The Senior Medical Writer will be responsible for preparing high-quality regulatory documents, including clinical study reports, clinical summaries, and study protocols. The position requires a strong scientific background in oncology, immunotherapy, or related field, with experience in NDA submissions and writing CSRs, IBs, and other documents for regulatory submissions.
Requirements
- Serve as medical writing lead on more complex writing assignments.
- Work closely with in-function and cross-functional team(s) on document strategies.
- Implement all activities related to the preparation of writing projects.
- Mentor less experienced medical writers on complex projects, as necessary.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
- Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
- Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents.
- Lead project team meetings and document review meetings.
- 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.
- Perform other duties as assigned.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO)
