The Medical Writing (MW) Operations team at Moderna is looking for an agile, self-motivated individual to serve as a Document Specialist. This individual will be responsible for supporting the MW Operations team with the preparation of clinical and regulatory submission‑related documentation for electronic submissions and archiving. The successful candidate will be detailed oriented, self-directed, and with the ability to be flexible and manage workload to meet project timelines.
Here’s What You’ll Do:
- Perform technical formatting review and editing of clinical and regulatory documents for submission to regulatory agencies in accordance with company-specific SOPs, templates, and style guide, within established timelines.
- Ensure that format and content of clinical and regulatory documents comply with applicable submission formatting regulations.
- Assist in the remediation of PDF documents by bookmarking, hyperlinking, and reviewing to ensure compliant regulatory files.
- Assist in the review and development of document templates, as needed.
- Identify and appropriately communicate risks associated with document formatting and propose mitigation plans.
- Support the MW Operations team Lead in scheduling and tracking of document formatting tasks, as needed.
- Attend project-related meetings, as assigned.
- Complete project-specific and company training, as assigned.
Here’s What You’ll Bring to the Table:
- Bachelor’s degree required. Life science or related allied health field preferred.
- Minimum of 3 years of document formatting experience in the biopharmaceutical industry.
- Working knowledge of GCP, FDA regulations, ICH guidelines (in particular ICH E3, E6, and E9)., and the drug development process.
- Familiarity with clinical study and submission documents such as protocols, Investigator Brochures, and CSRs.
- Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
- Project/time management and organizational skills, as well as the ability to work independently.
- Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
- Comprehensive Microsoft Office, especially Word but also Project, PowerPoint, and Excel skills.
- Ability to communicate with professionals from a variety of backgrounds.
- Attention to detail—style, consistency, grammar, syntax, scientific accuracy.