead for the development and execution of a registration program for a novel treatment in NSCLC. Collaborated with external experts and internal stakeholders in the development of study proposals and led Phase 1 team in the development and execution of Phase 1 studies.

Clinical Development Oncology Phase I Stakeholder Management Study Proposals

Lead Clinical Scientist, Oncology

GlaxoSmithKline

Feb 2006 - Apr 2008 (2 years 2 months)

Led the authoring of submission documents and associated agency response documents. Developed and managed collaborative research programs for investigator-initiated research studies and developed a charter and associated processes for a therapeutically aligned protocol review forum.

Clinical Science Regulatory Submissions Investigator Initiated Trials Review Protocol

Senior Clinical Scientist, Oncology

GlaxoSmithKline

Jan 2003 - Feb 2006 (3 years 1 month)

North American Clinical Lead for supportive care compounds in the oncology setting; collaborated with key internal and external stakeholders in the creation of clinical development plans, study budgets, timelines, and protocols. Developed and facilitated nursing and physician advisory boards.

Clinical Development Oncology Supportive Care Clinical Development Plans Advisory Board CRF Design

Clinical Data Scientist

GlaxoSmithKline

Jul 2001 - Jan 2003 (1 year 6 months)

Key member of the pharmaceutical research team responsible for the oversight, review, and validation of clinical data. Programmed basic Access/SQL queries for remote data management, assisted with monitor training in electronic data capture, and performed dictionary encoding and serious adverse event reconciliation.

Clinical Data Management SQL Access Electronic Data Capture Serious Adverse Event Reconciliation Mentorship