Senior Medical Writer

Role 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.

Responsibilities

• 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.

Qualifications

• A bachelor‚Äôs degree in science-related fields with 4+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or a master‚Äôs degree in science-related fields with 2+ years of relevant industry experience in medical writing in the healthcare industry or academia required.
• Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required.
• Strong scientific background in oncology, immunotherapy, or related field is required.

Knowledge, Skills, & Abilities

• Proficient knowledge of AMA writing guidelines.
• Excellent verbal and written communication skills in English.
• Extensive knowledge of FDA, EMA, and ICH guidelines.
• Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
• Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Ability to work collaboratively in a dynamic environment.
• Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates.

Education

• Details provided in Qualifications: bachelor‚Äôs required with 4+ years, or master‚Äôs with 2+ years.

Additional Requirements

• The position works onsite in El Segundo, CA; Torrey Pines, CA; or remotely depending on geographic location. Lift and carry materials weighing up to 20 pounds. Regular work schedule Monday ‚Äì Friday with possible flexibility.