Job Summary:

Oversees clinical research, regulatory compliance, and research document management including the establishment of appropriate policies and standard operating procedures. Oversees internal and external quality assurance/audits of clinical trials and supporting functions. Manages National Institutes of Health (NIH) research financial conflicts of interest process and catalogue of the organization’s human subject research projects. Selects, develops, evaluates, and manages staff of Regulatory Affairs/ Quality Assurance/Records Management division.

Accountabilities:

• Directs and develops programs and processes to meet management objectives and compliance with government agencies.
• Oversees coordination and preparation of regulatory submissions to government agencies.
• Serves as the liaison to the Food & Drug Administration (FDA) and other regulatory agencies on matters related to one or more studies.
• Develops and manages budget for organizational unit and reports status to management.
• Advises/coaches staff to ensure compliance with internal and external policies, laws, and regulations.
• Participates in the strategic development of methods, techniques, studies, and people.
• Contributes to computer system validation efforts for all electronic clinical research systems.
• Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
• Performs other duties assigned.

Applied Knowledge & Skills:

• Comprehensive knowledge of theories, concepts and practices with regulatory agencies and compliance management.
• Excellent and demonstrated project management skills.
• Excellent oral and written communication skills.
• Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of studies/project goals.
• Ability to motivate, influence, and collaborate with others.
• Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
• Demonstrated commitment to diversity, equity, and inclusion.
• Must be able to read, write and speak fluent English.

Problem Solving & Impact:

• Decisions and actions have a significant impact on management and division operations.
• Problems encountered are complex, highly varied and require considerable judgment.
• Excellent strategic and operational decision maker that interprets business strategies and develops objectives to align with organization goals.

Supervision Given/Received:

• Sets goals and budgets for department and leads studies or projects that have significant financial implications.
• Leads coordination of resources for ongoing projects across business groups and addresses/resolves issues.
• Typically reports to the EVP & General Counsel.

Education:

• Bachelor’s Degree or its International Equivalent • Life Sciences, Communications, Journalism, Public Health or Related Field.

Experience:

• Typically requires a minimum of 10+ years of regulatory affairs and compliance management experience (including a minimum 5+ years of experience in a senior management/leadership position).
• Prior experience with managing a staff and interacting with the FDA and international regulatory agencies.

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time.
• Ability to lift/move up to 5 lbs.

Technology to be Used:

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• 10% – 25%

The expected US Based hiring salary range for this role is listed below. Candidate FHI 360 pay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI 360 factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, internal equity, business sector, and budget.

Base salary is only one component of our offer. FHI 360 contributes 12% of monthly base pay to a money purchase pension plan account. Additionally, all US based staff working full-time, which is calculated at 40 hours/week, receive 18 days of paid vacation per year, 12 sick days per year, and 11 holidays per year. Paid time off is reduced pro rata for employees working less than a full-time schedule.

US Based Hiring Salary Range: $130,000 – $180,000

International hiring ranges will differ based on location.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email [email protected].

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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Level of Education: Bachelor Degree

Work Hours: 8

Experience in Months: No requirements