What are the responsibilities and job description for the Medical Writer 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
