Key skills
Communication
About this role
Role Overview
- Implements all activities related to the preparation of defined medical and regulatory documents.
- Supports documents for regulatory submissions to US and global health authorities.
- Collaborates with cross-functional team members to ensure accurate and timely completion of documents.
- Supports clinical trial transparency and disclosures, including clinical trials registration and results posting.
- Contributes to departmental development through editorial and review support for document templates and style standards.
- Ensures adherence to relevant SOPs and internal best practices.
Requirements
- Bachelor’s degree required within a scientific discipline.
- 4+ years of medical writing experience in Sponsor or CRO setting.
- AMWA certification preferred.
- Experience using medical writing systems and technologies including Veeva RIM.
- Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance.
- Highly organized and detail-oriented with a passion to deliver quality results quickly.
- Strong verbal and written communication skills with an ability to build relationships internally and externally.
- Highest levels of professionalism, confidence, personal values, and ethical standards.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.