.Description Principal Medical Writer 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. 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. Job Responsibilities The Principal Medical Writer will be responsible for the development of clinical documents for submissions to regulatory authorities globally. Works directly with multidisciplinary project team members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents. Role will be for the IAI Medical Writing Team, occasionally will assist the Oncology Medical Writing Team. Looking for someone at principal level, comfortable with submissions and ideally could lead the submission process. Will be involved with writing strategic parts of submission and will lead that process for other team members. Location: Europe or US Qualifications What we're looking for 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 with a familiarity with AMA style guide. Understanding of FDA and ICH regulations and guidelines strongly preferred. Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach
