Descripción de la oferta
Description Medical Writer - Future roles (Spain) 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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. Job Responsibilities Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with moderate supervision. Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; and investigator brochures. Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, company and/or client-approved templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Interacts and builds good working relationships with clients, department head, and peers, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve document issues, escalating as appropriate. Continues professional development to grow awareness of industry standards and best practices to improve ability to meet client expectations. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects. #J-18808-Ljbffr
