Job Description

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 #J-18808-Ljbffr Precision Life Sciences

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