Senior Medical Writer

Position Summary

The Senior Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. The Senior Medical Writer will also be responsible for more complex writing assignments and will serve as subject matter expert within the department. The Senior Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational / training materials.

Essential Functions

• Serve as medical writing lead on more complex writing assignments. Work closely with in-function and cross-functional team(s) on document strategies. Implement all activities related to the preparation of writing projects.
• Serve as a subject matter expert within department for assigned therapeutic / product areas.
• Mentor less experienced medical writers on complex projects, as necessary.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
• Write, edit, and finalize clinical and non-clinical publications, congress materials, educational / training materials, and other external-facing documents.
• Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
• Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents.
• Lead project team meetings and document review meetings.
• Provide direction and solutions to cross-functional teams on expectations for document content.
• Perform QC of clinical and nonclinical documents.
• Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
• Perform other duties as assigned.

Education & Experience

Knowledge, Skills, & Abilities

Working Environment / Physical Environment

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

National Market

108,000 (entry-level qualifications) to $120,000 (highly experienced) annually

Premium Market

117,000 (entry-level qualifications) to $130,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include : Medical, Dental and Vision Plan Options