Clinical Documentation Lead

Roche • South San Francisco, CA

8d • $113,800 - $211,400 • Hybrid

About The Position

Become a part of Genentech’s Early Clinical Development team, working to bring pioneering therapies to patients. As a Clinical Documentation Lead in the Medical Communications Group, you will lead medical writing, editing, and project management for the development of clinical documents, including study protocols, informed consent forms, abstracts, manuscripts, and key scientific statements. You will partner closely with cross-functional stakeholders across the Roche organization, including colleagues in Clinical Science, Safety Science, Regulatory, and Clinical Operations.

Requirements

• Eight or more years of medical writing and clinical project management experience, preferably in the biotech/pharmaceutical industry
• Master’s degree or PhD in a scientific or life sciences discipline or liberal arts preferred; or equivalent experience
• Exceptional written and oral communication skills, with a proven ability to communicate effectively with stakeholders across the organization
• Strong project management and team facilitation skills, including the ability to navigate conflicting opinions and build consensus under pressure
• Expertise in clinical, scientific, and/or regulatory writing, with experience leading authoring, review, and finalization of complex documents
• Strong analytical, planning, and organizational skills, with experience prioritizing high-volume workflows, managing simultaneous projects to completion, and ensuring the highest level of accuracy under tight deadlines
• Commitment to collaborative and customer-focused work, demonstrating strong interpersonal skills and the ability to form effective working relationships in a complex, fast-paced environment

Responsibilities

• Oversee the development of clinical protocols, informed consent forms, and other documents by creating and maintaining project timelines; ensuring adherence to internal templates and style guides; writing and editing; coordinating authoring teams and review cycles; managing adjudication of review comments; and coordinating publishing, signoff, and archiving
• Act as a key strategic thinking partner for Clinical Scientists and study teams to align document deliverables with clinical goals
• Acquire and demonstrate a deep understanding of the drug development process, regulatory requirements, and clinical science objectives to effectively guide protocol design and strategy
• Explore AI-based solutions and innovative technologies to optimize medical writing and editing workflows

Benefits

• Discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior