Projektassistenz Pharma (m/w/d) (Ingenieur/in - Pharmatechnik)

"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 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 . 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 . 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

Ihre Aufgaben:

- Allgemeine Unterstützung der Manager im Bereich der Zulassung
- Dokumentenmanagement
- Verwaltung und Pflege des Dokumentenmanagementsystems
- Sicherstellung der korrekten Ablage und Archivierung vorhandener Dokumente im System
- Buchung von PO Nummern
- Unterstützung bei der Erstellung und Verwaltung von Bestellungen im SAP
- Ablage

Ihre Qualifikationen:

- Erfolgreich abgeschlossene kaufmännische Ausbildung
- Erste Berufserfahrung im Bereich Sachbearbeitung / Projektassistenz wünschenswert
- Erfahrungen im Umgang mit MS Office
- SAP Erfahrung
- Sehr gute Englischkenntnisse in Wort und Schrift

Ihre Vorteile:

- Internationales Unternehmen

Über Hays:

Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie, Biotechnologie, Chemie und Medizintechnik kennen wir die entscheidenden Kontaktpersonen, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Fach- und Führungskräfte, um sich beruflich zu entwickeln und an der eigenen Karriere zu arbeiten. Als spezialisierte Personalberatung mit einem internationalen Netzwerk bieten wir Ihnen entscheidende Vorteile - und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.