Clinical Documentation Lead

About the role

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.

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

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 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

Qualifications

• Onsite presence on our South San Francisco campus is expected for at least 3 days a week
• Relocation benefits are not available for this job posting

Skills

• Experience in medical writing and clinical project management
• Understanding of the drug development process, regulatory requirements, and clinical science objectives
• Expertise in clinical, scientific, and/or regulatory writing
• Strong project management and team facilitation skills
• Ability to navigate conflicting opinions and build consensus under pressure
• Experience in AI-based solutions and innovative technologies

Benefits

• The expected salary range for this position based on the primary location of California is $113,800 - $211,400
• A discretionary annual bonus may be available based on individual and Company performance
• This position also qualifies for the benefits detailed at the link provided below

Pay

The expected salary range for this position based on the primary location of California is $113,800 - $211,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Schedule

Onsite presence on our South San Francisco campus is expected for at least 3 days a week.

Link for Benefits

Detailed information about benefits

Equal Opportunity Employer

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.