CW) Sr Medical Writer (TEMPORARY)

Role Summary

Sr. Medical Writer (Temporary) – Remote (EST or PST hours). The role involves developing medical writing functions within the Worldwide Research And Development organization, supporting regulatory filings, and collaborating with cross-functional teams to ensure documentation quality and regulatory compliance.

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 (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
• 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

• Education: Bachelor’s or higher degree required; scientific focus desirable
• Minimum requirement: Experience in medical writing
• Evidence of medical writing career development desirable (e.g., AMWA/Editor in Life Sciences certificates or related training)
• Experience in medical writing in the pharmaceutical industry
• Clinical Studies: Advanced understanding of drug development, biostatistical and clinical research concepts, clinical study conduct, data collection, database management, data integration, and generation of datasets
• Understanding of nonclinical development, CMC, PK, PD, and antibody detection
• Documentation experience across phases of drug development
• Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; experience with regulatory documents (INDs, BLA/NDAs, PBRERs, DSURs, PAERs) highly preferred; experience with regulatory briefing books preferred
• Proficiency with style guides, medical dictionaries, and regulatory guidance; ability to present complex data clearly
• Understanding of coding dictionaries (MedDRA, WHO Drug)
• Regulatory: Knowledge of regulatory requirements and eCTD workflow (Modules 2, 3, 4, 5); ISS/ISE integration
• Project Management: Ability to manage multiple tasks, lead cross-functional teams, and meet tight timelines; strong conflict resolution and communication skills
• Communication: Clear written and verbal communication with ability to translate complex scientific concepts into regulatory-doc content

Skills

• Microsoft Word, Excel, PowerPoint; Adobe Acrobat
• MS Project/Project Server; document management software (LiveLink, SharePoint, Veeva)
• Regulatory document preparation and review; eCTD experience
• Data presentation (tables/figures); basic clinical laboratory concepts

Education

• Bachelor’s or higher degree; scientific focus desirable
• Experience in medical writing required; certifications/training in medical writing desirable

Additional Requirements

• Remote work; ability to work EST or PST hours