Lead Medical Writer and Regulatory Expert
4 weeks ago
Job Description
Warman O'Brien seeks an experienced Lead Medical Writer and Regulatory Expert to join our team. This challenging role involves providing senior-level support for our medical writing team, including direct line management responsibilities.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with industry standards.
- Collaborate with cross-functional teams to develop high-quality regulatory documents.
- Conduct thorough reviews of clinical trial protocols and reports, ensuring accuracy and regulatory appropriateness.
- Maintain strong relationships with sponsors, addressing their regulatory needs and expectations.
Required Skills and Qualifications
- Degree in a life science or related field, with a strong background in medical writing and regulatory affairs.
- Minimum 5 years of experience in pharmaceutical regulatory documentation, with a proven track record of success.
Benefits
We offer a comprehensive benefits package, including health insurance, pension plan, and generous paid time off.
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