Medical Writer, Genentech
Full Time, South San Francisco, CA
This position works to ensure the consistency and high quality of clinical documents such as protocols, protocol amendments, and Investigator Brochures. This position represents the Development organization and works collaboratively with clinical scientists, biostatisticians, clinical operations representatives, and other personnel to develop clinical protocols from initial concept through first-level review. This position also coordinates the team and functional area first-level review processes, ensures that revisions are incorporated and resolves issues that often require coordination across organizational lines. This position ensures that the documents are written according to internal and external guidelines; anticipates problems, and works proactively with the document authors to solve any problems. This position significantly affects Genentech’s ability to provide high-quality documents to meet corporate and regulatory agency deadlines for clinical trials.
Works closely with clinical scientists, biostatisticians, clinical trial managers, and other key personnel to draft clinical protocols from the concept level; substantively edits, rewrites, and proofreads protocols and other clinical documents; applies expertise gained from earlier documents to current documents and submissions. Ensures high document quality (accuracy, completeness, and internal consistency) and cross-document standardization; acts as a liaison between authors and team reviewers to facilitate departmental and cross-functional processes.
B.A./B.S. degree or higher. Minimum five or more years of medical writing and/or editing experience. Knowledge of biomedical science, biotechnology, pharmaceutical industry, and drug development process. Strong interpersonal skills. Ability to meet tight deadlines, work concurrently on several difficult projects, and shift priorities rapidly. Ability to work with and influence people at all levels of the organization to act in a document’s and/or submission’s best interest.
Contact Joann Casasos, email@example.com