Senior Medical Writing Professional
hace 4 días
Senior Medical Writer Position Overview
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of our work. We strive to simplify and streamline our operations to make Syneos Health easier to work with and for.
We offer a unique opportunity to collaborate with passionate problem solvers in a Functional Service Provider partnership or Full-Service environment. As a team, we innovate to help our customers achieve their goals. Our agility enables us to accelerate therapy delivery because we're passionate about changing lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.
Why Syneos Health?
We are dedicated to developing our people through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program. Our Total Self culture unites us globally, and we're committed to taking care of our people. We continuously build 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.
Job Responsibilities:
- Mentors and leads less experienced medical writers on complex projects as necessary.
- Acts as lead for assigned writing projects.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develops or supports a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA submissions, investigator brochures, clinical journal manuscripts, and client presentations.
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serves as peer reviewer on internal review team providing review comments on draft and final documents.
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