CW) Sr Medical Writer (TEMPORARY)

Role Summary

Sr. Medical Writer (Temporary) working remotely, with options for EST or PST hours. The role involves developing and managing medical writing activities for clinical development, ensuring high-quality documentation and regulatory-ready materials across development stages.

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 (e.g., 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 (e.g., study team, development team, other subteams)
• Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
• 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
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
• Works effectively with cross-functional groups within BioMarin
• Other tasks as assigned

Qualifications

• Bachelor’s or higher degree required; scientific focus desirable
• Minimum requirement: Experience in medical writing
• Evidence of medical writing career development desirable (e.g., specific certificates or training)
• Up to 6 years of as a medical writer in the pharmaceutical industry or at least 10 years of medical or scientific writing experience as a primary job responsibility
• Direct experience with documentation in all phases of drug development

Experience

• Clinical Studies: Advanced understanding of the drug development process, biostatistical and clinical research concepts, clinical study conduct, data collection, database management, data integration, and dataset generation
• Nonclinical/CMC/PK/PD: Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
• Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; preferred experience with INDs, BLA/NDAs, PBRERs, DSURs, PAERs; preferred regulatory briefing books; strong drafting/editing skills and ability to interpret complex data presentations; familiarity with coding dictionaries (MedDRA, WHO Drug)
• Computer/Office Skills: Proficient in Word, Excel, PowerPoint; experience with document management software (LiveLink, SharePoint, Veeva); familiarity with scanners/printers/copiers
• Regulatory: Knowledge of regulatory requirements for standalone regulatory documents; familiarity with eCTD modules 2, 3, 4, 5, ISS/ISE
• Project Management: Ability to manage multiple tasks, lead cross-functional teams, manage timelines and review processes, and resolve cross-functional conflicts
• Communication: Clear written and verbal communication; ability to translate complex concepts into regulatory-compliant text; strong presentation skills

Education

• Bachelor’s degree or higher; scientific focus desirable

Additional Requirements

• Distance/Remote work: No in-person requirement specified beyond remote work and time-zone alignment