Associate Director, Medical & Regulatory Writing

RiseMe; San Diego (CA); Hybrid; USD 176,000 - 205,000; Full time

Benefits offered by this job

401k match

Healthcare coverage

Annual bonus

Job summary

Xencor seeks an Associate Director of Medical & Regulatory Writing to lead advanced medical writing for cross-functional teams in a hybrid San Diego role. You will ensure timely, high-quality submission documents and manage external vendors.

Required: 10+ years in Pharma/biotech medical writing with IND/ NDA experience; leadership in major regulatory filings; strong collaboration and project management skills.

Qualifications

• Bachelor's degree in a life science or writing discipline; Masters/PhD preferred.
• Minimum of 10 years medical/regulatory writing in pharma/biotech.
• Experience leading major regulatory documents or submission components.

Responsibilities

• Collaborate with cross-functional teams to prepare, review, and edit submission-ready documents (protocols, Investigator’s Brochures, Clinical Study Reports, regulatory briefing docs).
• Develop and maintain document templates, style guides, and SOPs for consistency and quality.
• Represent Medical and Regulatory Writing in team meetings and coordinate with external vendors.
• Negotiate timelines with functions to meet deliverables and milestones.
• Ensure compliance with regulatory guidelines and ethical standards in medical writing.

Skills

Medical Writing

Regulatory Writing

Leadership

Project Mgmt

Veeva RIM

SharePoint

Education

Bachelor's in life science or writing

Masters or PhD preferred

Tools

Word

PowerPoint

Excel

Job description

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 www.xencor.com. We have an excellent opportunity for an Associate Director, Medical & Regulatory Writing, to join our team.

This position will be based from our San Diego office and hybrid twice a week.

Summary:

Responsible for providing clinical and regulatory document authoring and advanced medical writing expertise to cross-functional teams while ensuring the successful and timely preparation of high-quality documents.

Job Duties:

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: clinical protocols, Investigator’s Brochures, Clinical Study Reports, Regulatory briefing documents, Module 2 summary documents, and other clinical and regulatory documents.


• Participates in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents


• Represents Medical and Regulatory Writing at various team meetings as needed


• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals


• Communicates deliverables needed, writing process, and timelines to team members, and manages agreed-upon document timelines and milestones


• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication


• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials


• Oversees the planning, coordination, and execution of medical writing by external vendors and consultants to ensure milestones are met and resources are allocated efficiently


• Provides guidance to less experienced medical writers and external vendors.


• Adheres to all department and company-wide policies regarding conduct, performance and procedures


• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities


• Performs other duties as required.

Education/Experience/Skills:

Position minimallyrequires a Bachelor's degree in a life science or writing discipline, a Masters or a PhD is preferred. Also requires a minimum of 10 years of medical/regulatory writing experience in the pharmaceutical, biotechnology, or related life sciences industry. Experience leading major regulatory documents or submission components and providing oversight of internal or external writing resources also required. Prior experience in a leadership role in major regulatory filings (INDs, CTAs, NDAs, BLAs) also required. Experience working in a small company environment is also preferred.

Position also requires:

• Strong understanding of interpreting and presenting scientific and clinical trial data


• Excellent technical writing skills


• Comprehensive knowledge of the drug development process and regulatory guidelines


• Strong collaboration skills and the ability to foster strong working relationships and build consensus within multidisciplinary teams


• Exceptional project management skills and the ability to manage a variety of projects simultaneously in a matrixed and dynamic environment


• Excellent interpersonal and communication skills


• Expertise in multiple computer-based tools such as SharePoint and Veeva RIM, in addition to programs such as Word, PowerPoint, Excel, etc.


• Commitment to the values of integrity, accountability, transparency, scientific rigor and drive


• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices, and ensures employee performance meets the organization’s expectations for conduct productivity, quality, continuous improvement, and goal accomplishment


• Familiarity with AI tools and the ability to use them in a compliant and responsible manner, including validating outputs, mitigating risks, actively reinforcing responsible use across teams, and ensuring strict adherence to company policies and regulatory requirements


• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.

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

Expected Base Salary Range: $ 175,500 - $205,000

Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

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 [e-mail].

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.