Senior Medical Writer
hace 4 semanas
We are seeking a highly skilled Senior Medical Writer to join our team in a senior regulatory affairs specialist role. As a key member of our clinical development team, you will be responsible for mentoring and leading less experienced medical writers on complex projects.
The ideal candidate will have a strong background in medical writing, with experience in developing and supporting a variety of documents, including clinical study protocols, clinical study reports, and IND submissions.
You will work closely with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables.
This is a unique opportunity to work with a leading biopharmaceutical solutions organization, where you will have the chance to simplify and streamline our work, making Syneos Health easier to work with and for.
We are passionate about developing our people, through career development and progression, and we are committed to our Total Self culture, where you can authentically be yourself.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects
- Act as lead for assigned writing projects
- Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
- Develop or support a variety of documents, including clinical study protocols, clinical study reports, and IND submissions
- Identify and propose solutions to resolve issues and questions arising during the writing process
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
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