Summary:

Responsible for providing clinical and regulatory document authoring and advanced medical writing expertise to cross-functional teams while ensuring the successful and timely preparation of high-quality documents.

Job Duties:

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: clinical protocols, Investigator's Brochures, Clinical Study Reports, Regulatory briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Participates in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents
• Represents Medical and Regulatory Writing at various team meetings as needed
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Communicates deliverables needed, writing process, and timelines to team members, and manages agreed-upon document timelines and milestones
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials
• Oversees the planning, coordination, and execution of medical writing by external vendors and consultants to ensure milestones are met and resources are allocated efficiently
• Provides guidance to less experienced medical writers and external vendors.
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization's policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Performs other duties as required.

Education/Experience/Skills:

Position minimally requires a Bachelor's degree in a life science or writing discipline, a Masters or a PhD is preferred. Also requires a minimum of 10 years of medical/regulatory writing experience in the pharmaceutical, biotechnology, or related life sciences industry. Experience leading major regulatory documents or submission components and providing oversight of internal or external writing resources also required. Prior experience in a leadership role in major regulatory filings (INDs, CTAs, NDAs, BLAs) also required. Experience working in a small company environment is also preferred.

Position also requires:

• Strong understanding of interpreting and presenting scientific and clinical trial data
• Excellent technical writing skills
• Comprehensive knowledge of the drug development process and regulatory guidelines
• Strong collaboration skills and the ability to foster strong working relationships and build consensus within multidisciplinary teams
• Exceptional project management skills and the ability to manage a variety of projects simultaneously in a matrixed and dynamic environment
• Excellent interpersonal and communication skills
• Expertise in multiple computer-based tools such as SharePoint and Veeva RIM, in addition to programs such as Word, PowerPoint, Excel, etc.
• Commitment to the values of integrity, accountability, transparency, scientific rigor and drive
• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices, and ensures employee performance meets the organization's expectations for conduct productivity, quality, continuous improvement, and goal accomplishment
• Familiarity with AI tools and the ability to use them in a compliant and responsible manner, including validating outputs, mitigating risks, actively reinforcing responsible use across teams, and ensuring strict adherence to company policies and regulatory requirements
• 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: $ 175,500 - $205,000

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/.