Senior Medical Writer - Remote

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 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

• Bachelor's or higher degree required, scientific focus desirable.
• Minimum requirement: Experience in medical writing.
• Evidence of medical writing