What are the responsibilities and job description for the Medical Writer Job at Precision Life Sciences in Boston position at Precision Life Sciences?
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
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