Posted on: 9/26/2022

Job type: Permanent

Sector: Pharmaceutical and Healthcare

 
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Company profile
As an expansion into the US market, this innovative Asian pharmaceutical company with well-respected products is growing their operations and management team. The US expansion is being driven by the growing demand for our client’s products. With the investment in the growth in the US, they will be able to accommodate their increasing customer needs. The company has been very successful globally. Our client’s organization engages in the development, manufacture and distribution of pharmaceuticals. It operates through the Biopharmaceuticals, Chemical Drugs and Others businesses. Its products include remsima and biosimilars. They are in the Forbes 100 Most Admired Companies & on the Forbes Most Innovative list.

What we are looking for:
A Compliance Manager that will be responsible of the development and implementation of the client USA’s compliance 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.
Location: Jersey City, NJ

Main Responsibilities:
  • Develop, implement, and lead the compliance program, including drafting relevant policies and SOPs, conducting compliance training programs, and monitoring interactions with HCPs in accordance with current industry guidance and trends, as well as their global compliance framework.
  • Identify potential gaps in the compliance program (e.g., policy, procedure, or training) through ongoing monitoring activities and implement appropriate enhancements.
  • Responsible for transparency report under the Sunshine Act, working with external vendors who support the compliance program.
  • Provide 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.
  • Establish and lead an internal compliance review committee.
  • 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.
Candidate Requirements:
  • +5 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
  • 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

Contact

Eugenia Trinidad
00 52 55 1998 4000
Morgan Philips Executive Search
Av. Miguel Cervantes Saavedra 233 - Piso 9
CP. 11520 - CDMX Col. Granada – Del. Miguel Hildalgo
Mexico

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Reference: US844455
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