Medical Writer

Job Title: Medical Writer

PRINCIPLE DUTIES:

• Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents 
• As needed, 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 

QUALIFICATIONS/EXPERIENCE:

• Minimum of Bachelor’s degree in science (Masters or Ph.D. preferred) 
• Experience in IND and/or NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissions 
• A minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred. 
• Strong scientific background in rheumatology, endocrinology, metabolic disease, or related field 

KEY COMPETENCIES:

• 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 particularly in preparing the NDA. 
• Excellent time- and project management skills, attention to detail, and ability to balance multiple projects simultaneously 
• Strong critical and logical thinking with the 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