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 . We have an excellent opportunity for a Principal Medial Writer to join our position is a hybrid role with 2 days a week on-site in our San Diego Ca. officeSummary: Responsible for preparing clinical and regulatory documents to support Xencors 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 document review and approval to ensure timely document management systems related tools (including artificial intelligence) templates and procedures effectively to support efficient authoring review and finalization of documents and with and oversees contributions from contractors and edits and performs data verification and consistency checks for clinical regulatory manages reviews and edits publications including manuscripts abstracts and poster and coaches less experienced medical in departmental and cross-functional ideas and serves as a resource for improving departmental expertise and guidance on document design and best practices in medical to all departmental and company policies related to conduct performance and other duties as requires a bachelors 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 also requires:Ability to interpret and clearly present scientific and clinical trial dataKnowledge of statistical analysesExcellent technical writing skillsKnowledge of the drug development process and applicable regulatory guidelinesExperience working with regulatory agencies and collaborating with senior-level authors and contributorsStrong project management skillsExperience with SharePoint Smartsheet and Veeva preferredStrong interpersonal and communication skillsProficiency in Microsoft Word PowerPoint and ExcelAbility to manage multiple priorities in a dynamic environmentAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelOccasional 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: $169500 - $201500The 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.