.Updated: September 24, 2024Location: Mexico-Latin America - MEX-Home-BasedJob ID: 24004553Syneos 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.Why Syneos HealthWe 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.Job ResponsibilitiesMentors 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 that include, but are not limited to:Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissionsand annual reports; Integrated summary reports; NDA and (e)CTD submissions; Investigator brochures; Clinical journal manuscripts, clinical journal abstracts, 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, and for 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.Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.Performs on-line clinical literature searches, as applicable