Principal Medical Writer - Regulatory Submission Documents
$80.6k/y-$145k/y
Syneos Health2 months ago
Highlight
OnsiteFull-timeMid
Summary
Syneos Health is seeking a Principal Medical Writer - Regulatory Submission Documents to join their team in the United States. The role involves leading the completion of medical writing deliverables and managing writing activities for regulatory submissions.
About the Role
As a Principal Medical Writer, you will be responsible for ensuring the clear and accurate completion of various medical writing deliverables, including clinical study protocols, reports, and regulatory submissions. You will manage writing activities across departments, adhere to regulatory standards, coordinate quality reviews, and mentor less experienced writers. Your role will also involve building relationships with clients and conducting literature searches.
About You
Required:
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
- 3-5 years of relevant experience in science, technical, or medical writing.
- Experience working in the biopharmaceutical, device, or contract research organization industry.
- Strong understanding of FDA and ICH regulations and good publication practices.
- Experience writing relevant document types.
Preferred:
- Extensive knowledge of English grammar and familiarity with AMA Manual of Style.
- Strong presentation, proofreading, collaborative, and interpersonal skills.
- Strong project and time management skills.
- Strong proficiency in MS Office.
- Strong understanding of medical terminology and principles of clinical research.
Benefits
- Company car or car allowance.
- Health benefits including Medical, Dental, and Vision.
- Company match 401k.
- Eligibility to participate in Employee Stock Purchase Plan.
- Eligibility to earn commissions/bonus based on company and individual performance.
- Flexible paid time off (PTO) and sick time.
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