Job Description

Join to apply for the Medical Writer role at BioSpace 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 #J-18808-Ljbffr BioSpace

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