Informationsbeauftragte / r & Compliance Manager DACH (m / f / d)

Idorsia; München; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Idorsia seeks an Information Officer and Compliance Manager in Munich to support regulatory compliance and manage scientific information. Ideal candidates will have at least 7 years' experience in the pharmaceutical industry and possess strong communication skills in both German and English. This permanent role offers exciting growth opportunities within a collaborative environment and a competitive salary.

Leistungen

Competitive salary

Flexible home office options

Professional growth opportunities

Dynamic and collaborative environment

Modern office in Munich

Qualifikationen

• Minimum 7 years in pharma, 2+ years in Compliance.
• Expertise as per §74a AMG.
• Thorough knowledge of German and EU compliance.

Aufgaben

• Ensure compliance with applicable laws in Germany and Austria.
• Deliver training on the Code of Business Conduct.
• Manage internal controls and audit preparation.

Kenntnisse

Compliance Management

Pharmaceutical Legislation

Communication

Negotiation

Organization

Training

Bilingual (German and English)

Ausbildung

University degree in Medicine, Biology, Pharmacy, Chemistry

Jobbeschreibung

We would love to welcome you in our team in Munich / Germany as

About Idorsia

The purpose of Idorsia is to discover, develop and bring more innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we would like to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Idorsia is headquartered in Switzerland and has already established commercial operations in the US, Canada and major strategic locations in Europe.

With the german commercial operations based in Munich, we are helping to realize Idorsia’s ambition of bringing innovative medicines from bench to bedside.

Job Profile

The job profile covers 2 strategic areas :

As our Information Officer (Informationsbeauftragte / r) you will be part of the Medical team and ensure that all scientific and promotional information about our medicines is accurate, up-to-date, and compliant with the regulations.

As Compliance Manager you will be responsible for all compliance related topics in our affiliates in close collaboration with our European Compliance and Legal function.

Your tasks involve but are not limited to :

Information Officer

• ensures that the tasks of providing scientific information on medicinal products are performed responsibly in accordance with applicable law in Germany and Austria. (for example : Section 74a AMG (Arzneimittelgesetz) and the HWG (Heilmittelwerbegesetz).
• ensures that suitable processes for the review and approval of scientific information and promotional material are created and adherent to.
• must ensure all product-related informationincluding labeling, package insert, SmPC, and advertising are consistent with the content of the marketing authorization.

Compliance Manager

• is responsible for ensuring an appropriate Business Conduct and represents Idorsia Compliance locally
• delivers training on the Code of Business Conduct as well as on any other Compliance related processes and policies
• ensures the compliance with and implementation of Idorsia and applicable regulatory guidelines andstandards, assuming ownership of assigned internal controls
• takes ownership for the review of Health Care Professional (HCP) engagements through the digital review tool
• stays abreast with trends and advises employees on compliance standards under the leadership of the Head of Legal and Compliance EUCAN : assists in and performs the local Compliance Monitoring in accordance with Idorsia’s Monitoring program supports the Head of Legal & Compliance EUCAN in potential investigation proceedings
• proactively and reactively supports and advises the business concerning all compliance relatedactivities
• set Idorsia’s tone towards compliance, promoting positive involvement in internal control andcompliance activities
• fosters development of compliance and audit awareness / participation and promotes cross-functionalcommunications
• supports in audit preparations and assist during audits, coordinates timely implementation ofremediation actions for identified internal and external audit findings.

Requirements

• University degree in Medicine, Biology, Pharmacy, Chemistry or other related disciplines
• At least 7 years of professional experience in the pharmaceutical industry of which at least 2 years in Compliance, Legal or Medical functions
• Necessary expertise and required reliability according to §74a AMG (Arzneimittelgesetz)
• Excellent understanding of the pharmaceutical industry practices
• Thorough knowledge of the Legal / Compliance landscape in Germany, Austria and Switzerland including the Health Care Compliance environment and a solid understanding of the FSA Codex (Freiwillige Selbstkontrolle der Arzneimittelindustrie)
• Good communication, negotiation, organization and training skills
• Excellent language skills in German and English.

Next to your personal requirements you should be also familiar with the Idorsia values :

Advance : To achieve our ambitious goals, we move forward with energy and vigour. We take full responsibility for finding solutions and outperforming the competition.

Pragmatic : Whatever the challenge, we are flexible and pragmatic in implementing initiatives without compromising the quality of our work.

Invent : To seize more opportunities, we are resourceful, creative, and imaginative. Our work is scientifically orientated, and data driven. We are open to novel approaches in all areas.

Team-up : We enjoy working as a team and use the power of our shared passion. We work collaboratively, share information and exchange ideas, listen to each other, and support each other.

• Exciting opportunitiesfor development and professional growth within our dynamic organization.
• A collaborative and solution-oriented environment where you can make a difference.
• An innovative and open culture in a multicultural environment.
• A competitive salary and a variety of additional benefits.
• A state-of the art office in the heart of Munich with flexible home office options.

Country : Germany

Business Area : Global Medical Affairs

Job Type : Permanent