Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
For our client, a global pharmaceutical organization we are currently looking for a Submission Specialist. In this role you will be working from the client’s office in Braine L’Alleud.
The responsibilities will be as follows:
- Planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and BMS processes.
- Creation and collection of the submission documentation and compilation of the core dossier for an application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start, conduct and close a BMS sponsored Interventional Phase I – Phase IV clinical study in any of the countries BMS or collaborative partners targets to conduct the study in, except the US.
- Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries.
- Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
- Liaise with local and central teams and CRO, as required, to ensure that study start-up activities are in compliance with study timelines and local regulations.
- Optimally compile and distribute the final Clinical Trial Application dossier (CTAp) and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities.
- Communicate information and escalates issues, liaise with country offices and CSO, Operation Leads, Protocol Managers, Medical Monitor, QP and CROs (for outsourced studies) to ensure that study start up activities are in compliance with study timelines, BMS SOPs, local regulatory guidelines and regulations.
- Comply with the use and maintenance of the available planning & tracking tools (e.g. IRIS - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates.
- Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.
The ideal candidate has:
- Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry.
- Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others.
- Experience in effective implementation of clinical plans/documents and document preparation.
- Previous experience working in an international team environment within a matrix organization.
- Experience in planning and coordination of study initiation.
- Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing ,a Master's degree is preferable, and 2-4 years of clinically related or relevant experience.
- Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol/site management.
- Knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met.
- Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.
- A detailed understanding of project planning and management methods.
- Thorough understanding of the drug development process and the impact of the European Clinical Trial Directive on BMS policies and procedures.
- Proficient use of ECLIPSE and related systems i.e. entry and study management functionalities.
- Capability to define process flows and procedures, to modify and improve them when and where necessary
How to apply?
Are you ready to join a game-changing company? In this role you’ll be fully employed by Syneos Health and will enjoy our very competitive primary and secondary benefits. Please contact Eveline Wigtman or Irene Houtsma.