Principal Clinical Trial Regulatory Affairs - +4 years of experience with multiple countries regulatory submissions - Colombia Hybrid

Principal Clinical Trial Regulatory Affairs - +4 years of experience with multiple countries regulatory submissions - Colombia Hybrid

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Supports the customer-focused leadership and management of CTRA deliverables within the assigned projects or programs. Contributes to the technical and operational aspects of the CTRA deliverables of the assigned projects. Develops and maintains strategic relationships with customers.

Compiles core packages, completes project regulatory assessments, submission forms and uploads documents to CTIS (Clinical Trial Information System) as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), Site Activation Management and Project Sponsor.

Responsibilities:

• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
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• Participates in strategic development activities including account/ portfolio client meetings.
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• 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.
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• Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs.
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• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
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• Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
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• Work 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.
  • Review clinical trial study core documents (such as labelling for regulatory compliance etc.)
  • Coordinate and/or perform regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier). Perform study level tracking of the submission packages.
  • Centralize and perform 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, employ effective technical and regulatory writing skills to author regulatory documents for submissions purpose 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.
  • Identify gaps in the evidence base supporting submissions and contribute 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 back log.
  • Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.
  • Explain complex technical regulatory issues into plain language to nontechnical audiences.
• Accountable in parallel to lead regulatory activities for projects having high complex regulatory profile 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 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 participate 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.
  • Use communication skills to transfer knowledge to entry-level employees. Apply technical expertise in multi-disciplinary teams and explain the importance of adapting to the changing regulatory environment.
• Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals
• Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.

Qualifications:

• 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.

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.

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.