Senior Medical Writer Specialist
1 week ago
Syneos Health is a leading biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are seeking an experienced Senior Medical Writer to develop clinical documents for submissions to regulatory authorities globally. The ideal candidate will have a solid understanding of global regulatory requirements and experience in developing high-quality clinical documents.
Key Responsibilities:
- Develop clinical documents for submissions to regulatory authorities globally.
- Oversee medical writing activities and serve as lead writer for individual summary documents.
- Mentor and lead less experienced medical writers on complex projects, as necessary.
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree.
- Excellent project management skills including in-depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
About Syneos Health
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. We take into consideration transferable skills from previous roles. Join our Talent Network to stay connected to additional career opportunities.
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