EU Compliance Manager
1 month ago
At Amarin, you’ll make a difference.
Our vision is to one day reach the moment when heart disease is no longer the #1 cause of death in Europe. Bold, we know. But it’s what drives us every single day. Knowing that because of what we do, someone, somewhere is less likely to have a heart attack or stroke. That’s making a real difference if you ask us.
Even though we’ve been around for a while, in Europe, we’re starting from scratch. Building the organization, setting up the processes, educating people, delivering therapies. And we’re doing it in record time. In today’s life science industry, that’s unique. Some might even say “once-in-a-lifetime”.
So if you’re looking for a company where you’ll be at the start of an amazing journey, a company that’s introducing a new era in cardiovascular care in Europe based on groundbreaking science, a company where you can really apply your experience, are empowered to innovate, where hard work is rewarded, and above all where you can make a true difference in people’s lives, Welcome
And at Amarin, we also count on each other. Teamwork and collaboration are essential. We support each other, challenge each other and help each other. Across all functions and countries. We focus on moving forward, aren’t afraid of mistakes and leaders are just a (video) call away. Because we know that together, we achieve more. Working with some of the brightest in the industry, each as knowledgeable, determined and committed to our vision as the next, you’ll achieve more too.
The EU Compliance Manager will give support in developing, implementing and maintaining a robust, dynamic and effective compliance and data privacy (GDPR) program, helping to ensure that Amarin is compliant with all laws, regulations and country and industry codes of conduct applicable to the company. You will manage, implement and administer the activities within Ethics & Compliance along with standards for appropriate business conduct and overseeing investigations of wrong-doing.
Responsibilities/Major Accountabilities:
The EU Compliance Manager will have responsibilities in the following tasks:
- Support with the data privacy materials and processes to ensure Amarin compliance with the GDPR and local country requirements, including administrating the GDPR Tool (e.g. maintaining ROPAS, supporting the business in Privacy Notices and Consent Management).
- Supporting the process steps, including set up and being consistent of creations, reviews and updates of Compliance Policies and SOPs.
- Requesting standard technical and operational measures – reviewing them for appropriateness.
- Support in developing and implementing Group compliance policies and standard operating procedures, training materials, education, communications materials and monitoring programs for Europe, with providing Live Trainings and Training Videos to employees.
- Monitoring and analysing the regulatory environment in which Amarin operates, and support with overseeing necessary changes to compliance policies, training materials and processes.
- Supporting Transfer of Value / Disclosure Reporting globally (US, Europe).
- Establishing an internal framework with regular spot checks, sampling and evolving and preparing Compliance Dashboard and Global Monitoring Program.
- Aggregate spend data collection and reporting systems, processes and reports - duties like collection invoices from A/P for all HCP HCO interactions for reconciliation against payments and contracts for all European countries.
- Assists in the development of analytics to measure company compliance and performance of the Compliance Department, and preparation of relevant analytics reports
- Safeguarding consistency across Compliance Policies and SOPs against standard templates across countries and support in creating country-specific processes , roll out to all countries including management of translations.
- Requires very limited occasional travel, within Europe.
Experience and Education:
- Bachelor/Masters degree in Science or Law or Business Administration
- Fluency in English, any additional languages is a plus.
- At least 3-4 years corporate experience.
- At least 2 years experience already working within a compliance role, preferably in pharma/ biotech business or regulated industry a compliance role preferably in pharma/ biotech business.
- Data privacy experience.
- Experience drafting and implementing procedures, SOPs and training materials.
- Experience in supporting set up and consistent of creations, reviews and updates of Compliance Policies and SOPs.
- Working with a cross-functional team.
- Knowledge about applicable laws and regulations preferred.
Key Competencies:
- Entrepreneurial spirit with pragmatic approach
- Subject matter knowledge
- Negotiation, collaboration, persuasion, communication and relationship building skills
- Highest level of integrity
- Team / line management
- Independence, initiative, motivation and leadership by example and persuasion.
- Discreet and able to protect confidential information
- Role model for ethical behaviour
- Problem solving and solution orientation
- Personal and professional maturity
- Ability to prioritize and to work independently as well as efficiently
- Interpersonal and collaboration skills, with an ability to influence non-Compliance colleagues, including senior and executive management.
- Good Communication and Presentation skills
- Sound judgment, common sense and practicality
- An inquisitive mind, positive attitude and strong work ethic
Organizational Values:
- Operational Excellence
- Collaboration
- Commitment to Quality
- Integrity
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