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.

About Worldwide Research and Development
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.

Senior Medical Writer
Hybrid – 2 days per week in London Office
The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

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 (e.g., study team, development team, other sub teams).
• 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

Education & Experience

• Bachelor’s or higher degree required, scientific focus desirable.
• Up to 6 years of as a medical writer in the pharmaceutical industry OR at least 10 years of medical or scientific writing experience as a primary job responsibility.
• Advanced understanding of the drug development process, biostatistical and clinical research concepts, and clinical study conduct.
• Direct experience with documentation in all phases of drug development.
• Experience writing, reviewing, or editing protocols and clinical study reports required.
• Experience with INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.
• Knowledge of regulatory requirements and guidance associated with standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Familiarity with standard eCTD IND/NDA work.

Equal Opportunity Employer/Veterans/Disabled. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.