What are the responsibilities and job description for the Principal/Senior Manager, Medical Writing (Contract) Job at Thor Companies in Ca position at Thor Companies?
Principal / Senior Manager, Medical Writing (Contract)
We are working with an Oncology-focused Pharmaceutical company seeking a highly motivated, well-organized, and skilled Principal or Senior Manager of Medical Writing to develop clinical and regulatory documents in collaboration with internal and external stakeholders, and apply critical thinking, principles of scientific writing, data interpretation, and knowledge of regulatory content life cycle.
Client's preference is California / Pacific Time Zone
Strong Oncology Background Required
This is a 6-month contractor position.
What you'll do :
- Lead the preparation of clinical and regulatory documents (e.g., protocols, investigator brochures [IBs], safety updates, clinical study reports, IND / NDA / MAA CTD submission documents, briefing documents, and responses to regulatory authority questions) in accordance with applicable global and regional regulatory guidelines and Company partners’ standards / SOPs.
- Plan content in partnership with functional leads and create timelines for the development of assigned documents.
- Responsible for organization, clarity, scientific standards, formatting, and consistency of content within and across all documents for a program or within a clinical dossier.
- Lead document adjudication meetings and resolve issues with cross-functional contributors.
- Manage the review and approval process, including liaising with development partners.
- Work independently and effectively with cross-functional, geographically and culturally diverse teams, and establish strong collaborative relationships by creating an atmosphere of openness and trust.
Requirements :
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Science and Writing / Editing
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