Senior Compliance Manager Developed Markets
il y a 2 semaines
At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.
Next to a competitive salary with extensive benefits, we offer you the chance to grow and be a part of a team driven by purpose, creativity, innovation and science.
argenx
argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
PURPOSE OF THE FUNCTION
The Sr. Manager Compliance is a key member of our globally operating Compliance team who will mainly support our commercial and medical operations in the European Region incl. Australia and Canada. This is an opportunity to further develop a best-in-class compliance program by role modeling the business partnership with all functions within argenx. In this role you will be a key advisor across the product life cycle and an enabler of successful product launches and commercialization at a regional and country level. The responsibilities will include advising on key projects and day to day activities, developing policies or other written standards and training materials incl. providing trainings in the countries, supporting with auditing and performing monitoring activities and other general compliance activities and specifically fostering the strong ethical culture of argenx.
ROLES AND RESPONSIBILITIES
In close collaboration with the compliance colleagues, this role is responsible for high quality and timely guidance in all areas of the business, customer facing activities, and country specific compliance issues. The role will actively lead and contribute to compliance projects, issues, and priorities across the global legal and Compliance function.
Your primary areas of focus are:
- Advise the business functions regarding compliance and continue to evolve the global compliance program in the region and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable legal and regulatory requirements.
- Serve as an advisor to regional and local commercial and medical teams to provide compliance-based input and direction across product portfolio.
- Review and advise on interactions with patients, healthcare professionals, institutions, payors, regulatory agencies and other external stakeholders.
- Draft and implement appropriate policies, procedures and guidance, in collaboration with the Head of Compliance DM & Germany, legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the respective countries and region (excluding cGMP, cGCP and other GxP guidelines).
- Support adherence to transparency reporting requirements and reporting obligations where required.
- Conduct or assist in compliance-related investigations and other allegations of misconduct, as required.
- Prepare and deliver Ethics & Compliance training and education to the organization incl. field-based employees to ensure understanding of employee responsibilities and overall Ethics & Compliance framework, as well as related policies and procedures.
- Foster the strong ethical culture of argenx.
- Other duties as assigned.
- Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential.
- Team-player, able to work well with others and communicate with cross-functional colleagues and senior leadership.
- Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner in a multi-cultural and multi-lingual global environment.
- Shows flexibility and is open to change in a growing, multi-cultural environment; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company's business and culture.
- Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying Ethics & Compliance and other business risks; capable of strategic thinking and proposing innovative solutions to compliance-related challenges.
- Solid understanding of business goals and legal, compliance and regulatory landscape in Europe.
- High degree of personal, professional and corporate ethics, integrity and responsibility.
- Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment.
- Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.
- 4-7 years of biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company.
- Legal degree preferred, other relevant accreditations or degrees considered.
- Fluent in English; other language skills preferred.
- Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential.
- Expertise in the areas of European corporate commercial healthcare law and regulation related to the development and commercialization of pharmaceutical products.
- Experience in specialty markets, particularly rare diseases, preferred.
- Expertise in the relevant industry codes and guidelines.
- Travel 25-30%.
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