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.
The Opportunity:
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
Who You Are:
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
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.
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. 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.
#LI-JD1
#ECD
