Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I -IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!

Principal Medical Writer formulates writing strategy for assigned regulatory submissions or key projects (e.g. response documents). Guides document preparation, including coordination of assignments to Cytel and contract writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for the preparation of key regulatory response documents and documents supporting major regulatory submissions. Formulates writing approach for assigned regulatory submissions and projects. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation and production, including the US and international regulatory guidelines and requirements for content and format, Cytel requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.

JOB RESPONSIBILITIES:

• Plans and prepares a variety of clinical documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents includeprotocols, clinical study reports, patient narratives, IND submissions, integrated summary reports, annual reports, investigator brochures, clinical development plans, NDA and (e)CTD submissions, manuscripts, abstracts, client presentations. etc.
• Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.
• Performs quality control (QC) review of clinical study reports and other submissions written by other medical writers
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Liaise with other functional groups (e.g. data management, statistical programming, biostatistics, project management, and publishing vendors) to ensure timely delivery and quality of writing deliverables.
• Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
• Prepares documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence to regulatory requirements and Cytel requirements and processes.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• As required, serves as the lead writer for important regulatory response documents and key components of regulatory submissions.
• Keeps management informed on progress of documents and other project related activities, assist management in projecting efforts, and perform administrative duties as requested.
• Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Effectively delegates and intervenes as required to maintain optimal productivity.
• Provides leadership on functional teams that address requirements or issues related to document preparation and reviewand coordinate activities of other personnel in the team.

QUALIFICATIONS:

Education: Bachelor’s/Master’s degree in a life science-related discipline

Experience:

• Minimum 8-10 years of pharmaceuticals, biotech, or CRO medical writing experience.

Skills:

• Working knowledge of ICH and other regulatory guidelines.
• A clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
• Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Writing (e.g., English usage) and keen attention to detail also are required.
• Must have excellent verbal/written communication skills and excellent presentation skills
• Experience in a medical content generation is preferred
• Excellent interpersonal and conflict resolution skills
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner

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