Medical Writer Job at BioMarin Pharmaceutical (San Rafael)

Medical Writer

BioMarin Pharmaceutical

Location:
United States , San Rafael

Category:
Research and Development

Contract Type:
Not provided

Salary:

74100.00 - 100000.00 USD / Year

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Job Description:

The Medical Writer 1 applies basic to intermediate 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.

Job Responsibility:

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.)
Aids in managing 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
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 Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned

Requirements:

Bachelor’s or higher degree preferred
scientific focus desirable
University-level medical or technical writing course(s) or equivalent experience in science/technical writing
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association
Up to 2 years as a medical writer in the pharmaceutical industry OR At least 5 years of medical or scientific writing experience as a primary job responsibility
Familiar with drug development process (discovery to market)
Basic understanding of biostatistical and clinical research concepts
Basic applied knowledge of documentation required for the conduct of clinical studies
Basic applied knowledge of protocol design
Basic applied knowledge of study results reporting
Writing high-quality documents that support corporate goals and objectives
Experience writing, reviewing, or editing protocols and clinical study reports preferred
Basic applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents
Ability to interpret basic tabular and graphical clinical data presentations
Ability to create basic tables using AMA style
Basic to intermediate applied knowledge of basic clinical laboratory tests
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Proficient in Microsoft Word, Excel, Adobe Acrobat, and PowerPoint
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers
Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents
Capable of working on multiple tasks and shifting priorities
Good conflict management skills
Motivated and shows initiative
Detail oriented
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
Effective at explaining writing principles to a varied audience both in individual and group settings
basic presentation skills

Nice to have:

Evidence of medical writing career development desirable
Experience writing, reviewing, or editing protocols and clinical study reports preferred

What we offer:

discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans

Additional Information:

Job Posted:
February 13, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

BioMarin Pharmaceutical - All Job Offers

Job Link Share:

Medical Writer

BioMarin Pharmaceutical

Location:
United States , San Rafael

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 13, 2026

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