Medical Writer I /Medical Writer II (CSR Narratives)

Medical Writer I /Medical Writer II (CSR Narratives) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   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 deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Description •    Mentors less experienced medical writers on projects, as necessary. •    Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.  •    Develops or supports a variety of documents that include but not limited to:       o    Clinical study protocols and clinical study protocol amendments;      o    Clinical study reports;      o    Patient narratives;      o    Annual reports;      o    Investigator brochures. •    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. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. •    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.  •    Working knowledge of drug development process and regulatory guidelines. •    Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. •    Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. •    Completes required administrated tasks within the specified timeframes. •    Performs other work-related duties as assigned.  •    Minimal travel may be required (less than 25%).  Qualification required Should have Min 1 years of experience working in narratives with masters qualification and 2 years