Regional Regulatory Manager

We need to output HTML fragment HTML with sections: About Us? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. The posting includes "About Us", "About the Job", "ESSENTIAL JOB FUNCTIONS", "PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS", "Requirements", "Benefits". We need to map to appropriate headings. Likely sections: About Us (maybe not required but we can include as heading? The list includes "About the role" as example; but we can include "About Us" as a heading if content present. However they said use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They didn't forbid other headings, but they gave examples. Probably we should include headings that match content: About Us, About the Job (maybe "About the role"), Responsibilities (essential job functions), Requirements, Benefits. Also maybe "Physical Requirements" could be part of Requirements or separate? Could be a subsection but we can include under Requirements. They said prefer few substantive sections over many thin ones. So we can combine. We need to preserve all substantive information, no boilerplate. Remove EEO etc. Also remove duplicated lines. Remove cookie/navigation/legal/EEO etc. So we strip the EEO paragraph at end. We need to output only HTML fragment, no /. Use

for headings,

• for lists,

  for prose. We need to include all substantive info: About Us paragraph(s), About the Job (including purpose, remote, shift, location), Essential Job Functions (list many), Physical Requirements/Environmental Factors (list), Requirements (education, experience, knowledge and skills), Benefits (list). Also maybe mention "Shift: Monday-Friday (40 hours per week)" and "Location: Remote- United States". Also mention "This is a remote position." Also mention "Purpose: To oversee..." etc. We must not invent or summarize away detail. Must preserve all details. We need to avoid filler like "commensurate with experience" etc. Not present. We need to not include Pay/Schedule/Benefits unless posting actually states them. Benefits are stated, so include Benefits section. Pay not stated, so omit Pay section. Schedule: they gave shift Monday-Friday 40 hours per week, that's schedule info. Should we include a Schedule section? The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. They gave shift info, which is schedule. So we could include a Schedule section with that detail. However they said prefer few substantive sections over many thin ones. Could combine schedule into About the Job or Responsibilities. But schedule is a specific detail; we could include it in About the Job paragraph. Probably fine to keep in About the Job. We need to ensure we don't repeat job title as heading. The job title is Regional Regulatory Manager. Not to be used as heading. We need to drop minor metadata like Job ID/requisition numbers (none present). Also drop duplicated lines. Let's extract content. About Us: Paragraph(s) about Flourish Research. We'll keep as prose. About the Job: includes "We are actively hiring a Regional Regulatory Manager. This is a remote position. Shift: Monday-Friday (40 hours per week) Location: Remote- United States PURPOSE: ..." We'll keep as prose, maybe break into sentences. Essential Job Functions: a long list of duties. We'll make

  • each bullet. Physical Requirements and/or Environmental Factors: list items. Requirements: includes Education, Experience, Knowledge and Skills (which is a list of many items). We'll treat Knowledge and Skills as a list. Benefits: list. We need to ensure we don't include the EEO statement at end. Let's craft HTML. Structure:

    About Us

    Flourish Research is where clinical trials thrive. Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

    About the Role

    We are actively hiring a Regional Regulatory Manager. This is a remote position. Shift: Monday-Friday (40 hours per week). Location: Remote- United States. PURPOSE: To oversee, manage and coordinate regulatory documents and activities throughout all clinical research studies conducted by the regional Flourish Research sites according to Flourish Research's SOPs, policies and procedures, applicable federal regulations, medical ethics, International Council of Harmonization (ICH), Good Clinical Practices (GCPs), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. To work closely with site leadership, principal investigators, and site staff. To collaborate with Sponsors, CROs, and IRB staff. Role functions begin at the time of study start-up, continuing through the duration of the trial, and until after study is deemed closed. All responsibilities should be completed in accordance with Flourish Research's Core Values and Employee Manual.

    Responsibilities

    • Provide guidance and support to ensure the team meets all regulatory requirements and deadlines
    • Manage and oversee full-time and contract employee Curricula Vitae and ensure copies of all current and applicable licenses and certifications are on file.
    • Regulatory lead for audits and inspections
    • Follow and ensure compliance with Flourish SOPs by team members
    • Manage the tactical and regulatory execution of awarded clinical research trials by overseeing timelines and staff for regulatory start up.
    • Oversee the preparation, submission, and maintenance of regulatory documents, including IRB submissions, amendments, and renewals.
    • Provide guidance on administrative and regulatory aspects for all areas within the assigned region.
    • Establish and maintain effective channels of communication and dissemination of vital communication with the regulatory team, site management/delegate, and RDO.
    • Collaborate with management to develop staff, structure department, and create a highly desirable work environment for attracting and retaining highly qualified professionals.
    • Develop and implement strategies through collaboration with the site and regulatory teams to identify and develop efficient systems and tools that enhance department efficiency, streamline regulatory processes, and improve overall efficiency, while maintaining quality.
    • Maintain a high level of professional expertise in the field and serve as SME for region
    • Manage activities performed by assigned team to improve organizational performance
    • Lead, mentor, manage, and train team members to foster growth and success of site(s) and team members.
    • Assist with screening/interviewing/hiring team members
    • Conduct annual performance reviews according to Flourish policies and procedures and foster a culture of continuous improvement.
    • Contribute to process improvement initiatives by identifying trends and areas for improvement
    • When necessary, perform verbal and written disciplinary procedures according to Flourish policies and procedures.
    • Manage requests for time off by team members as well as their daily/weekly schedules to ensure adequate staffing at all times to meet the demands and department workload.
    • Abide by all HIPAA regulations
    • Maintain confidentiality of sponsor trade secrets
    • Create error free written documents and reports
    • Perform all duties in a time- and cost-effective manner
    • Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
    • Additional duties as assigned by management

    Physical Requirements and Environmental Factors

    • Work is performed in an interior office work environment
    • Travel may be required up to 50%
    • Daily computer use
    • Participant care
    • Monitor/Sponsor customer service
    • Occasional evening and weekend work schedules
    • Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
    • Ability to drive and daily availability of an automobile

    Requirements

    Education: High School Diploma. College degree preferred. However, not required.

    Experience: Minimum of 5+ years' experience in clinical or biological research. (Minimum of 3 years in the department plus 2 years in related role within clinical research industry.)

    Knowledge and Skills:

    • Exceptional knowledge of clinical research methods
    • Strong management and leadership skills
    • Consistently demonstrates core values and high proficiency of skills set
    • Demonstrated ability to collaborate and align with operations
    • Must possess excellent interpersonal skills including written and oral communications
    • Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics and other employees.
    • Must have a strong work ethic, be motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments.
    • Develops and implements key initiatives in the department
    • Identifies and implements process improvements for increased efficiencies
    • Builds and fosters relationships across teams
    • Serves as preceptor, mentor and subject matter expert in department
    • Demonstrates strong critical thinking and decision-making skills resulting in sound judgement
    • Excellent computer skills to include Office365 products
    • Strong problem solving, risk assessment and impact analysis abilities
    • Demonstrated experience in process improvement
    • Flexible and able to multi-task and prioritize competing demands
    • Ability to think independently and influence when appropriate

    Benefits

    • Health, dental, and vision insurance plans
    • 401(k) with a 100% employer match on the first 4% of employee contributions
    • Tuition reimbursement
    • Parental leave
    • Employee referral program
    • Employee assistance program
    • Life insurance
    • Disability insurance
    • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays
    We need to ensure no extra blank lines? It's fine. Check we didn't include any boilerplate like EEO. Good. Check we didn't repeat job title as heading. We used About the Role, not the title. Check we didn't include Pay or Schedule sections. We