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Principal Medical Writer
My client 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.
They are looking for a Principal Regulatory Writer, with extensive experience in biotechnology, of at least 5 years, covering multiple therapeutic areas.
Job Responsibilities
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
- Develops or supports a variety of documents that include but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
- Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Requirements and qualifications:
- Bachelor of Science degree with relevant writing experience.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Fluency with principles of clinical research and to interpret and present clinical data and other complex information.
