CW) Sr Medical Writer (TEMPORARY)

Role Summary

Sr. Medical Writer (Temporary) – Remote. Can work EST or PST hours.

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‚Äôs 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

• Education: Bachelor‚Äôs or higher degree required; scientific focus desirable. Minimum requirement: Experience in medical writing. Evidence of medical writing career development desirable (e.g., AMWA certificate, Editor in Life Sciences certificate, or relevant training).
• Experience: Relevant experience; Fulfills one of the following:
  • 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, biostatistical and clinical research concepts, clinical study conduct, data collection, database management, data integration, and dataset generation; knowledge of nonclinical development, CMC, PK, PD, and antibody detection; experience with documentation in all phases of drug development; protocol design and study results reporting
• Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; experience with INDs, BLA/NDAs, PBRERs, DSURs, and PAERs; experience with regulatory briefing books; proficiency with style guides and clinical data presentation; understanding of coding dictionaries (MedDRA, WHO Drug)
• Computer/Office Skills: Proficient in Word, Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint; experience with document management software (LiveLink, SharePoint, Veeva)
• Regulatory: Knowledge of regulatory requirements for standalone regulatory documents; familiarity with eCTD work (Modules 2, 3, 4, 5) and ISS/ISE
• Project Management: Ability to manage multiple tasks and priorities; experience leading cross-functional teams under tight timelines; strong conflict resolution and initiative
• Communication: Clear written and verbal communication; ability to translate complex science into regulatory-compliant text; strong presentation skills

Skills

• Strong scientific writing and editing skills
• Regulatory document preparation and review
• Cross-functional collaboration and meeting leadership
• Attention to detail and regulatory compliance
• Effective communication and project management

Education

• Bachelor‚Äôs degree or higher; scientific focus desirable
• Certificate or training in medical writing or related field is a plus