Creative Regulatory Content Specialist
2 days ago
The organization is seeking a highly experienced Key Medical Content Writer to fill a key role in our content creation team. The ideal candidate will have 4-8 years of experience in writing clinical and regulatory documents, with a focus on supporting global filings.
Principal Responsibilities:- Writing and editing high-quality clinical document types that support regulatory filings, including Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports, protocols, amendments, ICFs & amendments, and Investigator Brochures.
- Leading cross-functional teams to draft scientific/medical content that addresses data interpretation, product claims, and internal/external questions.
- Developing work plans for individual and multiple-document delivery, with tasks, subtasks, timelines, and assigned roles and responsibilities.
The successful candidate will possess excellent communication skills, effective time management, and organizational and interpersonal skills. They will be comfortable following directions, templates, and structured processes, and will be able to work independently while maintaining communication with the project manager.
Requirements:- 4-8 years of experience in writing clinical and regulatory documents.
- Demonstrated excellence in focused/lean writing and editing.
- Strong knowledge of regulatory guidelines/requirements and regional guidelines.
- Ability to interpret data and apply scientific knowledge to support regulatory document writing.
Preferred Skills:
- Experience with clinical trial design.
- Comfortable working on cross-functional teams.
- Ability to build clinical or regulatory arguments using logic, analogy, and therapeutic area science.
Equal Opportunity Statement:
The organization is committed to diversity and inclusivity and welcomes applications from all qualified candidates.
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