Clinical Documentation Lead

Posted 22 Hours Ago
Be an Early Applicant
South San Francisco, CA, USA
In-Office
114K-211K Annually
Senior level
Healthtech • Biotech
The Role
Lead medical writing, editing, and project management for clinical documents (protocols, ICFs, abstracts, manuscripts). Coordinate authoring teams, review cycles, timelines, stakeholder alignment, publishing, and regulatory-compliant documentation. Provide strategic input on protocol design and explore AI tools to optimize workflows.
Summary Generated by Built In

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.

Skills Required

  • Eight or more years of medical writing and clinical project management experience
  • Experience leading authoring, review, and finalization of complex clinical and regulatory documents
  • Exceptional written and oral communication skills
  • Strong project management and team facilitation skills, including managing review cycles and adjudication
  • Deep understanding of drug development process and regulatory requirements
  • Ability to prioritize high-volume workflows and manage simultaneous projects to completion under tight deadlines
  • Commitment to collaborative, customer-focused work and strong interpersonal skills
  • Master's degree or PhD in a scientific or life sciences discipline or liberal arts, or equivalent experience
  • Experience in the biotech or pharmaceutical industry (preferred)
  • Onsite presence on South San Francisco campus at least three days per week

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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