BioSpace
BioSpace is hiring: Medical Writer in San Rafael
BioSpace - San Rafael, CA, United States, 94911
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Overview
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Overview
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BioSpace is seeking a qualified Medical Writer to join our team. The role involves developing and editing documents used in clinical studies and regulatory submissions, with a focus on regulatory medical writing (not Medical Communication). This position is hybrid, requiring 1-2 days in the office.
Responsibilities
- Draft and edit documents for submissions including CTDs and RtQs
- Prepare documents for clinical study reports, protocols, amendments, and informed consent forms
- Report aggregate safety and efficacy data, such as investigator’s brochures and safety reports
- Manage study team participation in document preparation, timelines, and review processes
- Adhere to departmental procedures and industry standards
- Collaborate with cross-functional teams within BioMarin
Qualifications
- At least 5 years of experience in medical or scientific writing within the pharmaceutical industry
- Familiarity with drug development, clinical study documentation, and reporting
- Experience with protocols, clinical study reports, INDs, and BLA/NDAs preferred
- Proficiency in Microsoft Word, Excel, PowerPoint, and document style guides
- Ability to interpret clinical data and create tables and summaries
- Understanding of regulatory requirements for clinical documents
- Strong organizational, communication, and conflict management skills
Education
- Bachelor’s degree or higher, scientific focus preferred
- Relevant medical writing certifications or training is desirable
Additional Information
- Seniority level: Mid-Senior level
- Employment type: Full-time