Manager Clinical Affairs (f/m/d) Job Details | STADA Arzneimittel AG

STADA; Bad Vilbel; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Manager für Klinische Angelegenheiten, der für die Planung und Durchführung klinischer Studien verantwortlich ist. In dieser spannenden Rolle koordinieren Sie Projekte, überwachen externe Partner und stellen die Einhaltung von GCP-Standards sicher. Mit einem klaren Fokus auf Bioäquivalenzstudien und der Zusammenarbeit in einem dynamischen, internationalen Team haben Sie die Möglichkeit, Ihre Karriere in der pharmazeutischen Industrie voranzutreiben. Profitieren Sie von flexiblen Arbeitszeiten, individuellen Entwicklungsmöglichkeiten und einer offenen Unternehmenskultur, die Ihre persönliche Entwicklung fördert.

Leistungen

Flexible Arbeitszeiten

Mobiles Arbeiten

Jobticket für die RMV-Region

Kindergeldzuschuss

Gesundheitsfördernde Angebote

Subventionierte Cafeteria

Zukunftszahlungen

Gruppenunfallversicherung

Zusätzliche Altersvorsorge

Qualifikationen

• Mindestens 2 Jahre Erfahrung im Projektmanagement klinischer Studien.
• Erfahrung mit Bioäquivalenzstudien und Kenntnisse in Biopharmazie.

Aufgaben

• Planung und Durchführung klinischer Studien von Phase I bis IV.
• Koordination von klinischen Studien und externen Partnern.

Kenntnisse

Projektmanagement von klinischen Studien

GCP-Kenntnisse

Bioäquivalenzstudien

Biopharmazie

Pharmakokinetik

Fließend in Deutsch und Englisch

Ausbildung

Abschluss in Pharmazie oder Medizin

Jobbeschreibung

Caring for People's Health as a Trusted Partner - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Manager Clinical Affairs (f/m/d)

Bad Vilbel|Germany (DE)|Full-time|Permanent|Portfolio & Product Development|Professionals

In your role as Manager Clinical Affairs, you will be responsible for the planning, preparation, and project management of clinical studies from phases I to IV, with a focus on bioequivalence studies. You will oversee the conduct of the clinical studies according to national and EU/ICH law and ensure compliance with GCP standards.

What you can expect:

• You will develop scientific evaluations and clinical study strategies.
• As a project manager, you will coordinate clinical studies and supervise contract research organizations and external partners.
• A key task of your responsibilities is the review of clinical study documents.
• As a clinical point of contact, you will accompany development projects from the product idea to dossier approval.
• You will assess clinical studies within the framework of in-licensing and due diligence projects.
• You will prepare scientific opinions and responses to Assessment Reports as part of the approval processes.

Who we are looking for:

• You have a degree in pharmacy or medicine.
• You have at least 2 years of professional experience and a proven track record in project management of clinical studies (pharmaceutical industry, contract research organization).
• You have sound knowledge of GCP.
• You have proven experience with bioequivalence studies and knowledge in biopharmacy and/or pharmacokinetics.
• Ideally you have experience with orphan drug development.
• You are fluent in both German and English.
• You approach your tasks systematically, independently, and responsibly, and are willing to take on cross-functional tasks.

What we offer:

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development.
• Individual development and training opportunities.
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile).
• Job ticket for the RMV region and Job Bike.
• Childcare allowance.
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge).
• Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund.
• Subsidized cafeteria.

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to [e-mail]. Part-time requests are considered on an individual basis.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment. #LI-HYBRID #LI-DH1