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Assoc Dir, Ssu Regulatory

3+ years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Associate Director, Site Start-Up & Regulatory

Updated:

April 21, 2025

Location:

North America - United States

Job ID:

25003188

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate clinical, medical affairs, and commercial insights into actionable outcomes to meet evolving market needs.
Our Clinical Development model places the customer and the patient at the center of everything we do, focusing on streamlining and simplifying processes to ensure an exceptional partnership and working experience.
With 29,000 employees across 110 countries, Syneos Health offers an opportunity where Work Here Matters Everywhere.

Why Join Syneos Health:

  • Strong focus on career development and progression.

  • Supportive, engaged line management and therapeutic area training.

  • Peer recognition and total rewards program.

  • Total Self culture — promoting authenticity and belonging.

  • Diverse, inclusive, and globally unified environment.

Job Responsibilities:

  • Oversee people management activities, including interviewing, hiring, development, performance appraisals, and counseling.

  • Mentor and coach managers and team leads in administrative and departmental activities.

  • Act as liaison between customer leaders and senior management, facilitating resource planning and communication.

  • Manage effective operations and SSU project deliverables across assigned programs/projects globally.

  • Develop and maintain strategic relationships with customers, collaborating with business development, contracts, clinical operations, and executive management.

  • Ensure that project targets are met, clients are satisfied, and services adhere to quality standards and policies.

  • Support management with site start-up activities, financial management tasks, and strategic process improvements.

  • Facilitate project reviews focusing on budget, schedule, risk analysis, and reporting department metrics.

  • Guarantee SSU delivery of assigned projects and/or initiatives.

  • Review and present project or departmental information, leading training programs for assigned teams.

  • Interact with Legal Departments for contract management workflows and risk identification.

  • Implement customer-required or enterprise-wide project management systems, acting as systems manager or supervising administrators.

  • Lead the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs).

  • Develop and implement strategies for tracking metrics and improving cycle times.

  • Ensure quality control efforts across departmental teams.

  • Represent the company at professional meetings or seminars.

  • Maintain training materials for assigned areas.

  • Contribute to and may lead change initiatives across SSU and Regulatory departments.

Qualifications:

  • Bachelor’s degree required.

  • Experience managing clinical research teams.

  • Strong leadership skills with ability to mentor and coach team members.

  • Ability to address and manage underperformance.

  • Extensive clinical trial experience required; sales experience preferred.

  • Strong knowledge of clinical research management processes and applicable regulations.

  • Understanding of regional needs across geographic areas.

  • Proven CRO operational experience with global project management expertise.

  • Excellent presentation, documentation, and interpersonal skills.

  • Proficient in MS Office (Word, Excel, PowerPoint), MS Project, and Internet tools.

  • Ability to manage multiple tasks and meet deadlines in a dynamic environment.

Salary Range:

  • Annual base salary: $97,000 to $170,000.

  • Actual salary will vary based on qualifications, skills, competencies, and proficiency.

About Syneos Health Achievements:

  • Supported 94% of all Novel FDA-Approved Drugs and 95% of EMA Authorized Products over the last 5 years.

  • Worked across 73,000 sites and with over 675,000+ trial patients globally.

Additional Information:

  • Tasks and responsibilities listed are not exhaustive and may change at the Company's discretion.

  • Equivalent experience, skills, and/or education will be considered.

  • Compliance with the Americans with Disabilities Act and the EU Equality Directive is ensured.