Sr. Medical Writer (Clinical Development & Regulatory)

Medical Writing · San Diego, California
Department Medical Writing
Employment Type Full Time
Minimum Experience Mid-level

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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Sr. Medical Writer to join our team. This role will be remote. 

 

Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.

 

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 currently have an excellent opportunity for a talented Sr. Medical Writer to join our team!  


Summary:

The Senior Medical Writer will prepare scientific and regulatory documents to support Xencor’s clinical development and drug registration regulatory activities (INDs, IMPDs, NDAs, MAAs).


Job Duties Include:

  • Lead collaboration with functional area authors/subject matter experts to develop and/or update documents in accordance with applicable regulatory guidelines.
  • Documents include, but are not limited to, the following: protocols and protocol amendments, investigator brochures, IND summary documents, IMPDs, NDA summary sections, regulatory responses, clinical study reports, and publications.
  • Manage the document review and approval process to ensure timely completion of documents.
  • Collaborate with and supervise contributions from contractors and vendors.
  • Write, edit, perform data verification, submit for review, and obtain approval for clinical regulatory documents.
  • Review and/or edit publications (manuscripts, abstracts, poster presentations, etc).
  • Work effectively with company document management systems and related tools, templates, and procedures to ensure efficient publishing of documents and dossiers.
  • Administer QC checks to ensure documents comply with FDA guidelines.
  • Perform copyediting for grammar, punctuation, style, and internal consistency.
  • 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.


Job Qualifications:

  • 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.
  • Must have at least 5 years direct experience leading teams in authoring/editing protocols, investigator brochures, clinical study reports, and other clinical regulatory documents.
  • Must have at least 8 years directly related experience in a pharmaceutical company or CRO environment supporting regulatory submissions to health authorities in the United States and/or European Union.8
  • Highly competent user of pertinent software (e.g., Word and PowerPoint)
  • Thorough understanding of FDA guidelines and regulations
  • Experience working with regulatory agencies and collaborating with senior-level authors and contributors
  • Exceptional project management skills.

Desired Skills:

  • Experience with SharePoint, SmartSheet, and Veeva a plus
  • PMP certification- or is there any other type of certification or training that would be beneficial but not required?

Physical, Mental and Environment Demands:

The physical, mental and working environment 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 associated 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.

 

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

  • Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
  • Ability to work and sustain attention with distractions and/or interruptions.
  • Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
  • Ability to maintain regular attendance and be punctual.
  • Ability to understand, remember and follow verbal and written instructions.

Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.


Physical, Mental and Environment Demands:

The physical, mental and working environment 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 associated 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.

 

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

  • Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
  • Ability to work and sustain attention with distractions and/or interruptions.
  • Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
  • Ability to maintain regular attendance and be punctual.
  • Ability to understand, remember and follow verbal and written instructions.

Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

 

Americans with Disabilities Act (ADA) Statement

The 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 HR@xencor.com.

 

To 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 functions.

 

Equal Employment Opportunity (EEO) Statement

The 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 law.

 

Xencor 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.




 


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  • Location
    San Diego, California
  • Department
    Medical Writing
  • Employment Type
    Full Time
  • Minimum Experience
    Mid-level