Sponsor Dedicated Sr Principal Medical Writer
We are seeking a highly experienced and skilled Senior Principal Medical Writer to lead our medical writing activities for regulatory document submissions globally.
Job Responsibilities:
* Develop clinical documents for submissions to regulatory authorities globally, adhering to ICH and other global guidelines, standards, and processes.
* Oversee medical writing activities for multiple compounds and serve as lead writer for individual summary documents.
* Mentor and lead less experienced medical writers on complex projects, as necessary.
* Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards, and processes, internal authoring standards, as applicable.
Qualifications:
* Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree.
* Solid Principal Medical Writer with experience gained from a CRO or Pharma.
* Excellent project management skills, including an in-depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
About Syneos Health:
We are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.