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Senior Medical Writer
2 months ago
We are seeking a highly skilled Sr Medical Writer to join our team at Syneos Health. As a key member of our medical writing team, you will be responsible for creating high-quality medical content that meets the needs of our clients and regulatory requirements.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, ensuring the delivery of high-quality content.
- Act as lead for assigned writing projects, overseeing the development of clinical study protocols, reports, and other medical documents.
- Manage medical writing activities associated with individual studies, coordinating with cross-functional teams to ensure timely delivery.
- Develop and support a variety of documents, including clinical study protocols, reports, patient narratives, and regulatory submissions.
- Identify and propose solutions to resolve issues and questions arising during the writing process, ensuring compliance with regulatory standards.
- 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.
- Maintain familiarity with current industry practices and regulatory requirements, ensuring compliance with changing regulations.
- Work within budgeted hours and communicate changes to medical writing leadership, ensuring timely delivery of projects.
- 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, ensuring 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 not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- 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.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
