Principal Medical Writer

Xencor•San Diego, CA

2d•$169,500 - $201,500•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company focused on developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates. The company aims to create high-impact therapeutics for patients with cancer and other serious diseases. This role is a hybrid position requiring 2 days a week on-site in the San Diego, CA office. The Principal Medical Writer will be responsible for preparing clinical and regulatory documents to support Xencor’s clinical development and regulatory submission activities, including INDs, CTAs, BLAs, NDAs, and MAAs.

Requirements

Bachelor’s degree in a physical science, life science, or health-related field such as biology, chemistry, or nursing.
At least 8 years of experience coordinating, authoring, and editing protocols, IBs, CSRs, and other clinical regulatory documents in a pharmaceutical company or CRO environment supporting submissions to U.S. and/or EU health authorities.
Ability to interpret and clearly present scientific and clinical trial data.
Knowledge of statistical analyses.
Excellent technical writing skills.
Knowledge of the drug development process and applicable regulatory guidelines.
Experience working with regulatory agencies and collaborating with senior-level authors and contributors.
Strong project management skills.
Strong interpersonal and communication skills.
Proficiency in Microsoft Word, PowerPoint, and Excel.
Ability to manage multiple priorities in a dynamic environment.
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.

Nice To Haves

An advanced degree is preferred.
Experience in a small-company environment.
Experience with SharePoint, Smartsheet, and Veeva preferred.

Responsibilities

Leads collaboration with functional authors and subject matter experts to develop and update documents in accordance with applicable regulatory guidelines. These documents include, but are not limited to, protocols, protocol amendments, IBs, INDs/CTAs, CSRs, and CSR patient narratives.
Manages document review and approval to ensure timely completion.
Uses document management systems, related tools (including artificial intelligence), templates, and procedures effectively to support efficient authoring, review, and finalization of documents and dossiers.
Collaborates with and oversees contributions from contractors and vendors.
Writes, edits, and performs data verification and consistency checks for clinical regulatory documents.
Project manages, reviews, and edits publications, including manuscripts, abstracts, and poster presentations.
Mentors and coaches less experienced medical writers.
Participates in departmental and cross-functional initiatives.
Contributes ideas and serves as a resource for improving departmental processes.
Provides expertise and guidance on document design and best practices in medical writing.
Adheres to all departmental and company policies related to conduct, performance, and procedures.
Performs other duties as assigned.