CDI Inc., is looking for qualified candidates to fill the role of Technical Document Writer - Clinical Documentation. This is expected to be 12 month+ project in duration. This would be a W2 position and you would work onsite at client’s location in Mountain View, CA then San Francisco. Please review the project description provided, and let me know if this is something you might be interested in discussing further.

Responsibilities

Position will start in MTV and then be moving to South San Francisco

Work with various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator's brochures, etc., according to company and agency guidelines in order to support company goals under strict timelines.

Top 3 Daily Responsibilities

• Create documents, and reviews for clinical and regulatory documents (e.g., protocol, CSR, IB, and marketing materials, periodic annual reports, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format
• Ensure a consistent style of presentation of documents to maintain quality and ease of review
• Lead team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices

Additional responsibilities

• Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.

Requirements

• 10 years experience with BS (Science or english degree preferred otherwise manager is open to area of study as long as they have appropriate work experience), as a medical writer
• Working knowledge of product development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
• Detailed knowledge of requirements for preparation of key clinical and regulatory documents - Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment
• Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines

Nice to have

• MS Preferred (Science or english degree preferred otherwise manager is open to area of study as long as they have appropriate work experience), with 5 years experience as a medical writer
• Manager prefers candidates with startup experience