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Description Regional Submission Manager - Sponsor-dedicated (CTIS experience) 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. 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 Job responsibilities: Collaborates with major functional areas, including SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes. Drives regional submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverable associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required. Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines. Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct. Responsible for the co-ordination of translations for core documents required for submission. Manages the compilation for core package build, contributing to CTA and authoring documentation as required. CTA Manager may actas local country liaison when required. Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. Discussed with relevant SMEs the interpretation of dossier requirements. Qualifications Bachelor’s Degree, Higher Degree Preferred. Independent CTIS experience in initial submission and substantial amendments Ability to work on multiple highly complex projects simultaneously. Strong knowledge of the drug development process, regulatory sciences, CTA and submission management and publishing. In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experience in process development and new technology implementation. Ability to operate seamlessly and influence direct and indirect reports, as well as across organization. Demonstrated understanding of regional and national regulator filling guidelines and dossier requirements. Demonstrated ability to lead and deliver through others in matrix model. Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances Excellent understanding of clinical trial process across Phases II-IV and ICH GCP Good understanding clinical protocols and associated study specifications. Excellent understanding of clinical trial start-up processes. Excellent communication, presentation, and interpersonal skills. Quality-driven in all managed activities. Strong negotiating skills. Demonstrate an ability to provide quality feedback and guidance to peers. 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. http://www.syneoshealth.com 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. Show more Show less
