Clinical Documentation Lead

Genentech; South San Francisco (CA); On-site; USD 113,800 - 211,400; Full time

Job summary

Genentech is seeking a Clinical Documentation Lead in the Medical Communications Group to drive medical writing, editing, and project management for protocols, informed consent forms, and manuscripts. You will partner with Clinical Science, Regulatory, Safety and Clinical Operations to align documents with study goals.

Ideal candidates have 8+ years in medical writing and biotech project management, advanced scientific training, and strong communication, planning, and consensus-building skills

Qualifications

• Eight or more years of medical writing and clinical project management experience.
• Master’s degree or PhD in a scientific discipline or related field.
• Exceptional written and oral communication skills with stakeholders across the organization.
• Strong PM and facilitation skills to navigate conflicting opinions and build consensus.
• Expertise in clinical, scientific and regulatory writing for complex documents.
• Ability to prioritize high-volume workflows and meet tight deadlines.

Responsibilities

• Oversee development of clinical protocols, informed consent forms, and other documents by creating and maintaining project timelines; coordinating authoring teams and review cycles; and archiving.
• Act as a strategic thinker for Clinical Scientists to align documents with clinical goals.
• Guide protocol design and strategy with an understanding of drug development and regulatory requirements.
• Explore AI-based solutions to optimize medical writing and editing workflows.

Skills

Medical writing

Clinical project management

Stakeholder communication

Regulatory writing

Team facilitation

Education

Master’s or PhD in life sciences or related field

Job description

The Position

We advance science so that we all have more time with the people we love.

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.

Benefits

#LI-JD1

#ECD

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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.