PhD level Pharmaceutical Regulatory Writer
Resume:
Experience Grid example (*) date
Please complete the 4 tables below with requested information about your role in document preparation in the last several years. For CTD sections, please indicate whether IND or NDA.
One line per Document type/Therapeutic Area as we are looking for document experience in a Therapeutic area. Add lines as needed. Date Completed: 4 June 2023
Primary author last 3 yrs Number Written Phase Therapeutic area Primary author 3+
years Number Written Phase Therapeutic Area
Protocol and Amendment 10 I, II, III
Solid tumors (e.g.,
sarcomas, carcinomas)
Protocol and
Amendment 10 I, II, III
Solid tumors (e.g., sarcomas,
carcinomas)
Investigator brochure 10 I, II, III
Liquid tumors (e.g.,
leukemias, lymphomas) Investigator brochure 10 I, II, III Liquid tumors (e.g., leukemias,
lymphomas)
Investigational Medicinal Product Dossiers 20 I, II, III Coronary heart disease,
stroke
Investigational
Medicinal Product
Dossiers 3 I, II, III Coronary heart disease, stroke Clinical study report and Non-interventional
Study Reports 20 I, II, III Anemia
Clinical study report
and Non-interventional
Study Reports 20 I, II, III Anemia
Clinical overview (2.5) 6 III Severe aplastic anemia Clinical overview (2.5) 6 III Severe aplastic anemia Clin summary of efficacy (2.7.3) 6 III Chronic kidney disease Clin summary of
efficacy (2.7.3) 6 III Chronic kidney disease
Clin summary of safety (2.7.4) 6 III Schizophrenia Clin summary of safety
(2.7.4) 6 III Schizophrenia
Integrated summary of efficacy (5.3.5.1) 6 III
Amyotrophic lateral
sclerosis (ALS)
Integrated summary of
efficacy (5.3.5.1) 6 III Amyotrophic lateral sclerosis (ALS) Integrated summary of safety (5.3.5.2) 6 III Alzheimer's disease Integrated summary of
safety (5.3.5.2) 6 III Alzheimer's disease
Other regulatory document (please list):
Other regulatory
document (please list):
Briefing Documents 20 I, II, III Parkinson's disease Briefing Documents 20 I, II, III Parkinson's disease Regulatory Responses 7 I, II, III Multiple sclerosis Regulatory Responses 7 I, II, III Multiple sclerosis RMP 0 RMP 0
Contributing writer last 3 yrs Number Written Phase Therapeutic area Contributing writer 3+
yrs Number Written Phase Therapeutic Area
Protocol and Amendment 15 I, II, III
Oncology/Immunology/
Hematology
Protocol and
Amendment 15 I, II, III Oncology/Immunology/Hematology Investigator brochure 20 I, II, III
Oncology/Immunology/
Hematology Investigator brochure 20 I, II, III Oncology/Immunology/Hematology Clinical study report and Non-interventional
Study Reports 12 I, II, III
Oncology/Immunology/
Hematology
Clinical study report
and Non-interventional
Study Reports 12 I, II, III Oncology/Immunology/Hematology Clinical overview (2.5) 8 III
Oncology/Immunology/
Hematology Clinical overview (2.5) 8 III Oncology/Immunology/Hematology Clin summary of efficacy (2.7.3) 8 III
Oncology/Immunology/
Hematology
Clin summary of
efficacy (2.7.3) 8 III Oncology/Immunology/Hematology Clin summary of safety (2.7.4) 8 III
Oncology/Immunology/
Hematology
Clin summary of safety
(2.7.4) 8 III Oncology/Immunology/Hematology
Integrated summary of efficacy (5.3.5.1) 8 III
Oncology/Immunology/
Hematology
Integrated summary of
efficacy (5.3.5.1) 8 III Oncology/Immunology/Hematology Integrated summary of safety (5.3.5.2) 8 III
Oncology/Immunology/
Hematology
Integrated summary of
safety (5.3.5.2) 8 III Oncology/Immunology/Hematology Other regulatory document (please list):
Briefing Documents 20 I, II, III
Oncology/Immunology/
Hematology Briefing Documents 20 I, II, III Oncology/Immunology/Hematology Regulatory Responses 10 I, II, III
Oncology/Immunology/
Hematology Regulatory Responses 10 I, II, III Oncology/Immunology/Hematology RMP 0 I, II, III RMP 0
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