Medical Writer

New Moderna Job in MA

The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to serve as an integral part of the Medical Writing Team to support clinical project teams to meet their clinical document deliverables. The successful candidate will be detail oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.

Here's What You'll Do:

• Serve as the medical writing Lead contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and other regulatory submissions documents. Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents. Plan and coordinate timelines to ensure timely completion of clinical writing projects.
• Manage timelines and communicate with team stakeholders to maintain awareness of expectations, milestones, and deliverables.
• Lead significant work streams that involve work across departments or with external vendors.
• Provide support for QC of complex clinical documents.

Here's What You'll Bring to the Table:

• Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred.
• Minimum of six years medical writing experience with a total years of pharmaceutical or biotech experience required.
• Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
• Experience producing high quality clinical and regulatory submission documents.
• Strong project management and organizational skills.
• Strong organizational/prioritization skills for the management of multiple concurrent projects.
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches.
• Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes