BioMarin Pharmaceutical Inc. is hiring: Principal Clinical Medical Writer in San

Who We Are

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 our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

Our Culture

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

• 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.

• 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. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

• Documentation required for the conduct of clinical studies
• Protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
• Study results reporting
• Integrated results reporting

• Proficient in Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
• Experience using document management software (e.g. SharePoint, Veeva)
• Experienced with scanners, printers, and copiers.

• Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs:

• Standalone regulatory documents (e.g., protocols, investigator brochures, clinical study reports, IND annual reports)

• Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format
• Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)

• Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities.
• Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions
• Ability to support staff in renegotiating timelines during development as necessary.

• Capable of managing and maintaining multiple timelines governing multiple projects within a program.
• Capable of performing resource assessments (short- and long-term) based on projected project needs within a program.
• Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions.

• Capable of well organized, concise and clear written and verbal communication.
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.