Job Description

Join to apply for the Medical Writer role at BioSpace . 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 various treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of candidates that have well-understood biology and offer potential first-to-market or substantial benefits. About Worldwide Research And Development Our WWRD engine involves all bench and clinical research and support groups, working on developing first-in-class and best-in-class therapeutics for genetic diseases. Note: This description is not all-inclusive and duties may vary. Equal Opportunity Employer/Veterans/Disabled We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. Hybrid (1-2 days in office) . We seek regulatory medical writers (not Medical Communication). The Contract Medical Writer will assist in developing, drafting, reviewing, editing, and finalizing documents for clinical studies and regulatory submissions. Responsibilities include: Drafting and editing documents for submissions (CTDs, RtQs) Drafting and editing clinical study documents (protocols, amendments, informed consent forms) Reporting safety and efficacy data (investigator’s brochures, safety reports) Managing study team participation, timelines, and review processes Adhering to departmental standards and industry practices Collaborating with cross-functional teams Supervisory responsibilities: None. Contact with Clinical Medical Writing, Biostatistics, Data Management, and other departments. Skills required: Medical writing experience in the pharmaceutical industry Minimum 5 years experience Knowledge of drug development, clinical protocols, and documentation Experience with protocols, INDs, BLA/NDAs (preferred) Proficiency in Microsoft Word, Excel, PowerPoint Strong organizational, communication, and scientific interpretation skills Education: Bachelor’s degree or higher, scientific focus preferred. Medical writing certification or relevant training is desirable. Seniority level: Mid-Senior level Employment type: Full-time Job function: Medical Writing, Regulatory Affairs Note: The job posting is active and not expired. #J-18808-Ljbffr BioSpace

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