Principal Medical Writer
1 giorno fa
We are seeking a highly skilled Principal Medical Writer to join our IAI Medical Writing Team at Syneos Health. As a key member of our team, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.
Key Responsibilities:- Develop scientifically valid, complete, and consistent clinical documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), and other regulatory documents.
- Work closely with multidisciplinary project team members to ensure seamless collaboration and effective communication.
- Lead the submission process and contribute to the development of strategic parts of the submission.
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Previous writing experience with clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), and other regulatory documents.
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 are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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