What are the responsibilities and job description for the Associate Director (Legal and Compliance) position at Makonis?
Client: A Leading Pharma Manufacturing Brand
Work Location: Jersey City, NJ
Required Area of expertise: Compliance, Legal, Federal Laws, Sunshine Act etc.
Position Summary:
- Reporting to the General Counsel of Company, manage the Company’s daily Compliance operations that includes the development and implementation program, policies and procedures to ensure compliance with all applicable federal and state laws, regulations and delegation requirements in a legal and ethical manner.
- Work collaboratively across the organization to create a culture of compliance awareness by identifying risks and gaps and building training modules around best practices.
Role and Responsibilities:
- Propose and support the development, implementation of compliance programs, including drafting relevant policies and SOPs, conducting compliance training programs, and monitoring interactions with HCPs in accordance with current industry guidance and trends, compliance framework.
- Manage the transparency report under the Sunshine Act, working with external vendors who support the compliance program.
- Support in providing business advice to ensure compliance with applicable US laws and company policies, including federal and state anti-kickback and false claims laws, anti-bribery/anti-corruption laws, the Food Drug and Cosmetic Act, federal, state and international transparency laws, and applicable industry codes.
- Perform compliance trainings to both local and HQ colleagues transferred and assigned in the NJ office.
- Manage and conduct compliance investigations into alleged violations of the compliance policies and identify appropriate corrective actions as needed.
- Manage a data protection program to ensure organizational and clinical trial data maintain their integrity and confidentiality through secure data storage and access.
Work Experience:
- 10 years of experience working as a compliance professional for a pharmaceutical company.
- Strong knowledge of the regulatory requirements in the US pharmaceutical industry
- Knowledge of the Sunshine Act reporting and other state government reporting requirements
Skills and Specifications:
- Comfortable implementing systems/processes to ensure compliance with laws/regulations.
- Experience leading data protection for a pharmaceutical organization.
- Knowledge of applicable commercial and compliance requirements, risk management practices and methodologies
- Comfortable working in a fast-paced and evolving environment and demonstrated ability to evolve and align the legal and compliance functions with changing business needs.
- Strong verbal and written communication skills, including leading compliance training and experience presenting to a board meeting and its committees.
Education (Preferred):
- Juris Doctor from an accredited US Law School
- Admission to the New Jersey bar
If your profile aligns with the job description above, please do share a copy of your resume to gunjan.t@makonissoft.com at an earliest.
