Director - Medical Writing
September 5
🏡 Remote – Anywhere in California
Description
• Independently writing and delivering high-quality clinical and regulatory documents • Coordinating effective document development, review, and approval • Overseeing medical writing vendor writers for individual projects • Actively contributing to development of processes and procedures to improve departmental and cross-functional workflows • Building relationships and working collaboratively with study team members and CRO/FSP partners • Reviewing study and program-level documents for clarity, accuracy, and consistency • Developing in-depth study-level and program knowledge • Contributing scientific knowledge and analytical skills to the production of documents • Participating in developing key messages for clinical regulatory documents • Developing document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables • Leading development of clinical trial registry postings for assigned studies • Navigating an electronic document management system and related tools to develop clinical documents
Requirements
• Bachelor's degree in biomedical science required, • 10+ years of experience in the pharmaceutical/biotechnology industry as a medical writer and line manager • Self-motivated and nimble with the ability to excel in a fast-paced environment • Excellent written and verbal communication skills • Strong interpersonal skills • Experience producing high-quality scientific/medical documents • Ability to analyze, interpret, and summarize clinical data • Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology • Strong project management and organizational skills • Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department • Attention to detail related to consistency, grammar, syntax, and scientific accuracy • Proficiency in word processing, templates, table/figure creation, and literature searches
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