Senior Clinical Writer Regulatory Affairs
7 days ago
About Us
Syneos Health, Inc. is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
Job ResponsibilitiesThe Principal/Sr Regulatory Medical Writer will be responsible for mentoring and leading less experienced medical writers on complex projects, acting as a lead for assigned writing projects, and managing medical writing activities associated with individual studies.
This role will involve developing or supporting a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and eCTD submissions, investigator brochures, clinical journal manuscripts, clinical journal abstracts, and client presentations.
The successful candidate will have extensive knowledge of English grammar and FDA and ICH regulations and guidelines, as well as a familiarity with AMA style guide. They will also have strong proficiency in Word, Excel, PowerPoint, email, and Internet, and be able to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Qualifications- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
At Syneos Health, Inc., we offer a total rewards package that reflects our commitment to developing our people and creating a workplace where everyone feels like they belong. This includes career development opportunities, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
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