Gandiva Insights
Overview
Title: Medical Writer
Remote
Responsibilities
Drafts and edits documents used in conducting and reporting the results of clinical studies including protocols protocol amendments informed consent forms and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule such as investigators brochures and periodic safety reports (PBRERs DSURs etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg briefing books eCTD Module 2 / Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents including calling / running meetings developing and managing timelines and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg study team development team other subteams).
Provides peer review and editing support for other regulatory documents such as statistical analysis plans CRFs and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing and may also review / consult on the development of standard processes and templates in other departments
Experience
Up to 6 years of as a medical writer in the pharmaceutical industry
At least 10 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies
Advanced understanding of the drug development process (discovery to market) biostatistical and clinical research concepts clinical study conduct clinical study data collection database management data integration and generation of datasets.
Intermediate to advanced understanding of scientific concepts integral to nonclinical development CMC PK PD and antibody detection.
Intermediate to advanced applied knowledge of : documentation required for the conduct of clinical studies
protocol design (including objectives efficacy and safety endpoints and procedures for collecting and reporting AEs and SAEs)
Direct experience with documentation in all phases of drug development.
Experience writing reviewing or editing protocols and clinical study reports required.
Experience writing reviewing or editing INDs BLA / NDAs PBRERs DSURs and PAERs highly preferred.
Advanced applied knowledge of routine document content preparation including the use of style guides (internal AMA CBE Chicago) medical dictionaries and guidance documents that prescribe content.
Ability to interpret and create complex tabular and graphical clinical data presentations.
Advanced applied knowledge of basic clinical laboratory tests.
Understanding of the concepts of coding dictionaries (MedDRA WHO Drug).
Education
Bachelors or higher degree required scientific focus desirable.
Minimum requirement : Experience in medical writing.
Evidence of medical writing
Key Skills Clinical Research, Adobe Acrobat, FDA Regulations, Technical Writing, Biotechnology, Clinical Development, Clinical Trials, Microsoft PowerPoint, Research Experience, Document Management Systems, Word Processing, Writing Skills
Employment Type :
Full Time
Experience :
years
Vacancy :
1
#J-18808-Ljbffr
Remote
Responsibilities
Drafts and edits documents used in conducting and reporting the results of clinical studies including protocols protocol amendments informed consent forms and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule such as investigators brochures and periodic safety reports (PBRERs DSURs etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg briefing books eCTD Module 2 / Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents including calling / running meetings developing and managing timelines and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg study team development team other subteams).
Provides peer review and editing support for other regulatory documents such as statistical analysis plans CRFs and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing and may also review / consult on the development of standard processes and templates in other departments
Experience
Up to 6 years of as a medical writer in the pharmaceutical industry
At least 10 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies
Advanced understanding of the drug development process (discovery to market) biostatistical and clinical research concepts clinical study conduct clinical study data collection database management data integration and generation of datasets.
Intermediate to advanced understanding of scientific concepts integral to nonclinical development CMC PK PD and antibody detection.
Intermediate to advanced applied knowledge of : documentation required for the conduct of clinical studies
protocol design (including objectives efficacy and safety endpoints and procedures for collecting and reporting AEs and SAEs)
Direct experience with documentation in all phases of drug development.
Experience writing reviewing or editing protocols and clinical study reports required.
Experience writing reviewing or editing INDs BLA / NDAs PBRERs DSURs and PAERs highly preferred.
Advanced applied knowledge of routine document content preparation including the use of style guides (internal AMA CBE Chicago) medical dictionaries and guidance documents that prescribe content.
Ability to interpret and create complex tabular and graphical clinical data presentations.
Advanced applied knowledge of basic clinical laboratory tests.
Understanding of the concepts of coding dictionaries (MedDRA WHO Drug).
Education
Bachelors or higher degree required scientific focus desirable.
Minimum requirement : Experience in medical writing.
Evidence of medical writing
Key Skills Clinical Research, Adobe Acrobat, FDA Regulations, Technical Writing, Biotechnology, Clinical Development, Clinical Trials, Microsoft PowerPoint, Research Experience, Document Management Systems, Word Processing, Writing Skills
Employment Type :
Full Time
Experience :
years
Vacancy :
1
#J-18808-Ljbffr