Spécialiste Soumissions Règlementaires - Sponsor dédié - Home Based Canada 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 Rejoignez une entreprise qui change la donne et réinvente la façon dont les thérapies sont développées et commercialisées. Créés grâce à la fusion de deux sociétés leaders dans l'industrie, Syneos Health rassemble plus de 30 000 spécialistes cliniques et commerciaux qui créent une nouvelle façon, plus intelligente et plus rapide, de mettre les thérapies biopharmaceutiques entre les mains des patients qui en ont le plus besoin. Une carrière chez Syneos Health signifie que votre travail quotidien améliore la vie des patients dans le monde entier. Syneos Health France recherche un Spécialiste Soumissions Règlementaires H/F - Poste en télétravail au Canada Rejoignez un groupe international en plein développement qui vous permettra d’évoluer dans un environnement professionnel stimulant au sein d’une équipe agréable et dynamique. Vous travaillerez pour un Sponsor dédié Responsabilités Au sein de l’équipe Soumissions Etudes Cliniques, et en collaboration avec les Coordinateurs réglementaires et administration des essais cliniques, vous aurez pour mission de : - Constituer, soumettre, assurer le suivi des dossiers de demandes d’avis et d’autorisation d’essai clinique auprès des autorités compétentes en étant l'interlocuteur règlementaire - Participer aux réunions des équipes projet pour la coordination des activités Start Up - Assurer le contrôle qualité des documents qui sont soumis aux authorités éthiques : revue et validation des ICFs et tout document destiné aux patients des essais Profil Le candidat que nous recherchons devra avoir l’expérience et les compétences suivantes: - Vous justifiez d’une expérience en recherche clinique au sein d’un(e) CRO/laboratoire pharmaceutique - Vous avez une expérience dans la gestion des soumissions règlementaire au niveau des autorités éthiques - Vous avez une connaissance de la réglementation relative aux Etudes Cliniques et des systèmes correspondants - Excellent relationnel et une bonne organisation #LI-ZB1 Disclaimer: 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. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. 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.

• Collecting and importing all hours and earnings files from various systems and sources for weekly and bi-weekly payroll processing. • Processing gross to net calculations in the payroll software. • Auditing hours, gross and net payroll expenses to ensure they are in line with previous pay periods; investigate and explain if variances. • Adhere to all internal financial controls to ensure accuracy of payroll expenses for SOX compliance. • Responsible for the accurate application of earnings and deduction codes and appropriate pay rates to ensure accuracy of employee pay and tax reporting. • Effectively communicate with appropriate departments and field branches on payroll issues and questions; ensure timely resolution of all payroll issues. • Review weekly reports to ensure all pay rates are entered properly for new employees and all that all final payments for terminations are processed according to state laws. • Adherence to HIPAA laws and PHI rules and guidelines. • Must follow all federal, state and local wage and hour laws and guidelines. • Maintains confidentiality of all payroll information.

• Develop and test the PeopleSoft Global Payroll rules engine • Update/modify existing extensions or tailored software • Design, develop, and maintain customizations and enhancements across a variety of PeopleSoft modules including HCM, Payroll, Benefits, Time & Labor, Financials (AP, AR, GL), and Campus Solutions. • Develop and support complex components using PeopleTools, PeopleCode, Application Engine, Integration Broker, Component Interface, and Event Mapping. • Strong experience with SQL, SQR, PS/Query, BI Publisher, and web services. • Support integrations with third-party and legacy systems using REST/SOAP Web Services, file-based integrations, and middleware tools. • Collaborate with business analysts and functional teams to gather requirements and translate them into technical solutions. • Troubleshoot and resolve performance issues, data integrity problems, and system bugs across multiple modules. • Apply security best practices, manage user roles/permissions, and ensure compliance with data privacy standards (HIPAA, FISMA, etc.). • Support batch scheduling, job streams, and workflow automation using Application Engine, Process Scheduler, and PeopleSoft Workflows. • Participate in Agile development processes and contribute to sprint planning, backlog grooming, and retrospectives. • Maintain comprehensive technical documentation, change control artifacts, and deployment packages.

• Own the end‑to‑end payroll process with high accuracy and confidentiality. • Manage payroll using ERP / HRIS / payroll tools. • Prepare and file statutory compliances: EPF, EPS, NPS, TDS (24Q), and social security returns. • Manage Form 16 generation, leave encashment, gratuity calculations, and payroll audits. • Address employee taxation and payroll‑related queries. • Prepare and publish MIS and payroll reports. • Coordinate with internal stakeholders and external vendors as required.