Principal Medical Writer

Introduction:

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

Summary:

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

Primary 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.

Education/Experience/Skills:

Position requires a bachelor's degree in a physical science, life science, or health-related field such as biology, chemistry, or nursing and 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. An advanced degree is preferred, as is experience in a small-company environment.

Position also requires:

• 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
• Experience with SharePoint, Smartsheet, and Veeva preferred
• 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

Occasional travel may be required, including travel between Xencor's Pasadena and San Diego offices. Work for this position is generally performed at Xencor's worksite and requires full-time commitment.

Expected Base Salary Range: $169,500 - $201,500

The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.