CSR Appendices Coordinator

CSR Appendices Coordinator - Home Based at Syneos Health 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 centers the customer and the patient. We strive to simplify and streamline our work to make Syneos Health easier to work for and with. Job Responsibilities Defines scope of Clinical Study Reports (CSR) Appendices with the document author. Coordinates and track activities and perform detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS). Confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (RIMS). Maintain strong knowledge of CSR and CSR Appendices and CTD structure. Effectively communicates deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills. Effectively attends to multiple tasks within overlapping timeframes; builds positive and productive relationships that enable high quality documents to be completed on time. 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 Responsible for authoring of Clinical Study Report (CSR) Appendices and managing clinical and regulatory references. Seniority level Entry level Employment type Part-time Job function Other #J-18808-Ljbffr