- Developing and managing relationships with stakeholders at all levels of the business and playing a lead role in embedding a good compliance culture
- Performing routine compliance monitoring and periodic compliance audits to evaluate organizational compliance with its policies, procedures and applicable regulatory standards. Collaborates with impacted parties to develop and implement corrective action plans to address monitoring and audit findings.
- Responsible for the execution of day-to-day Spend Transparency program activities, including but not limited to program governance and compliance, proper spend data capture practices, support for certification and submission, inquiries and dispute resolution, training, communications, monitoring, auditing and data analytics.
- Maintain company compliance policies and procedures - work with team members to ensure they understand their roles and responsibilities defined in the specific compliance-related policies and procedures.
- Coordinate with supporting consultants and third party vendors to drive compliance activities.
- Oversee portfolio of required business licensed to ensure they are properly maintained and meet compliance and regulatory requirements.
- Serve as administrator and/or liaison to multiple data repository/reporting systems including those related to transparency reporting and data analytics
- Provide advice and support to business units on reporting and documentation requirements
- Partner with third-party vendors to continuously improve reporting systems and practices
- Other compliance-related tasks as assigned
- Bachelors degree and a minimum of 4 years experience, some of which should ideally be healthcare/compliance experience in Life Sciences field, or equivalent combination of education, training, and experience.
- Knowledge of PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals.
- Knowledge and experience in producing transparency reports and working with aggregate spend data reporting systems.
- Excellent interpersonal and communications skills.
- Project management experience preferred.
- Experience in drafting policies and managing compliance training programs preferred.
- Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners required.
- Healthcare Compliance Certifications a plus
- Highest level of integrity and ethics, and a commitment to maintaining the highest standards of compliance
- Strong written and oral communication skills, including the ability to communicate complex concepts to all organizational levels, including senior management.
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Compliance Manager - Florham Park, United States - Phathom Pharmaceuticals
4 weeks ago
Description
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.
We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.
The Manager, Compliance will be responsible for supporting the Compliance Team and activities related to Pharmaceutical Healthcare Compliance and will report to the Director, Legal and Compliance. We are seeking candidates with strong communication skills, analytical acumen, attention to detail, and interest in being fundamental to the success of the overall organization. We welcome candidates with various background experience, with a focus on those driven to learn and excel.
Accountabilities:
Education & Experience:
