Principal Clinical Trial Regulatory Affairs

🔥 2 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. • Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs. • Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments. • Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs. • Works with the project leadership to define the strategy to execute against milestones and key deliverables. Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team. • Assumes accountability on the CTRA operations on specific project activities which may include but not limited to. • Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables. • Prepares/assists and presents overall submission strategy and status at client meetings and communicates outcomes to project team. • Reviews clinical trial study core documents (such as labeling for regulatory compliance etc.) • Coordinates and/or performs regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier). Performs study level tracking of the submission packages. • Centralizes and performs a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as Requests for Information RFIs (Requests for Information) during the submission review). • When required, employs effective technical and regulatory writing skills to author regulatory documents for submission purposes upon Sponsor agreement. • Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects. • Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams. • Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects. Oversees collation, quality review, and submission of country-specific applications. • Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables. • Identifies gaps in the evidence base supporting submissions and contributes to the development of regulatory recommendations and decisions. • Reviews the project budget against project milestones and budget to ensure project profitability. • Uses professionally recognized tools for planning and management of scope and ensures effective budget management. If out-of-scope work is requested, notifies the Site Activation Management, and tracks out-of-scope work until it is assigned to backlog. • Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues. • Explains complex technical regulatory issues into plain language to nontechnical audiences. • Accountable in parallel to lead regulatory activities for projects having high complex regulatory profiles as Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management). • Facilitates processes and communications within the CTRA Team. • May contribute to the development of new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in development activities including strategic account/ portfolio client meeting and/or reviews of proposals. • Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams. Actively participates in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. Designs and delivers basic training courses. • Uses communication skills to transfer knowledge to entry-level employees. Applies technical expertise in multi-disciplinary teams and explains the importance of adapting to the changing regulatory environment. • Ensures personal compliance and/or accuracy with relevant quality standards. Consistently achieves and maintains utilization target and departmental goals. • Maintains current knowledge of applicable regulations and guidelines. Identifies relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.

🎯 Requirements

• Bachelor’s Degree, Higher Degree Preferred. • Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non - interventional studies, clinical trial and medical device regulations) • Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc • Strong knowledge of clinical research management processes. Thorough knowledge of applicable 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 (both written and spoken) with an ability to influence, convince and persuade as well as a team-oriented approach. • Quality-driven in all managed activities • Strong negotiating and problem-solving skills. • Demonstrate an ability to provide quality feedback and guidance to peers.

🏖️ Benefits

• 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 building an inclusive culture – where you can authentically be yourself.