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Toniann Derion is a distinguished professional with over two decades of expertise in the biotechnology sector, primarily focusing on the preparation of clinical documents. A proven asset in the field, Derion has been instrumental in the delivery of vital documentation such as protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), briefing documents, manuscripts, and safety narratives. Their proficiency is further underlined by the acquisition of the respected American Medical Writers Association Advanced Curriculum certification.
Armed with a PhD in Kinesiology from the University of Wisconsin-Madison and a background that includes publications in peer-reviewed journals, Derion's commitment to the life sciences is evident in their work. They have a proven track record in collaborating with medical professionals, biostatisticians, and SAS programmers on document development, leading document adjudication meetings, and representing medical writing in clinical study teams.
Currently serving as a Contract Senior Medical Writer with Ascent Services Group in Pleasanton, California, Derion’s role is critical within the IT Services and IT Consulting industry. Their career includes significant positions such as Associate Director and Principal Medical Writer at Astex Pharmaceuticals, and Senior Manager at Roche Molecular Diagnostics, where they managed all medical writing activities for Clinical Affairs. With hands-on experience in managing Clinical Research for Aradigm Corp and as a Project Manager at Covance, Derion has a breadth of experience that spans across several major pharmaceutical and clinical research organizations. Their unique blend of scientific acumen and strategic management in the medical writing domain enhances their remarkable profile.
More about this expert
- Full name
- Toniann Derion
- Location
- Pleasanton, California, United States
- Title
- Contract Sr Medical Writer
- Company
- Ascent Services Group
- Industry
- IT Services and IT Consulting
- LinkedIn profile
- https://www.linkedin.com/in/toniann-derion-phd-els-0728aa6/
- LinkedIn Connections
- 277
- Summary
- More than 20 years experience preparing clinical documents in the biotechnology industry Primary responsibility for delivery of protocols, IBs, CSRs, DSURs, briefing documents, manuscripts, safety narratives American Medical Writers Association Advanced Curriculum certification PhD with publications in peer-reviewed journals Certified by the Board of Editors in the Life Sciences
- Skills
- Life Sciences Oncology
Education
- University of Wisconsin-Madison
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PhD
Attended in 1982 - 1988
Field of study: Kinesiology - The University of Texas at Austin
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M.Ed.
Attended in 1980 - 1982
Field of study: Health
Positions
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Ascent Services Group
Pleasanton, California, United States
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Contract Sr Medical Writer
Jul 2021 - Present
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Astex Pharmaceuticals, Inc.
Pleasanton CA
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Associate Director, Medical Writing
2019 - Jul 2020
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Astex Pharmaceuticals, Inc.
Pleasanton, CA
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Principal Medical Writer
Jul 2013 - Jul 2020
Astex is a leader in innovative drug discovery, development and commercialization, committed to the fight against cancer and other life-threatening diseases. As part of Japan’s leading pharmaceutical company, Otsuka Pharmaceutical Co. Ltd., Astex operates from two sites with drug discovery research headquarters in Cambridge, UK and clinical development headquarters in Pleasanton, California, USA.
- Write and edit protocols & amendments, CSRs, IBs, manuscripts, annual safety reports
- Collaborate with MDs, biostatisticians, SAS programmers on document development
- Lead document adjudication meetings
- Represent medical writing on clinical study teams
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Roche Molecular Diagnostics
Pleasanton CA
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Sr. Manager, Medical Writing
2000 - 2013
Roche Molecular Diagnostics (RMD) offers a uniquely broad range of diagnostic and blood screening assays based on the company's Nobel prize-winning PCR technologies. RMD's tests and automated platforms are focused in the areas of virology, blood screening, HPV, genomics and oncology, microbiology and sexually transmitted infections.
Managed all medical writing activities for Clinical Affairs.
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Aradigm Corp.
Hayward CA
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Manager, Clinical Research
1999 - 2000
Aradigm is an emerging specialty pharmaceutical company developing and commercializing a portfolio of drugs delivered by inhalation for the treatment of severe respiratory disease.
- Wrote study protocols and training materials
- Reviewed literature and prepared written summaries on marketed compounds to support business development efforts
- Managed activities of 3 CRAs in conduct of Phase 2 studies
- Hired and managed CRO for data management and biostatistics
- Represented department on project teams; negotiated study budgets
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Covance
Walnut Creek CA (office closed in 1999)
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Project Manager
1998 - 1999