Regulatory Affairs Document Medical Editor

Regulatory Affairs – San Diego, California
Department Regulatory Affairs
Employment Type Full Time
Minimum Experience Experienced

Medical Writer

San Diego. CA

 

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 three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a 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 ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations  with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, Merck, 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 Writer to

 Job Duties include :

  • Perform proofreading, formatting, and copyediting for multiple compounds and/or projects as needed for clinical trial/regulatory documentation projects such as clinical study reports, protocols, investigator brochures, IND/CTA modules.
  • Create and/or review PowerPoint presentations summarizing protocols, CSRs, etc. as needed
  • Review documentation for internal consistency of information, consistency with source documents, and compliance with regulatory requirements and internal SOPs.
  • Correspond with authors and peer reviewers and drive the completion of document projects in a matrix fashion
  • Proofread at each stage of document development through final submission.
  • Converts data and information into a format that meets clinical regulatory document requirements.
  • Coordinate/supervise any external medical/regulatory writing projects as required
  •   
  • 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:

  •  BA/BS degree in English or a scientific discipline.
  • Minimum of 8 years of editorial/proofreading experience in medical communications and/or clinical trial documents; or minimum of 6 years medical or technical writing experience.
  • Experience editing/proofreading clinical trial and regulatory documentation such as clinical study reports, protocols, investigator’s brochures and IND/CTA modules.
  • Excellent organizational and multitasking skills
  • A strong attention to detail and accuracy is critical
  • Ability to work with minimal supervision and complete scheduled tasks on time.
  • Ability to prioritize multiple tasks, often under deadlines.
  • Understanding of AMA Manual of Style.
  • Extremely proficient with in MS Word, Excel, and PowerPoint.
  • Strong communication and interpersonal skills.
  • Ability to follow direction and motivated to learn organization procedures.
  • Practical knowledge and experience with eCTD content templates.
  • Familiar with Veeva Vault organization a plus.

 

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
    Regulatory Affairs
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced
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