Medical Writer

About the role

The Medical Writer 1 assists 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.)
• 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

Requirements

• Proficient in Microsoft Word (including the use of templates), 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 (eg, protocols, investigator brochures, and clinical study reports)
• 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 that meets regulatory requirements
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills

Qualifications

• Bachelor's Degree

Skills

• Strong writing and editing skills
• Knowledge of regulatory guidelines and standards
• Experience with clinical trial documentation
• Ability to manage multiple projects simultaneously
• Excellent communication and interpersonal skills

Benefits

At BioMarin, we are committed to providing competitive benefits to our employees. These benefits include:

• Health insurance
• Retirement savings plan
• Flexible spending accounts
• Employee assistance program
• Parental leave
• Generous paid time off

Pay

Compensation is commensurate with experience.

Schedule

This is a full-time position.