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Medical Writer Lead
2 months ago
We are seeking a highly skilled Medical Writer to join our team at Syneos Health. As a Medical Writer, you will be responsible for creating high-quality clinical documents, including clinical study protocols, clinical study reports, and regulatory submissions.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects, ensuring timely delivery and high-quality output.
- Manage medical writing activities associated with individual studies, coordinating with departments and stakeholders as needed.
- Develop and support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and regulatory submissions.
- Identify and propose solutions to resolve issues and questions arising during the writing process.
- Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency.
- Interact with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables.
- Serve as a peer reviewer on internal review teams, providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines, and Company Standard Operating Procedures.
- 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 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 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.
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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.
