Principal Medical Writer

Introduction:Xencor•San Diego, CA

1d•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Principal Medial Writer to join our team. This position is a hybrid role with 2 days a week on-site in our San Diego, Ca. office.

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
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

Responsible for preparing clinical and regulatory documents to support Xencor’s clinical development and regulatory submission activities, including INDs, CTAs, BLAs, NDAs, and MAAs.
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.