Sr Medical Writer

Job Responsibilities

• Act as a project lead and author clinical development documents, including but not limited to, clinical protocols, investigator s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Modules 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5, presentation materials and publications to medical journals
• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the relevant clinical/scientific data sources to develop high-quality deliverables
• Complete project assignments per timelines
• Maintain timelines and workflow of writing assignments
• Practice excellent internal and external customer service, communication, and teamwork.
• Highly proficient with document templates, MW tools and style guides for authoring various regulatory deliverables
• Interact directly and independently with client to coordinate all facets of projects; manage full project lifecycles, including client meetings, KOMs and CRMs
• Identify and mitigate project risks
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Job Requirements

• At least 5 years of previous experience in the Pharma/CROindustry
• Must have at least 5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial experience as lead author on clinical study protocols and clinical study reports
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in authoring regulatory submissions documents for INDs, NDAs, or MAAs a plus
• Strong understanding and ability to interpret clinical data
• Exceptional writing and communication skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, related word processing tools, and must have worked on document management systems
• Experience being a project lead, and managing a project team a must
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
• Flexible to work with clients in different time zones

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