Medical Writer

Clinical Development · San Diego, California
Department Clinical Development
Employment Type Full Time
Minimum Experience Manager/Supervisor

Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Medical Writer to join our team.

 

Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen, and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.

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 an experienced medical writer (remote or in-house) to prepare scientific and regulatory documents to support Xencor’s clinical development and drug registration regulatory activities (INDs, IMPDs, NDAs, MAAs). 

Job duties include the following:

  • Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, investigator's brochures, data safety update reports, and clinical study reports.
  • Perform copyediting for grammar, punctuation, style, and internal consistency.
  • Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management.
  • Administer QC checks to ensure documents comply with FDA guidelines.
  • Help develop and manage medical writing processes, SOPs, and templates for key documents.
  • Help manage the functional review of study documents produced by contract writers.
  • 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.

 

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.

Qualifications/Requirements:

  • 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.
  • 8 + 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.

 

Desired Skills:

  • Experience with SharePoint and Veeva a plus.

 

Physical Demands

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

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  • Location
    San Diego, California
  • Department
    Clinical Development
  • Employment Type
    Full Time
  • Minimum Experience
    Manager/Supervisor