Principal clinical trial regulatory affairs
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 simplifying and streamlining our work to make syneos health easier to work with, and 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.
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 for. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.
job responsibilities
* collaborates as regulatory subject matter expert with major functional area leads to identify and evaluate fundamental issues pertaining to the site activation pathway.
* participates in strategic development activities including account/portfolio client meetings.
* line management responsibilities for staff members, including interviewing, selection, performance management, coaching, and employee counseling.
* develops and maintains strategic relationships with customers, proactively assessing client needs.
* ensures all project deliverables meet internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
* work with project leadership to define strategy to execute against milestones and key deliverables; prepares and presents overall regulatory strategy and status at client meetings.
* assumes accountability on the ctra operations on specific project activities, updating plans in accordance with sops and sponsor-scoped processes, compiling all controlled document requirements.
* prepares and assists in presenting overall submission strategy and status at client meetings.
* reviews clinical trial study core documents for regulatory compliance.
* coordinates and performs regulatory core submissions, including eu clinical trial regulation part i dossiers, and tracks submission packages.
* centralizes and performs critical analysis of cta competent authorities/ethics committees regulatory considerations, including rfis during the submission review.
* employs effective technical and regulatory writing skills to author regulatory documents for submissions upon sponsor agreement.
* prepares core clinical trial application dossiers for amendments/modifications during life cycle maintenance of projects.
* performs regulatory impact assessment on core amendment submission documents and communicates risk mitigation to sponsor/project teams.
* oversees collated, quality reviewed, and submitted country-specific applications.
* identifies gaps in the evidence base supporting submissions and contributes to regulatory recommendations and decisions.
* reviews project budget against milestones and ensures project profitability.
* facilitates processes and communications within the ctra team; acts as liaison between customer leaders and senior management regarding regulatory tasks.
* explains complex technical regulatory issues into plain language for non‑technical audiences.
* supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings; develops and implements training programs.
qualifications
* bachelor’s degree; higher degree preferred.
* subject matter expertise in current regulation frameworks (e.g., regulations and guidelines specific for noninterventional studies, clinical trial, and medical device regulations).
* experience working to applicable gxps (e.g., gvp, gcp, iso 14155).
* strong knowledge of clinical research management processes, regulations, drug development, and clinical project management procedures.
* previous experience in budgeting and quality management.
* ability to teach/mentor team members.
* ability to coach employees to reach performance objectives.
* ability to recognize and take appropriate action when employee performance is not acceptable.
* excellent communication and interpersonal skills with the ability to influence, convince, and persuade.
* quality-driven in all managed activities.
* strong negotiating and problem‑solving skills.
* demonstrates an ability to provide quality feedback and guidance to peers.
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 will determine what constitutes equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. All language complies with the legislation of each country in which the company operates, including compliance with the eu equality directive and the americans with disabilities act, with reasonable accommodations provided as appropriate.
seniority level
mid‑senior level
employment type
full‑time
job function
education and training
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