Medical Writer

Role Summary

The 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 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

• 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 document review meetings and discussions.
• 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.
• Participate in project team meetings.
• Performs other duties as assigned.

Qualifications

• A bachelor‚Äôs degree in science-related fields with 1+ years of experience is required; Or a master‚Äôs degree in science-related fields with some experience is required.
• 1+ year of medical writing experience preferred.
• Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions required.
• Strong scientific background in oncology, immunotherapy, or related field required.

Knowledge, Skills, & Abilities

• Proficient knowledge of AMA writing guidelines.
• Excellent verbal and written communication skills in English.
• Knowledge of FDA, EMA, and ICH guidelines.
• Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
• 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

• A bachelor‚Äôs degree in science-related fields with 1+ years of experience is required; Or a master‚Äôs degree in science-related fields with some experience is required.

Additional Requirements

• This position works onsite.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval
• Lift and carry materials weighing up to 20 pounds.