Overview
Join to apply for the Principal Clinical Medical Writer role at BioMarin Pharmaceutical Inc.
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, we have applied our scientific expertise to create transformative medicines for genetic conditions, with a diverse pipeline across commercial, clinical and preclinical programs.
Our culture brings together people with the right technical expertise and a relentless drive to solve real problems, empowering teams to pursue bold, innovative science. We develop first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Our WWRD engine involves all bench and clinical research and the groups that support those endeavors.
Summary Description
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
* Work 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 for regulatory filings (e.g., briefing books, CTD Module 2/Module 5 clinical or integrated summaries)
* Manages study team participation in preparing such documents, including scheduling and chairing meetings, developing/managing timelines, and managing the document review and comment adjudication processes
* Represents Clinical Medical Writing at cross-functional team meetings (study team, development team, and other sub-teams)
* Provides peer review and editing support for regulatory documents, such as statistical analysis plans, CRFs, and other study materials
* Adheres to departmental procedures, technical and industry standards
* Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may review/consult on standard processes/templates in other departments
* Works effectively with cross-functional groups within BioMarin
* Other tasks as assigned
Education and Experience
Education
Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: at least 8 years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable (e.g., certification from recognized societies or relevant training).
Experience
* At least 8 years of experience as a medical writer in the pharmaceutical industry
* Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required
* Demonstrated leadership abilities and ability to plan timelines/resources for multiple documentation projects
* Experience delegating and overseeing projects and tasks
Clinical Studies and Medical Writing Skills
* Advanced understanding of the drug development process, biostatistical and clinical research concepts, clinical study conduct, data collection, database management, and data integration
* Understanding of nonclinical development, CMC, PK, PD, and antibody detection
* Ability to write/edit protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books
* Experience with style guides (internal/ AMA/ CBE/ Chicago), medical dictionaries, and regulatory guidance documents
* Ability to interpret and present complex clinical data and to interpret clinical laboratory tests; understanding of coding dictionaries (MedDRA, WHO Drug)
Computer and Regulatory Skills
* Proficient in Microsoft Word, Excel, PowerPoint, Project; Acrobat; knowledge of document management platforms (e.g., SharePoint, Veeva)
* Experience with regulatory submissions (eCTD modules 2, 3, 4, and 5) and preparation of regulatory documents
Project and Program Management
* Ability to plan, resource, and manage multiple document development projects with shifting priorities
* Strong organizational and communication skills; ability to manage timelines and report status to line management
Equal Opportunity
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, protected veteran status or disability.
Note
This description is not intended to be all-inclusive or a limitation of duties and may include other duties as assigned.
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