Associate, Global Compliance External Engagement

Job Description

Pay: $45 - $55/hr
7-month assignment on W2 with a possibility for extension based on performance and budget
Job Schedule: Average of 20 hours per week, can increase depending on coverage for another individual. Can work 100% remote; prefer EST based, schedule 10AM-2PM EST - Monday-Friday.

Key Responsibilities

• Independent management, organization and administration of the CBER process by conducting intake and distribution of all CBER requests in the Global CBER portal.
• Ensuring that all CBER submissions are complete, qualify for CBER, and contain all required documentation prior to distribution to CBER Reviewers.
• Responsible for coordinating the review/input for all countries that are implicated in the CBER request.
• Interact directly and frequently with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to the review of CBER submissions.
• Independently provide explanations and details of requests to applicable committee members.
• Provide status updates to the Business Requestor upon their request.
• Provide review-related input from Local Country-level Reviewers to all CBER Committee members for consideration in their assessment of the submission.
• Follow up on outstanding requests and communicate the final CBER Committee determination to the Business Requestor.
• Conduct close-out of all submissions including ensuring that all necessary documentation has been obtained, is included in the electronic file and is maintained in accordance with record retention requirements.
• Conduct independent initial review ("first line review") of all planned CBER requests originating from Business Requestors to determine if they (1) require CBER review and (2) if proposed engagements comply with applicable healthcare laws/regulations, internal policy and procedure requirements.
• Make decisions/provide feedback to the CBER requestors regarding actions to be taken on each request.
• Responsible for flagging issues pertaining to anti-kickback, false claim, and transparency reporting laws/regulations for additional Compliance or Legal Affairs review.

Qualifications

• This role is intended for a pharmaceutical compliance or legal affairs professional with experience managing complex processes, systems, and time-sensitive reviews.
• The position requires the ability to work independently, make sound decisions, and manage a high volume of high-risk reviews.
• Candidates should have knowledge of U.S. healthcare rules, particularly as they relate to payments and engagements with HCPs, customers, and patients.
• A minimum of one year of pharmaceutical industry experience is required, with a strong preference for experience in compliance, legal affairs, or policy.
• Bachelor's degree is required.

Benefits

Our company offers our contractors a suite of benefits after a qualification period including health, vision, dental, life and disability insurance.