Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based
Syneos Health3 days ago
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RemoteFull-timeMid
Summary
Syneos Health is seeking a Principal Medical Writer - Submission Docs to join their team in a remote capacity. The role involves developing regulatory documents for submission to global regulatory agencies, ensuring compliance with ICH and other guidelines.
About the Role
As a Principal Medical Writer, you will be responsible for developing clinical documents such as Clinical Study Reports and Clinical Summaries of Efficacy and Safety. You will manage medical writing projects, participate in cross-functional meetings, and ensure timely delivery of high-quality documents that meet regulatory requirements. You will also oversee the medical writing activities of multiple compounds and serve as the lead writer for individual summary documents.
About You
Required:
- Extensive experience in medical writing, particularly in regulatory submissions.
- Strong understanding of clinical research processes and global regulatory document standards.
Preferred:
- Experience with eCTD submissions.
- Ability to mentor less experienced writers.
Benefits
- Career development and progression opportunities.
- Supportive and engaged line management.
- Technical and therapeutic area training.
- Peer recognition and total rewards program.
Syneos Health
Syneos Health® is 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. We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
United States