Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including five programs currently in clinical testing with three more expected to start clinical testing by 1H2019 and have an excellent opportunity for Medical Editor to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with twelve in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We seek a Medical Editor to prepare scientific and regulatory documents to support Xencor’s clinical development and drug registration regulatory activities (INDs, IMPDs, NDAs, MAAs). The Medical Editor position is office-based.
Job duties are as follows:
• Independently or with minimal supervision perform data verification, edit, write, prepare, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports, investigator's brochures, and safety reports.
• Perform copyediting for grammar, punctuation, style, cross referencing and internal consistency.
• Collaborate effectively with other functional areas contributing to such documents to achieve submission schedules as prioritized by senior management.
• Administer QC checks to ensure documents comply with FDA guidelines.
• Help develop and manage SOPs and templates
• Keep abreast of professional information and technology through literature, symposia, and conferences.
• Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes. Provide expertise and guidance on document design and principles of good medical writing to department and product teams. Edit and coordinate review of CSRs, CSR appendices, and safety narratives.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• Bachelor's degree preferably in a physical science, life science, or health-related field (biology, chemistry, nursing, etc). Advanced degree (Masters, Doctorate) is a plus but not required.
• Three to 5 years of directly related experience in a pharmaceutical company or CRO environment supporting regulatory submissions to health authorities, US and/or EU. Candidates with greater level of experience will be considered.
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE