Regulatory Writing Senior Manager
hace 1 mes
Senior Regulatory Writing Manager
We are seeking an experienced Regulatory Writing Senior Manager to join our team at Syneos Health.
In this role, you will be responsible for managing medical writing activities and ensuring compliance with regulatory requirements.
This is an exciting opportunity to work with a dynamic team and contribute to the development of high-quality regulatory documents.
About You
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Strong understanding of FDA and ICH regulations and guidelines.
- Proven management skills with ability to lead a team of medical writers.
What We Offer
- An estimated salary range of $110,000 - $140,000 per year.
- A comprehensive benefits package including health insurance, retirement savings plan, and paid time off.
- Ongoing professional development opportunities to help you grow in your career.
Key Responsibilities
- Manage medical writing activities and ensure compliance with regulatory requirements.
- Develop and review regulatory documents, including IND submissions and annual reports.
- Collaborate with internal and external stakeholders to deliver high-quality results.
- Maintain up-to-date knowledge of regulatory requirements and industry trends.
About Syneos Health
Syneos Health is a leading biopharmaceutical solutions organization with a global presence. We accelerate customer success by translating insights into outcomes.
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