Overview:
We are currently looking to recruit a **Legal & Compliance Specialist Italy & Iberia.
** Based in one of our offices in Rome, Italy and or Home-based reporting to the General Counsel and Compliance Officer EMEA will be responsible for the following:
**Responsibilities**:
**Legal & Compliance Specialist Italy & Spain** is responsible for providing Legal advice, counsel and services to domestic and international businesses in support of customer, vendor, supplier, and strategic relationships, including drafting and negotiating contracts, participating in and providing input on business strategy, and otherwise acting as primary day-to-day legal contacts for business clients.
- Applies advanced knowledge and understanding of concepts, principles and technical capabilities to manage a wide variety of projects
- Participates in the development of policies and procedures to achieve specific goals
- Recommends new practices, processes, metrics, or models
- Works on complex projects of large scope
- Projects may have significant and long-term impact
- Provides solutions which may set precedent
- Receives guidance on overall project objectives
- Acts as a mentor to less experienced colleagues
**Compliance**:
- Set the strategic direction of the Italy & Iberia Compliance program together with the Legal & Compliance Leader
- Be part of the business management team as well as of the EMEA Legal & Compliance management team
- Compliance Monitoring of Business Activities, Medical Events and Interactions with Healthcare Professionals ("HCP") and Healthcare Organizations ("HCO");
- Support the Legal & Compliance Leadership to evaluate all activities that require compliance pre-approval before payment, ensure process transparency, documentation completeness and archiving;
- Deliver compliance related policy training, monitor and ensure continuous training;
- Support investigations on compliance concerns raised by management, employees or others;
- Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation; recommending opportunities to strengthen the internal control structure
- Audit of accounting and other records for the purpose of compliance audit with focus on key compliance risk areas, including:
- Payments to HCP and fair market value
- Local medical events
- Grants, sponsorship, donation and charitable contribution
- Fees to hospitals
- Transactions with HCO and medical associations
- Off label promotion
- Distributor and third party intermediaries due diligence
- Employee expense reports
Qualifications:
- Education: Juris Doctorate degree or equivalent degree which qualifies to practice law in Italy or Spain
- License to practice law in Italy or Spain and or active bar license in another state
- Languages: fluency in Italy or Spanish and English both oral and written, is a must
- Excellent communication skills, both written and oral
- Minimum of 2 years relevant work experience in the Life Science or Medtech industry
- Familiarity with the medical device or pharma industry and medical device or pharma legal & compliance
- Forensic auditing/investigation training, including technology use;
- Experience working for US-based or multinational company would be an asset.
- Flexibility to Travel up to 20 %