Jobs via Dice
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 investigator’s 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 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, including protocol design (objectives, efficacy and safety endpoints, 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 coding dictionaries (MedDRA, WHO Drug)
Education
Bachelor’s or higher degree required, scientific focus desirable
Minimum requirement: Experience in medical writing
Evidence of medical writing
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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 investigator’s 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 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, including protocol design (objectives, efficacy and safety endpoints, 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 coding dictionaries (MedDRA, WHO Drug)
Education
Bachelor’s or higher degree required, scientific focus desirable
Minimum requirement: Experience in medical writing
Evidence of medical writing
#J-18808-Ljbffr