Mark G. Sobnosky
Mark has over 20 years of medical writing experience with clinical and regulatory documents. With his expertise as a writer, editor, word processor, and QC reviewer, and his ability to create and manage writing teams, he is able to deliver quality services to clients with needs ranging from study reports to NDAs.
Owner, Principal Writer
Summit Medical Writing Group
Expertise
Experience
Triangle Research Communications Senior Medical Writer and Regulatory Consultant
Aerotek Scientific Senior Medical Writer and Regulatory Consultant
Image Solutions, Inc. Senior Medical Writer
BCH Medical Writing Owner, Contract Medical Writing Services
Schwarz BioSciences, Inc. Senior Medical Writer
EMD Pharmaceuticals, Inc. Assistant Director, Medical Writing Services
Ardent Pharmaceuticals, Inc. Medical Writer
Quintiles, Inc. Regulatory Scientist II - Regulatory and Technical Services; Senior Manager of Business Development - Medical and Regulatory Services; Associate Clinical Research Scientist - Department of Clinical Sciences; Clinical Research Specialist - Department of Medical Affairs
Image Solutions, Inc. Senior Medical Writer
BCH Medical Writing Owner, Contract Medical Writing Services
Schwarz BioSciences, Inc. Senior Medical Writer
EMD Pharmaceuticals, Inc. Assistant Director, Medical Writing Services
Ardent Pharmaceuticals, Inc. Medical Writer
Quintiles, Inc. Regulatory Scientist II - Regulatory and Technical Services; Senior Manager of Business Development - Medical and Regulatory Services; Associate Clinical Research Scientist - Department of Clinical Sciences; Clinical Research Specialist - Department of Medical Affairs
• Clinical Study Reports (Phases I-IV)
• Integrated Summaries of Safety & Efficacy
• Clinical summary sections of CTDs
• Investigator's Brochures
• Protocols
• 120-Day Safety Updates
• Patient Narratives
• Clinical Development Plans
• End of Phase II Summaries
• IND Annual Reports
• Sample Informed Consent Forms
• European Annual Safety Reports
• IMPDs
• SOPs
• Style guides
• QC checklists
• Integrated Summaries of Safety & Efficacy
• Clinical summary sections of CTDs
• Investigator's Brochures
• Protocols
• 120-Day Safety Updates
• Patient Narratives
• Clinical Development Plans
• End of Phase II Summaries
• IND Annual Reports
• Sample Informed Consent Forms
• European Annual Safety Reports
• IMPDs
• SOPs
• Style guides
• QC checklists
Therapeutic Areas
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Respiratory and allergy: asthma, pneumonia, rhinitis
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Central Nervous System: migraines, depression, obsessive compulsive disease, seasonal affective disorder, multiple sclerosis, Alzheimer’s disease, anti-psychotics, epilepsy, analgesics
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Urology: benign prostate hyperplasia
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Bone Disease: arthritis, osteoporosis
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Infectious Disease: antibiotics, immunoglobulins, Human Immunodeficiency Virus
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Cardiovascular/Stroke: anticoagulants, heparinoids
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Intermittent Claudication
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Ophthalmology: glaucoma
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Blood Products: plasma expanders, red blood cell replacement products
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Dermatology: psoriasis, allergic dermatitis
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Oncology (chemotherapeutics and IL-2 therapy): lymphoma, melanoma, prostate cancer
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Gastrointestinal and metabolic: gastro-esophageal reflux disease, Type II diabetes, peritoneal dialysis solutions
Master of Science – Biochemistry
University of North Carolina at Chapel Hill, Chapel Hill, NC
University of North Carolina at Chapel Hill, Chapel Hill, NC
Bachelor of Science
University of Houston, Houston, TX
Education
American Medical Writers Association (AMWA)
Alpha Chi Sigma Professional Chemistry Fraternity (ACS)
Drug Information Association (DIA)
Professional Organizations
