BioSpace is hiring: Principal Clinical Medical Writer in San Rafael

The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents. RESPONSIBILITIES Oversight responsibilities for Medical Writing staff Works with the Head of Medical Writing to establish and maintain timelines for program planning. 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 (e.g. PBRERs, DSURs) Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams). Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments Works effectively with cross-functional groups within BioMarin Other tasks as assigned. SCOPE This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. EDUCATION Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: Regulatory At least 8 years of experience as a medical writer in the pharmaceutical industry. Experience with delegating and overseeing projects and tasks. 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. Writing high-quality documents that support corporate goals and objectives. Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr