Regulatory affairs specialist Jobs in Creußen

Join argenx

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.

For the expansion of our EMEA team, argenx is looking for a Medical Science Liaison in Germany.

PURPOSE OF THE FUNCTION

The Medical Science Liaison (MSL) is a field-based expert on argenx’s scientific data, products and trials, responsible for engagement with medical stakeholders at centers across the region but also with patient groups, policy makers and government payors. The MSL will represent and reflect argenx’s values as a science-driven, patient-centric organization. The MSL is critical in understanding the management of diseases of interest, mapping the patient journey, identifying unmet medical needs, data gaps and areas of collaboration. The MSL will work closely with the regional team, the EMEA Medical Affairs team and cross-functionally with all relevant EMEA colleagues. While the focus will be on the region, the function will also support activities and projects across the EMEA region.

ROLES AND RESPONSIBILITIES

Expert medical resource and argenx ambassador

Maintain the highest scientific and medical expertise of all relevant diseases and, products; be acknowledged internally and externally as an expert.

Identify and develop productive relationships and collaborations with all relevant stakeholders, including healthcare professionals, professional organization.

Support the development and implementation of Medical Affairs plans to advance argenx objectives.

Support market access activities and any healthcare policy efforts across the region.

Help shape the position of argenx in the region.

Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of argenx policies and procedures.

Scientific / medical exchange and education, and insight generation

Ensure timely and informative scientific / medical exchanges with external stakeholders that accurately reflect scientific data.

Deliver high quality scientific / medical education in a variety of settings, including related to diseases of interest, clinical studies, investigational products and any future licensed products.

Obtain feedback that can be disseminated throughout the organization.

Coordinate the timely and appropriate response to internal and external Medical Information enquires, utilizing argenx medical information resources and in line with regulatory requirements.

Attend appropriate local, national and international meetings and congresses to gather intelligence, develop productive collaborations, engage in scientific exchange and ensure insights are shared within argenx.

Cross-functional collaboration

Ensure a close working relationship with all argenx functions

Support cross-functional teams to ensure operations are patient-focused, including rapidly responding to internal and external requests to discuss specific situations and challenges and provide medical affairs support to all stakeholders.

SKILLS AND COMPETENCIES

Entrepreneurial spirit and ability both achieve results independently and partner with colleagues across functions and geographies.

Strong influencing skills to be able to engage effectively with stakeholders and within the company.

Ability to quickly understand :

complex disease areas, treatments and clinical development plans

healthcare landscape, hospitals, healthcare professionals, patient journey

the broader healthcare policy context including especially market access processes.

Demonstrated ability to build productive collaborations with medical experts

Excellent communication skills : verbal, written and when giving presentations

Proven track record of delivering results that meet or exceed targeted objectives

Ability to work collaboratively and effectively together within cross-functional teams and networks

Demonstrated communication skills, within a multi-cultural and multi-lingual global environment

Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, and resilience

Derives energy from operating in a dynamic, complex, fast-moving, and frequently changing business environment

Demonstrable experience with project management, proactive planning, priority setting, and securing alignment

Drives toward outcomes

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.

EDUCATION, EXPERIEN CE

Scientific, healthcare or medical degree (MS, PharmD, PhD, MD, RN, PA)

Significant field-based experience in a biopharmaceutical industry in medical affairs

Clinical experience in neurology, immunology and / or rare diseases is an advantage

Knowledge of regulations and practices related to industry interactions with healthcare professionals

OTHER

Valid driver’s license

Ability for ≥50% travel