Job details

Manager, Compliance Operations

Position Overview:

Mayne Pharma is currently recruiting a team-oriented, dynamic, and enthusiastic compliance professional to assist in the implementation and operations of Mayne Pharma’s compliance program.

The Compliance Operations Manager will be a key part of Mayne Pharma’s Compliance & Risk team and will collaborate with internal and external stakeholders to implement a best-in-class compliance program. The ideal compliance professional will possess solutions-oriented pragmatism, excellent communication skills, and attention to detail. The Compliance Operations Manager will drive accountability together with business leaders to generate trust from customers, business partners, and patients.

This position is based in Raleigh, NC and reports to the VP, Global Head Compliance & Risk.

Specific Responsibilities

Assist in the development, revision, and pull through of policies, procedures, and training
Implement planned transparency reporting program, including federal and state aggregate spend reporting, certification, and disclosure
Support Mayne Pharma’s cross-functional privacy initiatives and project plans to ensure on-track, timely completion in compliance with all applicable laws and codes
Support execution of Compliance Committee materials and activities
Operationalize Mayne Pharma’s compliance training program, including collaborating with internal stakeholders on assignments and communications plans
Perform training as needed for new hires to introduce values-based decision making and compliance program
Implement planned audits and monitoring activities as applicable, trending and reporting results to the Compliance & Risk team, Compliance Committees, and other business stakeholders.
Transactional review of business activities, such as advisory boards, speaker programs, sponsorships/exhibits, and medical education initiatives for FCPA, fraud and abuse, FDA and other regulatory agency compliance, as well as in consideration of transparency reporting, anti-kickback, anti-bribery, antitrust, privacy, and product liability laws, rules, regulations, and guidance
Provide administrative support for internal investigations, including managing the intake process for concerns received through the company hotline, conducting a high-level review and triage of investigations, scheduling interviews, and assisting with gathering supporting documents.

Key Competencies/Requirements:

Bachelor’s degree required
Minimum of 3 years of compliance experience in the Pharmaceutical/Biotech/Life Sciences industry
Outstanding skills and proven track record working with business owners on writing and modifying policies/SOPs
Demonstrated pragmatism and operational focus, seeking to assist others in finding practical, business solutions.
Sound, agile decision-making and interpersonal/networking skills.
Strong oral and written communication skills.
Must be detail-oriented, precise, and meticulous when reviewing data and records amid demanding deadlines.

Preferred Qualifications:

Knowledge of Sunshine Act and state transparency reporting, preferably experience with Open Payments
Privacy experience desired

Physical Requirements:

Occasional travel required

General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat". All official communication from Mayne Pharma will be received from our company email domain - @maynepharma.com.

By Mayne Pharma

Mayne Pharma is a company that delivers pharmacy drugs to commercialize branded and generic pharmaceuticals. The company headquarters is in Salisbury South, South Australia.

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FUNDING

Public

DEPARTMENTS

Legal, Compliance

SENIORITY LEVEL REQUIREMENT

Mid-Level

INDUSTRY

Health Care

TEAM SIZE