Associate Director, Medical & Regulatory Writing

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 . We have an excellent opportunity for an Associate Director Medical & Regulatory Writing to join our position will be based from our San Diego office and hybrid twice a : 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 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 Investigators Brochures Clinical Study Reports Regulatory briefing documents Module 2 summary documents and other clinical and regulatory 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 neededNegotiates with functional areas regarding deliverables and timelines to meet conflicting demands removing barriers and using creativity to ensure teams achieve document-related project goalsCommunicates deliverables needed writing process and timelines to team members and manages agreed-upon document timelines and milestonesEnsures compliance with relevant regulatory guidelines industry best practices and ethical standards in medical writing and communicationMaintains document templates style guides and best practices to ensure consistency and quality in written materialsOversees the planning coordination and execution of medical writing by external vendors and consultants to ensure milestones are met and resources are allocated efficientlyProvides guidance to less experienced medical writers and external to all department and company-wide policies regarding conduct performance and proceduresProvides oversight and direction to direct and indirect reports as applicable in accordance with the organizations 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 opportunitiesPerforms other duties as minimallyrequires a Bachelors 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 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 guidelinesStrong collaboration skills and the ability to foster strong working relationships and build consensus within multidisciplinary teamsExceptional project management skills and the ability to manage a variety of projects simultaneously in a matrixed and dynamic environmentExcellent interpersonal and communication skillsExpertise 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 driveAbility to effectively manage others through coaching and supervision in accordance with company policies and practices and ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal accomplishmentFamiliarity 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 Xencors Leadership Competency travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $ 175500 - $205000The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe 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 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 Employment Opportunity (EEO) StatementThe 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 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.